Education and Music Intervention to Reduce Anxiety: feasibility, potential efficacy and patient satisfaction in a pilot study

Education and Music Intervention to Reduce Anxiety: feasibility, potential efficacy and patient satisfaction in a pilot study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Education and Music Intervention to Reduce Anxiety: feasibility, potential efficacy and patient satisfaction in a pilot study Letícia de Carvalho Batista, Milena Santos de Oliveira, Juliana Paulucci Reis, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3877284/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 22 Oct, 2025 Read the published version in Pilot and Feasibility Studies → Version 1 posted 4 You are reading this latest preprint version Abstract Background People undergoing cardiac catheterization experience anxiety. Musical and educational interventions have been tested separately and have been shown to reduce anxiety in this patient profile. This pilot study aimed to assess the feasibility and potential effectiveness of a complex intervention called Education and Music Intervention to Reduce Anxiety (EMIRA), in addition to participant credibility, expectations and satisfaction. Methods This is a randomized, blind, pilot clinical trial, carried out in an emergency department specializing in cardiology. Feasibility was assessed according to recruitment, retention, attrition and recruitment time rates. The potential for efficacy was assessed through the effect of EMIRA on state anxiety, blood pressure, heart rate, respiratory rate and chest pain intensity, comparing the intervention group (IG) and control group (CG) before (T1), immediately after (T2) and two to four hours after (T3) the intervention. To estimate participant satisfaction with the intervention, a visual numerical scale was used. Participant credibility and expectations regarding EMIRA were determined using a previously validated instrument. The significance level adopted was 5%. Results A total of 47 potential participants were approached over a period of 54 days. Recruitment, retention, and attrition rates were, respectively, 93.6%, 90.9%, and 10%. No participant withdrew from continuing in the study after recruitment. No significant difference was observed between CG and IG in relation to the analyzed outcomes. The mean score for satisfaction, credibility and expectations were high. There was a negative correlation between satisfaction and the difference in SBP between T1 and T2. Conclusions EMIRA is a complex intervention with an educational and musical component. The results suggest that a larger-scale clinical trial is feasible, participants were satisfied and had positive attitudes towards the intervention. However, EMIRA did not promote a significant change in the outcomes analyzed. Trial registration RBR-857nczs Anxiety Cardiac Catheterization Nursing Randomized Controlled Trial Health Education Acute Coronary Syndrome Music Therapy Figures Figure 1 Figure 2 Key messages regarding feasibility 1) What uncertainties existed regarding the feasibility? Before this study, the feasibility of a complex intervention consisting of an educational and musical component in patients undergoing unscheduled cardiac catheterization in the emergency department was unknown. 2) What are the key feasibility findings? EMIRA was a no-dropout intervention, with high recruitment and retention rates, short recruitment time and low attrition rate. 3) What are the implications of the feasibility findings for the design of the main study? The results of this pilot study provide evidence that a larger randomized clinical trial testing EMIRA is feasible in the emergency department. Future studies should test the effectiveness and feasibility of EMIRA in other clinical units. Background Cardiac catheterization is the procedure of choice for risk stratification and treatment of acute coronary syndrome (ACS). ( 1 , 2 ) It is one of the most performed procedures in the world, with a risk of serious complications and mortality is less than 1%. (1, 3) Although cardiac catheterization is routinely performed in specialized hospitals, it is often unknown to patients and can exacerbate symptoms of anxiety. ( 3 ) Anxiety related to cardiac catheterization (ARCC) can be defined as an unpleasant feeling of worry, concern and/or nervousness characterized as an adaptive phenomenon associated with cardiac catheterization, pain, hospitalization, fear, lack of knowledge or uncertainty. ( 4 ) This is a highly prevalent phenomenon in the perioperative period of cardiac catheterization. ( 5 – 7 ) In fact, ARCC incidence is highest in the 24 hours preceding the procedure, affecting between 61% and 90% of patients awaiting the procedure. ( 5 – 7 ) ARCC has been associated with higher rates of complications both during the procedure and in the subsequent months. ( 8 – 16 ) Therefore, the preoperative period seems to be the ideal time to apply interventions aimed at managing ARCC. ( 8 – 16 ) Several non-pharmacological interventions have been tested for managing ARCC and other manifestations of anxiety, such as changes in vital parameters. Interventions with music and educational interventions, applied in isolation, are among the most studied as they are considered safe, cheap and easy to administer. ( 17 – 19 ) However, the literature on the effect of music and educational interventions on reducing ARCC, blood pressure (BP), heart rate (HR) and pain is controversial, which can be explained, in part, by the heterogeneity of interventions and low quality of published research reports. ( 17 , 20 – 24 ) Lack of knowledge about the procedure is an anxiogenic factor widely recognized in the literature. ( 12 , 25 – 27 ) In turn, the relaxing effects of music can alleviate feelings of tension and concern, characteristic of ARCC. The role of the musical component in the body is very complex. The human body’s response mechanisms to music can be attributed to mental schemes learned throughout life, mediated by sociocultural aspects, resulting in effects on mood, emotions, stress and relaxation; the activation of neural circuits and specific neurological functions, being a stimulant of neural coherence; and the vibratory effects of music that occur at a cellular and genetic level, but are still poorly understood. ( 28 – 30 ) The combined and synergistic effect of complex interventions (CI) with a musical and educational component is still little explored in the literature. ( 31 ) As far as we know, this type of CI has not yet been tested in emergency departments. The primary objective of this study was to assess the feasibility of conducting a randomized clinical trial (RCT) to test the effectiveness of a CI called Education and Music Intervention to Reduce Anxiety (EMIRA) in an emergency unit. The secondary objectives were to estimate the potential effectiveness of EMIRA as well as patient credibility, expectations and satisfaction in relation to the intervention. Methods Study design, site and period This is a randomized, blind, pilot clinical trial. The study was carried out in the emergency unit of a public reference hospital for cardiopneumology in São Paulo, Brazil. Data collection was carried out from October 2021 to February 2022. Population, inclusion and exclusion criteria People with ACS awaiting unscheduled diagnostic or therapeutic catheterization were included. Unscheduled catheterization was defined in this study as a percutaneous procedure not scheduled on an outpatient basis and performed due to ACS diagnosis after individuals were admitted to the emergency unit. Individuals aged 18 or older, literate, hemodynamically stable with or without the use of vasoactive medications and those who were undergoing cardiac catheterization for the first time or more than a year ago were included. Individuals diagnosed with a psychiatric disorder and using mood modulators, whether prescribed or not, were not included. Individuals with hearing impairment that prevented them from listening to music within the established parameters, presented hemodynamic instability during data collection, whose therapeutic plan was modified and did not perform the procedure and those who were interrupted for any reason during the provision of the musical component of the intervention, were excluded. Sample Size The convenience sample for this study consisted of 40 participants who were randomized to the control group (CG) or intervention group (IG). As it is a pilot study, no sample size calculation was performed. Randomization and blinding A random list of participants was generated by a statistical professional by randomly drawing 25 subjects from each group without replacement to generate the order in which they would appear in Excel®. This list was delivered to an independent researcher, who prepared 55 opaque and sealed envelopes containing participants’ designation for CG or IG according to the study entry number. Upon accepting to participate in the study and according to the order of inclusion in the study, participants received a sequential number, and the envelope with the corresponding number was opened to find out the group in which they should be allocated. It was not possible to blind the study participants, given the nature of the proposed intervention. The main researcher was blind to the randomization of participants and did not apply the intervention, nor did she collect data on clinical outcomes and satisfaction. Such data were collected and tabulated by a second independent researcher. The main researcher only had access to this data after the end of data collection. Interventions Comparator Individuals who agreed to participate responded to the initial assessment and were randomized. The CG received only conventional care, which consisted of medical and nursing actions. When cardiac catheterization was indicated, individuals were informed by the doctor about the procedure, its risks and benefits, and signed the consent to undergo examination. The nursing staff provided guidelines for preparing for the exam, such as the need for fasting and trichotomy. Anxiety assessment and management are not part of the routine perioperative care of cardiac catheterization in the service. Intervention description The IG received conventional care and EMIRA, a CI developed to reduce state anxiety, blood pressure (BP), heart rate (HR), respiratory rate (RR) and chest pain intensity in people awaiting catheterization unscheduled cardiac arrest in the emergency unit. EMIRA has two therapeutic targets: lack of knowledge about the procedure and the unpleasant feeling of emotional discomfort, concern/tension related to the procedure (manuscript under assessment in another journal). The intervention was delivered to the emergency department. The educational component consisted of an educational session lasting five to ten minutes, in which the following topics were covered: procedure purpose, exam preparation, hemodynamics service room characteristics, physical sensations expected during catheterization, possible care, complications after the procedure. The musical component consisted of MusiCure® 8 Peace ( 32 ) , delivered before cardiac catheterization in a single 20-minute session, via headphones, at a volume between 60 and 70 dB, adjusted using an application called “decibel X”. Data collection For data collection, eligible individuals were identified through the institution’s electronic medical records and their medical records were analyzed to verify the study inclusion criteria by the main researcher. All individuals who met the inclusion criteria and were in the emergency department during the data collection period were approached by the main researcher and invited to participate in the study. Those who agreed signed the Informed Consent Form (ICF). The reasons for refusing to participate in the study, reasons for withdrawing, reasons for not approaching and time for recruiting the pilot study sample were collected. Data collection occurred at three moments: T1, before catheterization and offering EMIRA; T2, before catheterization and immediately after offering EMIRA; and T3, two to four hours after catheterization. Figure 1 shows the data collection flowchart. Measures Demographics and Clinical Data At T1, demographic and clinical data were obtained through chart review or self-report. The sociodemographic and clinical data of interest were: age; sex; weight; height; marital status; education; occupation; time elapsed since the onset of ACS symptoms; comorbidities; cardiovascular risk factors; medications in use, whether prescribed or not, prior to admission to the emergency department; Killip classification; ( 31 ) use of vasopressors at the time of data collection; performing angioplasty during the procedure; and type of percutaneous coronary intervention such as elective, primary, facilitated or rescue. Vital signs and chest pain intensity Vital sign data were measured using verification devices available in the emergency department at T1, T2 and T3. All devices were properly calibrated. All vital signs checks were carried out with individuals in supine position, on a stretcher, with a 30º inclination. Two consecutive measurements were always carried out, with a one-minute interval between them, and the mean of the two measurements was used for data analysis. Chest pain intensity was assessed using a verbal numerical rating scale (VNRS) ranging from zero (absence of pain) to ten (worst possible pain). ( 32 ) Anxiety Trait and state anxiety were assessed using the version of the State-Trait Anxiety Inventory (STAI) validated for use in Brazil at T1, T2 and T3. ( 33 ) This instrument consists of two anxiety scales: trait and state. The state STAI requires participants to describe how they feel “right now” in relation to 20 items presented on a 4-point Likert scale, ranging from “absolutely not” to “very much”. Similarly, in the trait STAI, participants must answer “how they generally feel” in relation to 20 items on a 4-point Likert scale, ranging from “almost never” to “almost always”. To avoid response bias, some items are presented in reverse and the scores must be reversed to calculate the score. The total score varies from 20 to 80 for each scale, with the higher the score the higher the level of anxiety. Credibility and expectations The Credibility and Expectation Scale regarding the intervention was used to assess credibility and expectation regarding EMIRA at T1. This scale was developed by the authors of this study and has evidence of content validity. ( 36 ) The scale contains five items ranging from zero to ten, with four items assessing participant credibility and one item assessing expectations. The final credibility score is given by the sum of the values recorded for credibility items (ranges from zero to 40), and the final expectation score (ranges from zero to ten) is the value recorded for the expectation item. The higher the score, the greater the credibility and the greater the positive expectation regarding EMIRA. Participant satisfaction IG participant satisfaction with EMIRA was assessed using a VNRS at T2. VNRS’s statement was “Considering that 1 is completely dissatisfied and 10 is completely satisfied, please state your satisfaction level with EMIRA”. The VNRS ranged from 1 (completely dissatisfied) to 10 (completely satisfied). The higher the score, the greater the satisfaction with EMIRA. Data analysis Sociodemographic and clinical characteristics Welch’s T, Pearson and Fisher’s exact tests were used to compare CG and IG in relation to sociodemographic and clinical characteristics at T1. Viability Feasibility was assessed through recruitment, retention, and attrition rates. The recruitment rate was determined by the ratio between the number of people who agreed to participate in the study and the number of potentially eligible people multiplied by 100, being considered satisfactory if greater than 60%. (34) The retention rate was calculated as the ratio of the number of people who completed the study and the number of people who started the study multiplied by 100, considered satisfactory if greater than 80%. (34) Finally, the attrition rate was determined by the ratio between the number of people who did not complete the study and the number of people who completed the study multiplied by 100, being considered satisfactory if it was less than 20%. ( 34 ) The reasons for refusing to participate in the study, reasons for withdrawing, reasons for not approaching were recorded and analyzed using absolute and relative frequencies. Sample recruitment time was calculated by the number of days of data collection recorded in a field diary. EMIRA effectiveness estimate The difference in the mean scores of anxiety, BP, HR, RR and chest pain intensity before (T1) and after the music intervention (T2 and T3) was calculated using the mixed effects model for repeated measures. The STAI trait comparison was analyzed using Student’s t-test to compare numerical variables between groups. Credibility, expectations and satisfaction Differences between groups in relation to credibility and expectation were calculated using the Wilcoxon-Mann-Whitney test. To analyze the correlation between satisfaction, credibility and expectations with the STAI-state score, BP, HR, RR and chest pain intensity, Pearson’s correlation coefficient was used. The significance level adopted for the analyzes was 5%. Ethical considerations The study was approved by the Research Ethics Committees of the proposing (4.804.611) and co-participating (4.863.723) institutions. Participants were informed about their freedom to refuse/withdraw from the study. Data confidentiality and information confidentiality were ensured. Results All patients (n = 47) who met the inclusion criteria were approached, of which three refused to participate in the study, justifying tiredness, fear and not having enough education to read and understand the ICF. Of those who agreed to participate in the study (n = 44), three were excluded due to changes in medical behavior, one was excluded when collecting sociodemographic data because he reported using anxiolytics daily. In the final sample, 40 participants remained. Randomization resulted in 22 participants in the CG and 18 in the IG and Fig. 2 depicts the Consolidated Standards of Reporting Trials (CONSORT) ( 35 ) flow diagram for the intervention and control groups. There was no withdrawal from participation after participant inclusion and randomization. Participant sociodemographic and clinical characteristics are described in Table 1 . Table 1 – Participant sociodemographic and clinical characteristics Variables CG IG Total Sociodemographic Mean age, (SD/ 95% IC) 61.6 (12.6/ 55.9–67.1) 59.9 (6.7/56.5–63,3) 60.8 (9.7) 0.600 a Male n (%) 16 (72.7) 12 (66.7) 28(70.0) 0.681 b Marital status n (%) 0.341 b Single 5 (22.7) 4 (22.2) 9 (22.5) Married 9 (40.9) 11 (61.1) 20 (50.0) Separated/divorced/ widower 8 (36.4) 3 (16.7) 11 (27.5) Education n (%) 0.901 c Elementary school 7 (31.8) 7 (38.9) 14 (35.0) High school 11 (50.0) 7 (38.9) 18 (45.0) Graduated 3 (13.6) 2 (11.1) 5 (12.5) Occupation 0.081 c Economically active 12 (54.5) 14 (77.8) 26 (65.0) Retired, yes 7 (31.8) 1 (5.6) 8 (20.0) Houseperson, yes 3 (13.6) 3 (16.7) 6 (15.0) Clinical Hypertension, yes 16 (72.7) 14 (77.8) 30 (75.0) 0.717 b Diabetes Mellitus, yes 12 (54.6) 4 (22.2) 16 (40.0) 0.040 b Dyslipidemia, yes 14 (63.6) 7 (38.9) 21 (52.6) 0.124 b Previous stroke, yes 4 (18.2) 0 (0.0) 4 (10.0) 0.114 C Sedentary lifestyle, yes 17 (77.3) 15 (83.3) 32 (80.0) 0.638 b Obesity, yes 4 (18.9) 4 (22.2) 8 (20.0) 0.754 b Overweight, yes 3 (13.6) 3 (16.7) 6 (15.0) 0.792 b Smoking, yes 6 (27.3) 5 (27.8) 11 (27.5) 0.972 b Medical diagnosis regarding the main complaint 0.186 b Unstable angina 9 (40.9) 4 (22.2) 13 (32.5) STEMI 6 (27.3) 3 (16.7) 9 (22.5) NSTEMI 7 (31.9) 11 (61.2) 18 (45.0) 1st catheterization, yes 9 (41.0) 14 (77.8) 23 (57.5) 0.021 b Type of treatment 0.959 b PCI, yes 11 (50.0) 9 (50.0) 20 (50.0) Surgical, yes 3 (13.6) 3 (16.7) 6 (15.0) Clinical, yes 8 (36.4) 6 (33.3) 14 (35.0) Killip * (31) 0.462 C II 11 (84.6) 14 (100.0) 25 (92.6) III 1 (7.7) 0 (0.0) 1 (3.7) Notes: a: Welch’s t-test; b: Pearson’s test; c: Fisher’s exact test; Significance level = 5%; Caption: CG: control group; IG: intervention group; STEMI: ST-segment elevation myocardial infarction; NSTEMI: non-ST-segment elevation myocardial infarction; PCI: percutaneous coronary intervention; Killip*: The Killip classification was determined for patients with acute myocardial infarction, 13 in the CG and 14 in the IG. Table 1 shows that the groups were homogeneous for most variables, except for diabetes and cardiac catheterization for the first time. Diabetes prevalence was significantly higher among participants in the CG and the proportion of individuals who underwent cardiac catheterization for the first time was higher in the IG. Regarding the drug treatment used prior to admission to the emergency department, 15% of those were not using medication. Among participants previously on drug therapy, 70% used antihypertensive drugs, 47.5% use antidyslipidemic drugs, 40% used diuretics and 27.5% used antihypoglycemic drugs. Viability All eligible individuals (n = 47) were approached during the data collection period. It took 54 days to obtain a sample of 40 participants. No participant withdrew from participating in the study. Data related to the pilot clinical trial feasibility are described in Table 2 . Table 2 Recruitment, retention and attrition rates and number of refusals to participate in the pilot clinical trial Variables N % Recruitment rate 44/47 93.6 Retention rate 40/44 90.9 Attrition rate 4/40 10.0 Refusal 3/47 6.3 Efficacy estimation: assessment of clinical outcomes The mean trait anxiety level was 47.14 ± 9.98 vs 41.22 ± 9.48 (p = 0.064) in the CG and IG, respectively. Table 3 shows the effect of EMIRA in relation to state anxiety over time in both groups. The analysis using the mixed effects model showed that there was a difference in state STAI scores over time (p = 0.003), but not in the comparison between groups (p = 0.520). Since the difference over time did not occur between T2-T1 or T3-T2, the difference is assumed to have occurred between T3 and T1. There was also no evidence of time: group interaction (p = 0.977). Table 3 Analysis of the effect of EMIRA on state anxiety level in participants in the control and intervention groups over time Group Time Mean ± SD (95%CI) Intragroup comparison p-value Control (n = 22) T1 36.5 ± 10.0 (32.4–40.6) T2 – T1 0.290 T2 33.5 ± 9.2 (29.7–37.2) T3 – T2 0.513 T3 31.3 ± 8.5 (28.1–35.0) Intervention (n = 18) T1 38.8 ± 13.6 (33.2–45.5) T2 – T1 0.235 T2 35.1 ± 10.1 (30.4–39.5) T3 – T2 0.580 T3 32.9 ± 12.9 (29.0-42.5) Significance level = 5%; Mixed Effects Model Caption: SD: standard deviation; CI: confidence interval. Table 4 shows the effect of EMIRA in relation to chest pain intensity over time. The mixed effects model showed no difference in pain scores over time (p = 0.424) and between groups (p = 0.875). There was no evidence of time: group interaction (p = 0.832). Table 4 Analysis of the effect of EMIRA in relation to the intensity of chest pain in participants in the control and intervention groups over time Variable Group Time Mean ± SD (95%CI) Intragroup comparison p-value PAIN Control (n = 22) T1 0.5 ± 1.2 (0.2–1.3) T2 – T1 0.900 T2 0.3 ± 0.7 (0.1–0.8) T3 – T2 0.729 T3 0.6 ± 2.1 (0.1–2.6) Intervention (n = 18) T1 0.7 ± 1.9 (0.1–2.4) T2 – T1 0.406 T2 0.1 ± 0.3 (0.0–0.3) T3 – T2 0.538 T3 0.6 ± 2.3 (0.0–3.0) Significance level = 5%; Mixed Effects Model Caption: SD: standard deviation; CI: confidence interval. Regarding vital signs, the mixed effects model showed no difference in relation to SBP (time- p = 0.1001; group- p = 0.827; time: group- p = 0.952). There was a difference in DBP over time (p = 0.043), but not in the comparison between groups (p = 0.579) and in the time and group interaction (p = 0.596). Regarding HR, there was also a difference over time (p < 0.001), but it was not observed in the comparison between groups (p = 0.334) and time: group (p = 0.420). Regarding RR, there was also a difference over time (p < 0.001), but no difference was observed when comparing groups (p = 0.373) and time: group (p = 0.286), as shown in Table 5 . Table 5 Analysis of the effect of EMIRA in relation to vital signs of participants in the control and intervention groups over time Variable Group Time Mean ± SD (95%CI) Intragroup comp.* p-value SBP Control (n = 22) T1 124.3 ± 24.9(117.7-132.4) T2 – T1 0.131 T2 119.6 ± 24.0(112.9-126.9) T3 – T2 0.487 T3 122.3 ± 23.9(115.9-129.9) Intervention (n = 18) T1 122.2 ± 20.7(115.9-129.3) T2 – T1 0.363 T2 118.7 ± 15.6(113.9-124.1) T3 – T2 0.595 T3 121.2 ± 19.1(115.2-127.6) DBP Control (n = 22) T1 71.6 ± 17.4 (67.2–77.6) T2 – T1 0.310 T2 69.3 ± 15.4 (65.0-74.1) T3 – T2 0.061 T3 73.0 ± 14.7 (68.8–77.5) Intervention (n = 18) T1 72.5 ± 14.3 (67.9–77.2) T2 – T1 0.981 T2 72.8 ± 12.0 (69.1–76.9) T3 – T2 0.291 T3 75.4 ± 14.5 (70.5–79.9) HR Control (n = 22) T1 66.4 ± 14.5 (62.8–71.4) T2 – T1 0.999 T2 66.5 ± 12.0 (63.4–70.5) T3 – T2 0.043 T3 69.6 ± 14.2 (65.7–74.0) Intervention (n = 18) T1 72.1 ± 24.8 (65.4–81.8) T2 – T1 0.474 T2 70.5 ± 22.1 (64.6–79.3) T3 – T2 < 0.001 T3 76.3 ± 22.8 (70.0–85.0) RR Control (n = 22) T1 14.0 ± 2.3 (13.4–14.8) T2 – T1 0.001 T2 15.9 ± 2.9 (15.1–16.8) T3 – T2 0.324 T3 15.3 ± 2.6 (14.6–16.1) Intervention (n = 18) T1 15.2 ± 3.2 (14.4–16.5) T2 – T1 0.087 T2 16.3 ± 3.7 (15.2–17.6) T3 – T2 0.108 T3 15.3 ± 2.6 (14.5–16.2) Significance level = 5%; Mixed effects model; Caption: SD: standard deviation; CI: confidence interval; SBP: systolic blood pressure; DBP: diastolic blood pressure; HR: heart rate; RR: respiratory rate; Comp.*= comparison. Credibility, expectations and satisfaction The mean credibility scores (CG = 36.4 ± 4.6 vs IG = 34.4 ± 6.3; p = 0.347) and expectation (CG = 9.1 ± 1.3 vs IG = 8.6 ± 2 .2; p = 0.538) were high. Both groups were similar in terms of positive attitude towards the intervention. The mean satisfaction score in IG was 9.2 ± 1.1. There was no significant correlation between credibility and expectation with outcome variables (STAI state, BP, HR, RR and chest pain intensity) in IG. However, there was a negative correlation between satisfaction and SBP from T1-T2 (r= -0.624 p = 0.006), suggesting that the greater the satisfaction, the greater the decrease in SBP between T1 and T2. Discussion This study analyzed the feasibility and potential effectiveness of a CI for managing anxiety, physiological parameters and chest pain intensity in individuals with ACS awaiting unscheduled catheterization in the emergency department. The feasibility of conducting a RCT was assessed by through recruitment, retention, attrition rates, credibility, expectation and satisfaction.CI application to manage psycho-emotional symptoms in highly specialized services is still a challenge. ( 36 , 37 ) However, comprehensive care intervention application, which consider all dimensions of individuals, has shown positive results. ( 38 , 39 ) Participant sociodemographic profile in this study was similar to a study carried out in Brazil in an emergency unit. ( 40 ) In the world population as well as in the present study a higher prevalence of males was also observed in individuals with ACS. ( 41 – 43 ) Participants in this study had low education, with a predominance of elementary school. The literature shows an association between low socioeconomic status and low education with greater morbidity in cardiovascular diseases. ( 44 , 45 ) Regarding ACS clinical and electrocardiographic presentation, NSTEMI was the most observed in this study. In the literature, STEMI incidence is also higher, regardless of gender. In the United States, this type of acute myocardial infarction (AMI) accounts for 70% of ACS cases. ( 45 – 47 ) Retrospective, multicenter study compared male patients vs. female in terms of baseline characteristics, coronary findings and in-hospital and long-term prognosis and showed 79.9% of female patients with NSTEMI, while in males this number was 71.5% (p < 0.0001). (48) This study included participants who had already experienced cardiac catheterization, i.e., a repeat procedure, and participants who were having this experience in an unprecedented way. The inclusion of these two participant profiles in the sample may have influenced EMIRA results. EMIRA may or may not be effective due to its effect on anxiety, or because the groups differed in relation to a potentially anxiogenic factor, the cardiac catheterization itself. A study whose objective was to determine whether there were differences in terms of anxiety and well-being between individuals undergoing percutaneous coronary intervention (PCI) for the first time and those undergoing repeat PCI showed no statistical difference between the two groups. ( 49 ) The data suggests that conducting a larger-scale clinical trial to test the effectiveness of EMIRA is feasible. Recruitment and retention rates were high and attrition rate was low, and data collection time was less than two months. Other researchers have also investigated the feasibility of music interventions and educational interventions in other settings and found satisfactory responses. ( 50 – 52 ) Regarding the estimated effectiveness of EMIRA in this pilot study, the IG showed a greater reduction in the anxiety score than the CG between T1 and T2 (-3 vs -3.7), but the difference between the groups was not significant. A significant decrease in the state anxiety score was observed in IG and CG between T1 and T3 (-5.9 vs -5.2, respectively). However, it is not possible to state that the effect of reducing state anxiety is attributed to EMIRA, as both groups showed an improvement in the outcomes analyzed at T3 after catheterization. As observed in other studies, it is possible that reduced state anxiety in both groups was caused by cardiac catheterization between T2 and T3. ( 20 , 21 ) Researchers assessed the effect of musical intervention on anxiety and stress responses in patients undergoing cardiac catheterization. ( 53 ) RCT that assessed the effectiveness of the musical intervention in terms of anxiety, cortisol level and HR variability showed evidence of a reduction in anxiety and stress response of the musical intervention preceding cardiac catheterization, indicating that this intervention should be considered. Anxiety was also assessed by STAI (F = 31.42, p < 0.001). ( 53 ) Literature review showed different psychological preparation strategies and relaxation techniques that have been tested to reduce anxiety, stabilize physiological parameters and reduce pain intensity. ( 25 ) Education regarding the procedure was observed in 11 of the 29 studies analyzed and was effective in reducing anxiety. ( 25 ) Biofeedback, therapeutic touch and massage techniques also appeared to be effective in reducing anxiety, but not in reducing pain. ( 25 ) A quasi-experimental study that assessed the effectiveness of a video-based educational intervention on anxiety levels in patients undergoing PCI showed that IG patients experienced a tendency towards reduced anxiety after PCI. ( 54 ) However, another RCT analyzed the effectiveness of an educational intervention using an informative manual in reducing anxiety, stress and changes in vital signs in patients awaiting cardiac catheterization and showed no impact on reducing anxiety and stress. ( 22 ) A cohort that assessed patient characteristics associated with increased anxiety also showed a higher anxiety score before the procedure, in addition to the association with age < 65 years, being female, less education and undergoing primary PCI. ( 7 ) In line with these findings, a decrease in anxiety level after an invasive procedure was also observed in the present study. In relation to vital signs (BP, HR and RR) and chest pain intensity to the effect of EMIRA, there was a difference in the means of diastolic BP, HR and RR over time in the two groups. The evidence available in systematic reviews of studies that assessed music to reduce anxiety in individuals undergoing cardiac catheterization was not conclusive in relation to vital signs and pain intensity. ( 20 , 21 ) Mean credibility and expectation scores were high, which suggests that participants believed that EMIRA would help reduce state anxiety. Assessing credibility and expectations is part of acceptability of the intervention by users. ( 55 – 57 ) Credibility and expectation scores were similar between groups, which is encouraging, as participants believed that the intervention would bring results before cardiac catheterization. However, there was no significant correlation between credibility and expectations with outcome variables, suggesting that these variables probably did not influence the observed outcomes. Sidani and Braden argue that participants must consider CI as acceptable and satisfactory and that this contributes to the effectiveness of the intervention. ( 55 ) The EMIRA satisfaction score was high, suggesting that IG participants considered the intervention satisfactory. Although satisfaction with the intervention may influence the analyzed outcomes, the only significant correlation observed occurred with SBP between T1 and T2. This study has limitations that must be considered. The potentially noisy emergency department environment with limited privacy may have influenced anxiety level and EMIRA results. Measures to reduce this bias were implemented at the time of EMIRA’s applicability. Not having analyzed individuals’ prior knowledge regarding cardiac catheterization using a measuring instrument makes it difficult to establish the relationship between the effect of knowledge on reducing anxiety. Obtaining vital parameters through different multiparameter monitors was also considered a limitation. The devices undergo periodic maintenance and are analyzed by clinical engineering in terms of calibration. Furthermore, the interaction between patients and healthcare professionals during the procedure was not monitored. The effect of positive statements and medications within the catheterization room may have influenced the T3 results. Conclusions EMIRA is a unique CI consisting of an educational component and a musical component, developed to promote anxiety relief in individuals awaiting cardiac catheterization in the emergency department. Recruitment, retention and attrition rates suggest that conducting a larger scale RCT to test the effect of EMIRA on state anxiety is feasible. However, the effectiveness estimates of this pilot study do not allow us to state that EMIRA affected the analyzed outcomes (state anxiety, BP, HR, RR and chest pain intensity). EMIRA was considered satisfactory by participants and further studies should investigate its effectiveness in reducing anxiety, vital parameters and chest pain. Abbreviations CI complex intervention EMIRA Education and Music Intervention to Reduce Anxiety BP blood pressure HR heart rate RR respiratory rate IG intervention group CG control group ACS acute coronary syndrome AMI acute myocardial infarction CONSORT Consolidated Standards of Reporting Trials ICF Informed Consent Form STAI state-trait anxiety level VNRS verbal numerical rating scale RCT randomized clinical trial PCI percutaneous coronary intervention Declarations Ethics approval and consent to participate : Escola de Enfermagem da Universidade de São Paulo – EEUSP (4.804.611) and Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (4.863.723). Consent for publication : Not applicable. Availability of data and materials : Yes. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Competing interests : The authors declare that they have no competing interests. Funding : The purchase of headphones was financed by the Coordination for the Improvement of Higher Education Personnel - Brazil (CAPES) - (Coordination for the Improvement of Higher Education Personnel - Brazil (CAPES)) - Financial Code 001. Authors' contributions : Letícia de Carvalho Batista: construction, development, data collection T, read and approved the final manuscript. Milena Santos de Oliveira: data collection, read and approved the final manuscript. Juliana Paulucci Reis: data collection, read and approved the final manuscript Youri Eliphas de Almeida: data collection, read and approved the final manuscript. Rafael de Jesus Fonseca: data collection, read and approved the final manuscript. Marina de Góes Salvetti: construction, development, read and approved the final manuscript. Rita de Cassia Gengo e Silva Butcher: construction, development, read and approved the final manuscript. Acknowledgements : The Nursing Coordination of the Instituto do Coração, especially the nursing team of the Emergency unit. To the patients of the Emergency and Hemodynamics unit. This study was financed in part by the Coordination for the Improvement of Higher Education Personnel-Brazil (CAPES) – (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES)) - Finance Code 001. References Al-Hijji MA, Lennon RJ, Gulati R, El Sabbagh A, Park JY, Crusan D, et al. Safety and Risk of Major Complications With Diagnostic Cardiac Catheterization. Circ Cardiovasc Interv. 2019;12(7):e007791. Gulati M, Levy PD, Mukherjee D, Amsterdam E, Bhatt DL, Birtcher KK, AHA/ACC/ASE/CHEST et al. /SAEM/SCCT/SCMR Guideline for the Evaluation and Diagnosis of Chest Pain: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021;144(22):e368-e454. Manda YR, Baradhi KM. 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Supplementary Files CONSORTextensionPilotandFeasibilityTrialsChecklist.doc Cite Share Download PDF Status: Published Journal Publication published 22 Oct, 2025 Read the published version in Pilot and Feasibility Studies → Version 1 posted Reviewers agreed at journal 08 Apr, 2024 Reviewers invited by journal 02 Apr, 2024 Editor assigned by journal 28 Mar, 2024 First submitted to journal 27 Mar, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3877284","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":286681158,"identity":"8987abee-c182-4687-8f34-39f82013a37a","order_by":0,"name":"Letícia de Carvalho Batista","email":"data:image/png;base64,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","orcid":"https://orcid.org/0000-0003-3985-0187","institution":"USP EE: Universidade de Sao Paulo Escola de Enfermagem","correspondingAuthor":true,"prefix":"","firstName":"Letícia","middleName":"de Carvalho","lastName":"Batista","suffix":""},{"id":286681159,"identity":"e8c8f08e-2acb-4ae1-969c-56be1050877b","order_by":1,"name":"Milena Santos de Oliveira","email":"","orcid":"","institution":"Universidade Federal de São Paulo: Universidade Federal de Sao Paulo","correspondingAuthor":false,"prefix":"","firstName":"Milena","middleName":"Santos","lastName":"de Oliveira","suffix":""},{"id":286681160,"identity":"191371cd-a403-40d9-bcbf-f610e8637bd3","order_by":2,"name":"Juliana Paulucci Reis","email":"","orcid":"","institution":"ICON Clinical Research","correspondingAuthor":false,"prefix":"","firstName":"Juliana","middleName":"Paulucci","lastName":"Reis","suffix":""},{"id":286681161,"identity":"4680fa3e-bb3b-46a1-bb9c-3d413d3d073d","order_by":3,"name":"Youri Eliphas de Almeida","email":"","orcid":"","institution":"Hospital Israelita Albert Einstein: Sociedade Beneficente Israelita Brasileira Albert Einstein","correspondingAuthor":false,"prefix":"","firstName":"Youri","middleName":"Eliphas","lastName":"de Almeida","suffix":""},{"id":286681162,"identity":"3542fbc8-e17b-43c4-ac93-a91847284479","order_by":4,"name":"Rafael de Jesus Fonseca","email":"","orcid":"","institution":"Universidade de Sao Paulo","correspondingAuthor":false,"prefix":"","firstName":"Rafael","middleName":"de Jesus","lastName":"Fonseca","suffix":""},{"id":286681163,"identity":"efd8b4df-9e9b-4f09-a537-b5131ee89248","order_by":5,"name":"Marina de Góes Salvetti","email":"","orcid":"","institution":"Universidade de Sao Paulo","correspondingAuthor":false,"prefix":"","firstName":"Marina","middleName":"de Góes","lastName":"Salvetti","suffix":""},{"id":286681164,"identity":"65375f9b-be12-4a57-aaa0-d704f3429259","order_by":6,"name":"Rita de Cássia Gengo e Silva Butcher","email":"","orcid":"","institution":"FAU: Florida Atlantic University","correspondingAuthor":false,"prefix":"","firstName":"Rita","middleName":"de Cássia Gengo e Silva","lastName":"Butcher","suffix":""}],"badges":[],"createdAt":"2024-01-19 01:38:56","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3877284/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3877284/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s40814-025-01698-2","type":"published","date":"2025-10-22T16:17:20+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":54179172,"identity":"21b52690-ee05-421c-bd99-3c74b49c4ca8","added_by":"auto","created_at":"2024-04-05 16:17:02","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":598003,"visible":true,"origin":"","legend":"\u003cp\u003eData collection flowchart\u003c/p\u003e\n\u003cp\u003eCaption: ICF: Informed Consent Form; STAI: State-Trait Anxiety Inventory; VNRS: Visual Numeric Pain Scale; BP: Blood Pressure; RR: Respiratory Rate; HR: Heart Rate; EMIRA: Education and Music Intervention to Reduce Anxiety; IG: Intervention Group\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-3877284/v1/d9eca87159f474315e785527.jpeg"},{"id":54179171,"identity":"d439a9fb-dc9c-4b3a-84c1-f4fc1e3bab6b","added_by":"auto","created_at":"2024-04-05 16:17:02","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":441750,"visible":true,"origin":"","legend":"\u003cp\u003eParticipant selection flowchart\u003c/p\u003e\n\u003cp\u003eSource: Author.\u003c/p\u003e\n\u003cp\u003eEMIRA: Education and Music Intervention to Reduce Anxiety.\u003c/p\u003e","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-3877284/v1/82fea0960382685fcdc11c99.jpeg"},{"id":94490378,"identity":"6998d2ca-e547-408f-b33c-f8fb60ca4c19","added_by":"auto","created_at":"2025-10-27 17:09:31","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2313870,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3877284/v1/7eabf9cf-5952-4b1a-930b-7c33c22c77ed.pdf"},{"id":54179173,"identity":"82f8f124-46be-48a6-9512-b8d6fbbf2389","added_by":"auto","created_at":"2024-04-05 16:17:03","extension":"doc","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":233472,"visible":true,"origin":"","legend":"","description":"","filename":"CONSORTextensionPilotandFeasibilityTrialsChecklist.doc","url":"https://assets-eu.researchsquare.com/files/rs-3877284/v1/130339a82307cd1df7052d11.doc"}],"financialInterests":"","formattedTitle":"Education and Music Intervention to Reduce Anxiety: feasibility, potential efficacy and patient satisfaction in a pilot study","fulltext":[{"header":"Key messages regarding feasibility","content":"\u003cp\u003e1) What uncertainties existed regarding the feasibility?\u003c/p\u003e\n\u003cp\u003eBefore this study, the feasibility of a complex intervention consisting of an educational and musical component in patients undergoing unscheduled cardiac catheterization in the emergency department was unknown.\u003c/p\u003e\n\u003cp\u003e2) What are the key feasibility findings?\u003c/p\u003e\n\u003cp\u003eEMIRA was a no-dropout intervention, with high recruitment and retention rates, short recruitment time and low attrition rate. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e3) What are the implications of the feasibility findings for the design of the main study?\u003c/p\u003e\n\u003cp\u003eThe results of this pilot study provide evidence that a larger randomized clinical trial testing EMIRA is feasible in the emergency department. Future studies should test the effectiveness and feasibility of EMIRA in other clinical units.\u003c/p\u003e"},{"header":"Background","content":"\u003cp\u003eCardiac catheterization is the procedure of choice for risk stratification and treatment of acute coronary syndrome (ACS).\u003csup\u003e(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e, \u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/sup\u003e It is one of the most performed procedures in the world, with a risk of serious complications and mortality is less than 1%.\u003csup\u003e(1, 3)\u003c/sup\u003e Although cardiac catheterization is routinely performed in specialized hospitals, it is often unknown to patients and can exacerbate symptoms of anxiety.\u003csup\u003e(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eAnxiety related to cardiac catheterization (ARCC) can be defined as an unpleasant feeling of worry, concern and/or nervousness characterized as an adaptive phenomenon associated with cardiac catheterization, pain, hospitalization, fear, lack of knowledge or uncertainty.\u003csup\u003e(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/sup\u003e This is a highly prevalent phenomenon in the perioperative period of cardiac catheterization.\u003csup\u003e(\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/sup\u003e In fact, ARCC incidence is highest in the 24 hours preceding the procedure, affecting between 61% and 90% of patients awaiting the procedure. \u003csup\u003e(\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/sup\u003e ARCC has been associated with higher rates of complications both during the procedure and in the subsequent months.\u003csup\u003e(\u003cspan additionalcitationids=\"CR9 CR10 CR11 CR12 CR13 CR14 CR15\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e)\u003c/sup\u003e Therefore, the preoperative period seems to be the ideal time to apply interventions aimed at managing ARCC.\u003csup\u003e(\u003cspan additionalcitationids=\"CR9 CR10 CR11 CR12 CR13 CR14 CR15\" citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eSeveral non-pharmacological interventions have been tested for managing ARCC and other manifestations of anxiety, such as changes in vital parameters. Interventions with music and educational interventions, applied in isolation, are among the most studied as they are considered safe, cheap and easy to administer.\u003csup\u003e(\u003cspan additionalcitationids=\"CR18\" citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e)\u003c/sup\u003e However, the literature on the effect of music and educational interventions on reducing ARCC, blood pressure (BP), heart rate (HR) and pain is controversial, which can be explained, in part, by the heterogeneity of interventions and low quality of published research reports. \u003csup\u003e(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan additionalcitationids=\"CR21 CR22 CR23\" citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eLack of knowledge about the procedure is an anxiogenic factor widely recognized in the literature.\u003csup\u003e(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan additionalcitationids=\"CR26\" citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e)\u003c/sup\u003e In turn, the relaxing effects of music can alleviate feelings of tension and concern, characteristic of ARCC. The role of the musical component in the body is very complex. The human body\u0026rsquo;s response mechanisms to music can be attributed to mental schemes learned throughout life, mediated by sociocultural aspects, resulting in effects on mood, emotions, stress and relaxation; the activation of neural circuits and specific neurological functions, being a stimulant of neural coherence; and the vibratory effects of music that occur at a cellular and genetic level, but are still poorly understood.\u003csup\u003e(\u003cspan additionalcitationids=\"CR29\" citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe combined and synergistic effect of complex interventions (CI) with a musical and educational component is still little explored in the literature.\u003csup\u003e(\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e)\u003c/sup\u003e As far as we know, this type of CI has not yet been tested in emergency departments. The primary objective of this study was to assess the feasibility of conducting a randomized clinical trial (RCT) to test the effectiveness of a CI called Education and Music Intervention to Reduce Anxiety (EMIRA) in an emergency unit. The secondary objectives were to estimate the potential effectiveness of EMIRA as well as patient credibility, expectations and satisfaction in relation to the intervention.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy design, site and period\u003c/h2\u003e \u003cp\u003eThis is a randomized, blind, pilot clinical trial. The study was carried out in the emergency unit of a public reference hospital for cardiopneumology in S\u0026atilde;o Paulo, Brazil. Data collection was carried out from October 2021 to February 2022.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003ePopulation, inclusion and exclusion criteria\u003c/h2\u003e \u003cp\u003ePeople with ACS awaiting unscheduled diagnostic or therapeutic catheterization were included. Unscheduled catheterization was defined in this study as a percutaneous procedure not scheduled on an outpatient basis and performed due to ACS diagnosis after individuals were admitted to the emergency unit.\u003c/p\u003e \u003cp\u003eIndividuals aged 18 or older, literate, hemodynamically stable with or without the use of vasoactive medications and those who were undergoing cardiac catheterization for the first time or more than a year ago were included. Individuals diagnosed with a psychiatric disorder and using mood modulators, whether prescribed or not, were not included. Individuals with hearing impairment that prevented them from listening to music within the established parameters, presented hemodynamic instability during data collection, whose therapeutic plan was modified and did not perform the procedure and those who were interrupted for any reason during the provision of the musical component of the intervention, were excluded.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eSample Size\u003c/h2\u003e \u003cp\u003eThe convenience sample for this study consisted of 40 participants who were randomized to the control group (CG) or intervention group (IG). As it is a pilot study, no sample size calculation was performed.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eRandomization and blinding\u003c/h2\u003e \u003cp\u003eA random list of participants was generated by a statistical professional by randomly drawing 25 subjects from each group without replacement to generate the order in which they would appear in Excel\u0026reg;. This list was delivered to an independent researcher, who prepared 55 opaque and sealed envelopes containing participants\u0026rsquo; designation for CG or IG according to the study entry number. Upon accepting to participate in the study and according to the order of inclusion in the study, participants received a sequential number, and the envelope with the corresponding number was opened to find out the group in which they should be allocated.\u003c/p\u003e \u003cp\u003eIt was not possible to blind the study participants, given the nature of the proposed intervention. The main researcher was blind to the randomization of participants and did not apply the intervention, nor did she collect data on clinical outcomes and satisfaction. Such data were collected and tabulated by a second independent researcher. The main researcher only had access to this data after the end of data collection.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eInterventions\u003c/h2\u003e \u003cdiv id=\"Sec8\" class=\"Section3\"\u003e \u003ch2\u003eComparator\u003c/h2\u003e \u003cp\u003eIndividuals who agreed to participate responded to the initial assessment and were randomized. The CG received only conventional care, which consisted of medical and nursing actions. When cardiac catheterization was indicated, individuals were informed by the doctor about the procedure, its risks and benefits, and signed the consent to undergo examination. The nursing staff provided guidelines for preparing for the exam, such as the need for fasting and trichotomy. Anxiety assessment and management are not part of the routine perioperative care of cardiac catheterization in the service.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eIntervention description\u003c/h2\u003e \u003cp\u003eThe IG received conventional care and EMIRA, a CI developed to reduce state anxiety, blood pressure (BP), heart rate (HR), respiratory rate (RR) and chest pain intensity in people awaiting catheterization unscheduled cardiac arrest in the emergency unit. EMIRA has two therapeutic targets: lack of knowledge about the procedure and the unpleasant feeling of emotional discomfort, concern/tension related to the procedure (manuscript under assessment in another journal).\u003c/p\u003e \u003cp\u003eThe intervention was delivered to the emergency department. The educational component consisted of an educational session lasting five to ten minutes, in which the following topics were covered: procedure purpose, exam preparation, hemodynamics service room characteristics, physical sensations expected during catheterization, possible care, complications after the procedure. The musical component consisted of MusiCure\u0026reg; 8 Peace \u003csup\u003e(\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e)\u003c/sup\u003e, delivered before cardiac catheterization in a single 20-minute session, via headphones, at a volume between 60 and 70 dB, adjusted using an application called \u0026ldquo;decibel X\u0026rdquo;.\u003c/p\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eFor data collection, eligible individuals were identified through the institution\u0026rsquo;s electronic medical records and their medical records were analyzed to verify the study inclusion criteria by the main researcher. All individuals who met the inclusion criteria and were in the emergency department during the data collection period were approached by the main researcher and invited to participate in the study. Those who agreed signed the Informed Consent Form (ICF). The reasons for refusing to participate in the study, reasons for withdrawing, reasons for not approaching and time for recruiting the pilot study sample were collected. Data collection occurred at three moments: T1, before catheterization and offering EMIRA; T2, before catheterization and immediately after offering EMIRA; and T3, two to four hours after catheterization. Figure\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e shows the data collection flowchart.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eMeasures\u003c/h2\u003e \u003cdiv id=\"Sec12\" class=\"Section3\"\u003e \u003ch2\u003eDemographics and Clinical Data\u003c/h2\u003e \u003cp\u003eAt T1, demographic and clinical data were obtained through chart review or self-report. The sociodemographic and clinical data of interest were: age; sex; weight; height; marital status; education; occupation; time elapsed since the onset of ACS symptoms; comorbidities; cardiovascular risk factors; medications in use, whether prescribed or not, prior to admission to the emergency department; Killip classification;\u003csup\u003e(\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e)\u003c/sup\u003e use of vasopressors at the time of data collection; performing angioplasty during the procedure; and type of percutaneous coronary intervention such as elective, primary, facilitated or rescue.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eVital signs and chest pain intensity\u003c/h2\u003e \u003cp\u003eVital sign data were measured using verification devices available in the emergency department at T1, T2 and T3. All devices were properly calibrated. All vital signs checks were carried out with individuals in supine position, on a stretcher, with a 30\u0026ordm; inclination. Two consecutive measurements were always carried out, with a one-minute interval between them, and the mean of the two measurements was used for data analysis. Chest pain intensity was assessed using a verbal numerical rating scale (VNRS) ranging from zero (absence of pain) to ten (worst possible pain).\u003csup\u003e(\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eAnxiety\u003c/h2\u003e \u003cp\u003eTrait and state anxiety were assessed using the version of the State-Trait Anxiety Inventory (STAI) validated for use in Brazil at T1, T2 and T3.\u003csup\u003e(\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e)\u003c/sup\u003e This instrument consists of two anxiety scales: trait and state. The state STAI requires participants to describe how they feel \u0026ldquo;right now\u0026rdquo; in relation to 20 items presented on a 4-point Likert scale, ranging from \u0026ldquo;absolutely not\u0026rdquo; to \u0026ldquo;very much\u0026rdquo;. Similarly, in the trait STAI, participants must answer \u0026ldquo;how they generally feel\u0026rdquo; in relation to 20 items on a 4-point Likert scale, ranging from \u0026ldquo;almost never\u0026rdquo; to \u0026ldquo;almost always\u0026rdquo;. To avoid response bias, some items are presented in reverse and the scores must be reversed to calculate the score. The total score varies from 20 to 80 for each scale, with the higher the score the higher the level of anxiety.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eCredibility and expectations\u003c/h2\u003e \u003cp\u003eThe Credibility and Expectation Scale regarding the intervention was used to assess credibility and expectation regarding EMIRA at T1. This scale was developed by the authors of this study and has evidence of content validity.\u003csup\u003e(\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e)\u003c/sup\u003e The scale contains five items ranging from zero to ten, with four items assessing participant credibility and one item assessing expectations. The final credibility score is given by the sum of the values recorded for credibility items (ranges from zero to 40), and the final expectation score (ranges from zero to ten) is the value recorded for the expectation item. The higher the score, the greater the credibility and the greater the positive expectation regarding EMIRA.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eParticipant satisfaction\u003c/h2\u003e \u003cp\u003eIG participant satisfaction with EMIRA was assessed using a VNRS at T2. VNRS\u0026rsquo;s statement was \u0026ldquo;Considering that 1 is completely dissatisfied and 10 is completely satisfied, please state your satisfaction level with EMIRA\u0026rdquo;. The VNRS ranged from 1 (completely dissatisfied) to 10 (completely satisfied). The higher the score, the greater the satisfaction with EMIRA.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cdiv id=\"Sec18\" class=\"Section3\"\u003e \u003ch2\u003eSociodemographic and clinical characteristics\u003c/h2\u003e \u003cp\u003eWelch\u0026rsquo;s T, Pearson and Fisher\u0026rsquo;s exact tests were used to compare CG and IG in relation to sociodemographic and clinical characteristics at T1.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eViability\u003c/h2\u003e \u003cp\u003eFeasibility was assessed through recruitment, retention, and attrition rates. The recruitment rate was determined by the ratio between the number of people who agreed to participate in the study and the number of potentially eligible people multiplied by 100, being considered satisfactory if greater than 60%.\u003csup\u003e(34)\u003c/sup\u003e The retention rate was calculated as the ratio of the number of people who completed the study and the number of people who started the study multiplied by 100, considered satisfactory if greater than 80%.\u003csup\u003e(34)\u003c/sup\u003e Finally, the attrition rate was determined by the ratio between the number of people who did not complete the study and the number of people who completed the study multiplied by 100, being considered satisfactory if it was less than 20%. \u003csup\u003e(\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe reasons for refusing to participate in the study, reasons for withdrawing, reasons for not approaching were recorded and analyzed using absolute and relative frequencies. Sample recruitment time was calculated by the number of days of data collection recorded in a field diary.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eEMIRA effectiveness estimate\u003c/h2\u003e \u003cp\u003eThe difference in the mean scores of anxiety, BP, HR, RR and chest pain intensity before (T1) and after the music intervention (T2 and T3) was calculated using the mixed effects model for repeated measures. The STAI trait comparison was analyzed using Student\u0026rsquo;s t-test to compare numerical variables between groups.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eCredibility, expectations and satisfaction\u003c/h2\u003e \u003cp\u003eDifferences between groups in relation to credibility and expectation were calculated using the Wilcoxon-Mann-Whitney test. To analyze the correlation between satisfaction, credibility and expectations with the STAI-state score, BP, HR, RR and chest pain intensity, Pearson\u0026rsquo;s correlation coefficient was used.\u003c/p\u003e \u003cp\u003eThe significance level adopted for the analyzes was 5%.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eEthical considerations\u003c/h2\u003e \u003cp\u003e The study was approved by the Research Ethics Committees of the proposing (4.804.611) and co-participating (4.863.723) institutions. Participants were informed about their freedom to refuse/withdraw from the study. Data confidentiality and information confidentiality were ensured.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eAll patients (n\u0026thinsp;=\u0026thinsp;47) who met the inclusion criteria were approached, of which three refused to participate in the study, justifying tiredness, fear and not having enough education to read and understand the ICF. Of those who agreed to participate in the study (n\u0026thinsp;=\u0026thinsp;44), three were excluded due to changes in medical behavior, one was excluded when collecting sociodemographic data because he reported using anxiolytics daily. In the final sample, 40 participants remained. Randomization resulted in 22 participants in the CG and 18 in the IG and Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e depicts the Consolidated Standards of Reporting Trials (CONSORT)\u003csup\u003e(\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e35\u003c/span\u003e)\u003c/sup\u003e flow diagram for the intervention and control groups.\u003c/p\u003e \u003cp\u003eThere was no withdrawal from participation after participant inclusion and randomization. Participant sociodemographic and clinical characteristics are described in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003e\u0026ndash; Participant sociodemographic and clinical characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eVariables\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003eCG\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eIG\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eTotal\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"1\" nameend=\"c7\" namest=\"c7\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eSociodemographic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eMean age,\u003c/p\u003e \u003cp\u003e(SD/ 95% IC)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e61.6\u003c/p\u003e \u003cp\u003e(12.6/ 55.9\u0026ndash;67.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e59.9\u003c/p\u003e \u003cp\u003e(6.7/56.5\u0026ndash;63,3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e60.8 (9.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.600\u003csup\u003e\u003cb\u003ea\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eMale n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e16 (72.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e12 (66.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e28(70.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.681\u003csup\u003e\u003cb\u003eb\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eMarital status n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c6\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.341\u003csup\u003e\u003cb\u003eb\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eSingle\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5 (22.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e4 (22.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e9 (22.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eMarried\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9 (40.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e11 (61.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e20 (50.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eSeparated/divorced/ widower\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e8 (36.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (16.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11 (27.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eEducation n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"4\" nameend=\"c6\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.901\u003csup\u003e\u003cb\u003ec\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eElementary school\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e7 (31.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7 (38.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14 (35.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\" morerows=\"2\" rowspan=\"3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eHigh school\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e11 (50.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7 (38.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e18 (45.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eGraduated\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e3 (13.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2 (11.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e5 (12.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eOccupation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.081\u003csup\u003e\u003cb\u003ec\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eEconomically active\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e12 (54.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14 (77.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e26 (65.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eRetired, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e7 (31.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1 (5.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e8 (20.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eHouseperson, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e3 (13.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (16.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e6 (15.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e\u003cb\u003eClinical\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eHypertension, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e16 (72.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14 (77.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e30 (75.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.717 \u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eDiabetes Mellitus, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e12 (54.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4 (22.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e16 (40.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.040\u003c/b\u003e \u003csup\u003e\u003cb\u003eb\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eDyslipidemia, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e14 (63.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7 (38.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e21 (52.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.124 \u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003ePrevious stroke, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e4 (18.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4 (10.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.114 \u003csup\u003eC\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eSedentary lifestyle, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e17 (77.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e15 (83.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e32 (80.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.638 \u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eObesity, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e4 (18.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4 (22.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e8 (20.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.754 \u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eOverweight, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e3 (13.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (16.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e6 (15.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.792 \u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eSmoking, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e6 (27.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5 (27.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e11 (27.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.972 \u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"6\" nameend=\"c6\" namest=\"c1\"\u003e \u003cp\u003eMedical diagnosis regarding the main complaint\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.186 \u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eUnstable angina\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e9 (40.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4 (22.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e13 (32.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eSTEMI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e6 (27.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (16.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e9 (22.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eNSTEMI\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e7 (31.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e11 (61.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e18 (45.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003e1st catheterization, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e9 (41.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14 (77.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e23 (57.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e\u003cb\u003e0.021\u003c/b\u003e\u003csup\u003e\u003cb\u003eb\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eType of treatment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.959\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003ePCI, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e11 (50.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9 (50.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e20 (50.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eSurgical, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e3 (13.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3 (16.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e6 (15.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eClinical, yes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e8 (36.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e6 (33.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e14 (35.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eKillip\u003csup\u003e\u003cb\u003e*\u003c/b\u003e (31)\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003e0.462\u003csup\u003eC\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e11 (84.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14 (100.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e25 (92.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e \u003cp\u003eIII\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e \u003cp\u003e1 (7.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0 (0.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e1 (3.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003eNotes: a: Welch\u0026rsquo;s t-test; b: Pearson\u0026rsquo;s test; c: Fisher\u0026rsquo;s exact test; Significance level\u0026thinsp;=\u0026thinsp;5%;\u003c/td\u003e\u003c/tr\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003eCaption: CG: control group; IG: intervention group; STEMI: ST-segment elevation myocardial infarction; NSTEMI: non-ST-segment elevation myocardial infarction; PCI: percutaneous coronary intervention;\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eKillip*: The Killip classification was determined for patients with acute myocardial infarction, 13 in the CG and 14 in the IG.\u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e shows that the groups were homogeneous for most variables, except for diabetes and cardiac catheterization for the first time. Diabetes prevalence was significantly higher among participants in the CG and the proportion of individuals who underwent cardiac catheterization for the first time was higher in the IG. Regarding the drug treatment used prior to admission to the emergency department, 15% of those were not using medication. Among participants previously on drug therapy, 70% used antihypertensive drugs, 47.5% use antidyslipidemic drugs, 40% used diuretics and 27.5% used antihypoglycemic drugs.\u003c/p\u003e \u003cdiv id=\"Sec24\" class=\"Section2\"\u003e \u003ch2\u003eViability\u003c/h2\u003e \u003cp\u003eAll eligible individuals (n\u0026thinsp;=\u0026thinsp;47) were approached during the data collection period. It took 54 days to obtain a sample of 40 participants. No participant withdrew from participating in the study. Data related to the pilot clinical trial feasibility are described in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eRecruitment, retention and attrition rates and number of refusals to participate in the pilot clinical trial\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariables\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003e%\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRecruitment rate\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e44/47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e93.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRetention rate\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e40/44\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e90.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAttrition rate\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4/40\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRefusal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3/47\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6.3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003eEfficacy estimation: assessment of clinical outcomes\u003c/h2\u003e \u003cp\u003eThe mean trait anxiety level was 47.14\u0026thinsp;\u0026plusmn;\u0026thinsp;9.98 vs 41.22\u0026thinsp;\u0026plusmn;\u0026thinsp;9.48 (p\u0026thinsp;=\u0026thinsp;0.064) in the CG and IG, respectively.\u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e shows the effect of EMIRA in relation to state anxiety over time in both groups. The analysis using the mixed effects model showed that there was a difference in state STAI scores over time (p\u0026thinsp;=\u0026thinsp;0.003), but not in the comparison between groups (p\u0026thinsp;=\u0026thinsp;0.520). Since the difference over time did not occur between T2-T1 or T3-T2, the difference is assumed to have occurred between T3 and T1. There was also no evidence of time: group interaction (p\u0026thinsp;=\u0026thinsp;0.977).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAnalysis of the effect of EMIRA on state anxiety level in participants in the control and intervention groups over time\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTime\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMean\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;SD (95%CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eIntragroup comparison\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;22)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36.5\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;10.0 (32.4\u0026ndash;40.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.290\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e33.5\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;9.2 (29.7\u0026ndash;37.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.513\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e31.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;8.5 (28.1\u0026ndash;35.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eIntervention\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;18)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e38.8\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;13.6 (33.2\u0026ndash;45.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.235\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e35.1\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;10.1 (30.4\u0026ndash;39.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.580\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e32.9\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;12.9 (29.0-42.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"5\"\u003eSignificance level\u0026thinsp;=\u0026thinsp;5%; Mixed Effects Model\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eCaption: SD: standard deviation; CI: confidence interval.\u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e shows the effect of EMIRA in relation to chest pain intensity over time. The mixed effects model showed no difference in pain scores over time (p\u0026thinsp;=\u0026thinsp;0.424) and between groups (p\u0026thinsp;=\u0026thinsp;0.875). There was no evidence of time: group interaction (p\u0026thinsp;=\u0026thinsp;0.832).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAnalysis of the effect of EMIRA in relation to the intensity of chest pain in participants in the control and intervention groups over time\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTime\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMean\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;SD (95%CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eIntragroup comparison\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"5\" rowspan=\"6\"\u003e \u003cp\u003ePAIN\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;22)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.5\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;1.2 (0.2\u0026ndash;1.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.900\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;0.7 (0.1\u0026ndash;0.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.729\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.6\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;2.1 (0.1\u0026ndash;2.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eIntervention\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;18)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.7\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;1.9 (0.1\u0026ndash;2.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.406\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.1\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;0.3 (0.0\u0026ndash;0.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.538\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.6\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;2.3 (0.0\u0026ndash;3.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eSignificance level\u0026thinsp;=\u0026thinsp;5%; Mixed Effects Model\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eCaption: SD: standard deviation; CI: confidence interval.\u003c/p\u003e \u003cp\u003eRegarding vital signs, the mixed effects model showed no difference in relation to SBP (time- p\u0026thinsp;=\u0026thinsp;0.1001; group- p\u0026thinsp;=\u0026thinsp;0.827; time: group- p\u0026thinsp;=\u0026thinsp;0.952). There was a difference in DBP over time (p\u0026thinsp;=\u0026thinsp;0.043), but not in the comparison between groups (p\u0026thinsp;=\u0026thinsp;0.579) and in the time and group interaction (p\u0026thinsp;=\u0026thinsp;0.596). Regarding HR, there was also a difference over time (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), but it was not observed in the comparison between groups (p\u0026thinsp;=\u0026thinsp;0.334) and time: group (p\u0026thinsp;=\u0026thinsp;0.420). Regarding RR, there was also a difference over time (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), but no difference was observed when comparing groups (p\u0026thinsp;=\u0026thinsp;0.373) and time: group (p\u0026thinsp;=\u0026thinsp;0.286), as shown in Table\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAnalysis of the effect of EMIRA in relation to vital signs of participants in the control and intervention groups over time\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eVariable\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGroup\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTime\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMean\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;SD (95%CI)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eIntragroup comp.*\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003ep-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"5\" rowspan=\"6\"\u003e \u003cp\u003eSBP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;22)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e124.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;24.9(117.7-132.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.131\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e119.6\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;24.0(112.9-126.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.487\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e122.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;23.9(115.9-129.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eIntervention\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;18)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e122.2\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;20.7(115.9-129.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.363\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e118.7\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;15.6(113.9-124.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.595\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e121.2\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;19.1(115.2-127.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"5\" rowspan=\"6\"\u003e \u003cp\u003eDBP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;22)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e71.6\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;17.4 (67.2\u0026ndash;77.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.310\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e69.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;15.4 (65.0-74.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.061\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e73.0\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;14.7 (68.8\u0026ndash;77.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eIntervention\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;18)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e72.5\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;14.3 (67.9\u0026ndash;77.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.981\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e72.8\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;12.0 (69.1\u0026ndash;76.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.291\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e75.4\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;14.5 (70.5\u0026ndash;79.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"5\" rowspan=\"6\"\u003e \u003cp\u003eHR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;22)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e66.4\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;14.5 (62.8\u0026ndash;71.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.999\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e66.5\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;12.0 (63.4\u0026ndash;70.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e0.043\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e69.6\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;14.2 (65.7\u0026ndash;74.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eIntervention\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;18)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e72.1\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;24.8 (65.4\u0026ndash;81.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.474\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e70.5\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;22.1 (64.6\u0026ndash;79.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e76.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;22.8 (70.0\u0026ndash;85.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"5\" rowspan=\"6\"\u003e \u003cp\u003eRR\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eControl\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;22)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e14.0\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;2.3 (13.4\u0026ndash;14.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e0.001\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15.9\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;2.9 (15.1\u0026ndash;16.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.324\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;2.6 (14.6\u0026ndash;16.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\" morerows=\"2\" rowspan=\"3\"\u003e \u003cp\u003eIntervention\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;18)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15.2\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;3.2 (14.4\u0026ndash;16.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT2 \u0026ndash; T1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.087\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e16.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;3.7 (15.2\u0026ndash;17.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eT3 \u0026ndash; T2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.108\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e15.3\u0026thinsp;\u003cspan type=\"Underline\" class=\"Underline\" name=\"Emphasis\"\u003e\u0026plusmn;\u003c/span\u003e\u0026thinsp;2.6 (14.5\u0026ndash;16.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eSignificance level\u0026thinsp;=\u0026thinsp;5%; Mixed effects model;\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eCaption: SD: standard deviation; CI: confidence interval; SBP: systolic blood pressure; DBP: diastolic blood pressure; HR: heart rate; RR: respiratory rate; Comp.*= comparison.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec26\" class=\"Section3\"\u003e \u003ch2\u003eCredibility, expectations and satisfaction\u003c/h2\u003e \u003cp\u003eThe mean credibility scores (CG\u0026thinsp;=\u0026thinsp;36.4\u0026thinsp;\u0026plusmn;\u0026thinsp;4.6 vs IG\u0026thinsp;=\u0026thinsp;34.4\u0026thinsp;\u0026plusmn;\u0026thinsp;6.3; p\u0026thinsp;=\u0026thinsp;0.347) and expectation (CG\u0026thinsp;=\u0026thinsp;9.1\u0026thinsp;\u0026plusmn;\u0026thinsp;1.3 vs IG\u0026thinsp;=\u0026thinsp;8.6\u0026thinsp;\u0026plusmn;\u0026thinsp;2 .2; p\u0026thinsp;=\u0026thinsp;0.538) were high. Both groups were similar in terms of positive attitude towards the intervention. The mean satisfaction score in IG was 9.2\u0026thinsp;\u0026plusmn;\u0026thinsp;1.1. There was no significant correlation between credibility and expectation with outcome variables (STAI state, BP, HR, RR and chest pain intensity) in IG. However, there was a negative correlation between satisfaction and SBP from T1-T2 (r= -0.624 p\u0026thinsp;=\u0026thinsp;0.006), suggesting that the greater the satisfaction, the greater the decrease in SBP between T1 and T2.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study analyzed the feasibility and potential effectiveness of a CI for managing anxiety, physiological parameters and chest pain intensity in individuals with ACS awaiting unscheduled catheterization in the emergency department. The feasibility of conducting a RCT was assessed by through recruitment, retention, attrition rates, credibility, expectation and satisfaction.CI application to manage psycho-emotional symptoms in highly specialized services is still a challenge.\u003csup\u003e(\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e, \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e)\u003c/sup\u003e However, comprehensive care intervention application, which consider all dimensions of individuals, has shown positive results.\u003csup\u003e(\u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e, \u003cspan citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eParticipant sociodemographic profile in this study was similar to a study carried out in Brazil in an emergency unit.\u003csup\u003e(\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e)\u003c/sup\u003e In the world population as well as in the present study a higher prevalence of males was also observed in individuals with ACS. \u003csup\u003e(\u003cspan additionalcitationids=\"CR42\" citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eParticipants in this study had low education, with a predominance of elementary school. The literature shows an association between low socioeconomic status and low education with greater morbidity in cardiovascular diseases. \u003csup\u003e(\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e, \u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eRegarding ACS clinical and electrocardiographic presentation, NSTEMI was the most observed in this study. In the literature, STEMI incidence is also higher, regardless of gender. In the United States, this type of acute myocardial infarction (AMI) accounts for 70% of ACS cases. \u003csup\u003e(\u003cspan additionalcitationids=\"CR46\" citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e)\u003c/sup\u003e Retrospective, multicenter study compared male patients vs. female in terms of baseline characteristics, coronary findings and in-hospital and long-term prognosis and showed 79.9% of female patients with NSTEMI, while in males this number was 71.5% (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001).\u003csup\u003e(48)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThis study included participants who had already experienced cardiac catheterization, i.e., a repeat procedure, and participants who were having this experience in an unprecedented way. The inclusion of these two participant profiles in the sample may have influenced EMIRA results. EMIRA may or may not be effective due to its effect on anxiety, or because the groups differed in relation to a potentially anxiogenic factor, the cardiac catheterization itself. A study whose objective was to determine whether there were differences in terms of anxiety and well-being between individuals undergoing percutaneous coronary intervention (PCI) for the first time and those undergoing repeat PCI showed no statistical difference between the two groups.\u003csup\u003e(\u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe data suggests that conducting a larger-scale clinical trial to test the effectiveness of EMIRA is feasible. Recruitment and retention rates were high and attrition rate was low, and data collection time was less than two months. Other researchers have also investigated the feasibility of music interventions and educational interventions in other settings and found satisfactory responses.\u003csup\u003e(\u003cspan additionalcitationids=\"CR51\" citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eRegarding the estimated effectiveness of EMIRA in this pilot study, the IG showed a greater reduction in the anxiety score than the CG between T1 and T2 (-3 vs -3.7), but the difference between the groups was not significant. A significant decrease in the state anxiety score was observed in IG and CG between T1 and T3 (-5.9 vs -5.2, respectively). However, it is not possible to state that the effect of reducing state anxiety is attributed to EMIRA, as both groups showed an improvement in the outcomes analyzed at T3 after catheterization. As observed in other studies, it is possible that reduced state anxiety in both groups was caused by cardiac catheterization between T2 and T3.\u003csup\u003e(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eResearchers assessed the effect of musical intervention on anxiety and stress responses in patients undergoing cardiac catheterization.\u003csup\u003e(\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e)\u003c/sup\u003e RCT that assessed the effectiveness of the musical intervention in terms of anxiety, cortisol level and HR variability showed evidence of a reduction in anxiety and stress response of the musical intervention preceding cardiac catheterization, indicating that this intervention should be considered. Anxiety was also assessed by STAI (F\u0026thinsp;=\u0026thinsp;31.42, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). \u003csup\u003e(\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eLiterature review showed different psychological preparation strategies and relaxation techniques that have been tested to reduce anxiety, stabilize physiological parameters and reduce pain intensity.\u003csup\u003e(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e)\u003c/sup\u003e Education regarding the procedure was observed in 11 of the 29 studies analyzed and was effective in reducing anxiety.\u003csup\u003e(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e)\u003c/sup\u003e Biofeedback, therapeutic touch and massage techniques also appeared to be effective in reducing anxiety, but not in reducing pain. \u003csup\u003e(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eA quasi-experimental study that assessed the effectiveness of a video-based educational intervention on anxiety levels in patients undergoing PCI showed that IG patients experienced a tendency towards reduced anxiety after PCI. \u003csup\u003e(\u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e54\u003c/span\u003e)\u003c/sup\u003e However, another RCT analyzed the effectiveness of an educational intervention using an informative manual in reducing anxiety, stress and changes in vital signs in patients awaiting cardiac catheterization and showed no impact on reducing anxiety and stress. \u003csup\u003e(\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eA cohort that assessed patient characteristics associated with increased anxiety also showed a higher anxiety score before the procedure, in addition to the association with age\u0026thinsp;\u0026lt;\u0026thinsp;65 years, being female, less education and undergoing primary PCI.\u003csup\u003e(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e)\u003c/sup\u003e In line with these findings, a decrease in anxiety level after an invasive procedure was also observed in the present study.\u003c/p\u003e \u003cp\u003eIn relation to vital signs (BP, HR and RR) and chest pain intensity to the effect of EMIRA, there was a difference in the means of diastolic BP, HR and RR over time in the two groups. The evidence available in systematic reviews of studies that assessed music to reduce anxiety in individuals undergoing cardiac catheterization was not conclusive in relation to vital signs and pain intensity. \u003csup\u003e(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eMean credibility and expectation scores were high, which suggests that participants believed that EMIRA would help reduce state anxiety. Assessing credibility and expectations is part of acceptability of the intervention by users. \u003csup\u003e(\u003cspan additionalcitationids=\"CR56\" citationid=\"CR55\" class=\"CitationRef\"\u003e55\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e)\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eCredibility and expectation scores were similar between groups, which is encouraging, as participants believed that the intervention would bring results before cardiac catheterization. However, there was no significant correlation between credibility and expectations with outcome variables, suggesting that these variables probably did not influence the observed outcomes.\u003c/p\u003e \u003cp\u003e Sidani and Braden argue that participants must consider CI as acceptable and satisfactory and that this contributes to the effectiveness of the intervention.\u003csup\u003e(\u003cspan citationid=\"CR55\" class=\"CitationRef\"\u003e55\u003c/span\u003e)\u003c/sup\u003e The EMIRA satisfaction score was high, suggesting that IG participants considered the intervention satisfactory. Although satisfaction with the intervention may influence the analyzed outcomes, the only significant correlation observed occurred with SBP between T1 and T2.\u003c/p\u003e \u003cp\u003eThis study has limitations that must be considered. The potentially noisy emergency department environment with limited privacy may have influenced anxiety level and EMIRA results. Measures to reduce this bias were implemented at the time of EMIRA\u0026rsquo;s applicability. Not having analyzed individuals\u0026rsquo; prior knowledge regarding cardiac catheterization using a measuring instrument makes it difficult to establish the relationship between the effect of knowledge on reducing anxiety. Obtaining vital parameters through different multiparameter monitors was also considered a limitation. The devices undergo periodic maintenance and are analyzed by clinical engineering in terms of calibration. Furthermore, the interaction between patients and healthcare professionals during the procedure was not monitored. The effect of positive statements and medications within the catheterization room may have influenced the T3 results.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eEMIRA is a unique CI consisting of an educational component and a musical component, developed to promote anxiety relief in individuals awaiting cardiac catheterization in the emergency department. Recruitment, retention and attrition rates suggest that conducting a larger scale RCT to test the effect of EMIRA on state anxiety is feasible. However, the effectiveness estimates of this pilot study do not allow us to state that EMIRA affected the analyzed outcomes (state anxiety, BP, HR, RR and chest pain intensity).\u003c/p\u003e \u003cp\u003eEMIRA was considered satisfactory by participants and further studies should investigate its effectiveness in reducing anxiety, vital parameters and chest pain.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ecomplex intervention\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eEMIRA\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eEducation and Music Intervention to Reduce Anxiety\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eBP\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eblood pressure\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eHR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eheart rate\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRR\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003erespiratory rate\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eIG\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eintervention group\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCG\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003econtrol group\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eACS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eacute coronary syndrome\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eAMI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eacute myocardial infarction\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCONSORT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eConsolidated Standards of Reporting Trials\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eICF\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eInformed Consent Form\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSTAI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003estate-trait anxiety level\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eVNRS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003everbal numerical rating scale\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRCT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003erandomized clinical trial\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePCI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003epercutaneous coronary intervention\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e: Escola de Enfermagem da Universidade de S\u0026atilde;o Paulo \u0026ndash; EEUSP (4.804.611) and Instituto do Cora\u0026ccedil;\u0026atilde;o do Hospital das Cl\u0026iacute;nicas da Faculdade de Medicina da Universidade de S\u0026atilde;o Paulo (4.863.723).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e: Not applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e: Yes.\u0026nbsp;The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e: The authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e: The purchase of headphones was financed by the Coordination for the Improvement of Higher Education Personnel - Brazil (CAPES) - (Coordination for the Improvement of Higher Education Personnel - Brazil (CAPES)) - Financial Code 001.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eLet\u0026iacute;cia de Carvalho Batista: construction, development, data collection T, read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003eMilena Santos de Oliveira: data collection, read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003eJuliana Paulucci Reis: data collection, read and approved the final manuscript\u003c/p\u003e\n\u003cp\u003eYouri Eliphas de Almeida: data collection, read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003eRafael de Jesus Fonseca: data collection, read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003eMarina de G\u0026oacute;es Salvetti: construction, development, read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003eRita de Cassia Gengo e Silva Butcher:\u0026nbsp;construction, development, read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe Nursing Coordination of the Instituto do Cora\u0026ccedil;\u0026atilde;o, especially the nursing team of the Emergency unit. To the patients of the Emergency and Hemodynamics unit.\u003c/p\u003e\n\u003cp\u003eThis study was financed in part by the Coordination for the Improvement of Higher Education Personnel-Brazil (CAPES) \u0026ndash; (Coordena\u0026ccedil;\u0026atilde;o de Aperfei\u0026ccedil;oamento de Pessoal de N\u0026iacute;vel Superior - Brasil (CAPES)) - Finance Code 001.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eAl-Hijji MA, Lennon RJ, Gulati R, El Sabbagh A, Park JY, Crusan D, et al. Safety and Risk of Major Complications With Diagnostic Cardiac Catheterization. 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Psychosoc Med. 2012;9:Doc07.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJeemon P, Reddy KS. Social determinants of cardiovascular disease outcomes in Indians. Indian J Med Res. 2010;132(5):617\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWorrall-Carter L, McEvedy S, Wilson A, Rahman MA. Gender Differences in Presentation, Coronary Intervention, and Outcomes of 28,985 Acute Coronary Syndrome Patients in Victoria, Australia. Womens Health Issues. 2016;26(1):14\u0026ndash;20.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePendyala LK, Torguson R, Loh JP, Kitabata H, Minha S, Badr S, et al. Comparison of adverse outcomes after contemporary percutaneous coronary intervention in women versus men with acute coronary syndrome. Am J Cardiol. 2013;111(8):1092\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSoeiro AM, Silva PGMdBe R, Bossa EAC, Biselli AS, Leal B. Prognostic Differences between Men and Women with Acute Coronary Syndrome. Data from a Brazilian Registry. Arq Bras Cardiol. 2018;111(5):648\u0026ndash;53.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLenzen MJ, Gamel CJ, Immink AW. Anxiety and well-being in first-time coronary angioplasty patients and repeaters. Eur J Cardiovasc Nurs. 2002;1(3):195\u0026ndash;201.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFallek R, Corey K, Qamar A, Vernisie SN, Hoberman A, Selwyn PA, et al. Soothing the heart with music: A feasibility study of a bedside music therapy intervention for critically ill patients in an urban hospital setting. Palliat Support Care. 2020;18(1):47\u0026ndash;54.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePorter S, McConnell T, Graham-Wisener L, Regan J, McKeown M, Kirkwood J, et al. A randomised controlled pilot and feasibility study of music therapy for improving the quality of life of hospice inpatients. BMC Palliat Care. 2018;17(1):125.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoreno-Peral P, Conejo-Cer\u0026oacute;n S, Rubio-Valera M, Fern\u0026aacute;ndez A, Navas-Campa\u0026ntilde;a D, Rodr\u0026iacute;guez-Morej\u0026oacute;n A, et al. Effectiveness of Psychological and/or Educational Interventions in the Prevention of Anxiety: A Systematic Review, Meta-analysis, and Meta-regression. JAMA Psychiatry. 2017;74(10):1021\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMoon JR, Song J, Huh J, Kang IS, Kim JH, Park SW, et al. The effects of music intervention on anxiety and stress responses in adults with CHD undergoing cardiac catheterisation. Cardiol Young. 2023;33(2):213\u0026ndash;20.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHaddad NE, Saleh MN, Eshah NF. Effectiveness of nurse-led video interventions on anxiety in patients having percutaneous coronary intervention. Int J Nurs Pract. 2018;24(4):e12645.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSidani S, Braden CJ. Design, evaluation and implementation. 1 ed. ed: John Wiley \u0026amp; Sons Ltd; 2011.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eUebelacker LA, Weinstock LM, Battle CL, Abrantes AM, Miller IW. Treatment credibility, expectancy, and preference: Prediction of treatment engagement and outcome in a randomized clinical trial of hatha yoga vs. health education as adjunct treatments for depression. J Affect Disord. 2018;238:111\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eVranceanu A-M, Bannon S, Mace R, Lester E, Meyers E, Gates M, et al. Feasibility and Efficacy of a Resiliency Intervention for the Prevention of Chronic Emotional Distress Among Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit: A Randomized Clinical Trial. JAMA Netw Open. 2020;3(10):e2020807\u0026ndash;e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Anxiety, Cardiac Catheterization, Nursing, Randomized Controlled Trial, Health Education, Acute Coronary Syndrome, Music Therapy","lastPublishedDoi":"10.21203/rs.3.rs-3877284/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3877284/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePeople undergoing cardiac catheterization experience anxiety. Musical and educational interventions have been tested separately and have been shown to reduce anxiety in this patient profile. This pilot study aimed to assess the feasibility and potential effectiveness of a complex intervention called Education and Music Intervention to Reduce Anxiety (EMIRA), in addition to participant credibility, expectations and satisfaction.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis is a randomized, blind, pilot clinical trial, carried out in an emergency department specializing in cardiology. Feasibility was assessed according to recruitment, retention, attrition and recruitment time rates. The potential for efficacy was assessed through the effect of EMIRA on state anxiety, blood pressure, heart rate, respiratory rate and chest pain intensity, comparing the intervention group (IG) and control group (CG) before (T1), immediately after (T2) and two to four hours after (T3) the intervention. To estimate participant satisfaction with the intervention, a visual numerical scale was used. Participant credibility and expectations regarding EMIRA were determined using a previously validated instrument. The significance level adopted was 5%.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA total of 47 potential participants were approached over a period of 54 days. Recruitment, retention, and attrition rates were, respectively, 93.6%, 90.9%, and 10%. No participant withdrew from continuing in the study after recruitment. No significant difference was observed between CG and IG in relation to the analyzed outcomes. The mean score for satisfaction, credibility and expectations were high. There was a negative correlation between satisfaction and the difference in SBP between T1 and T2.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEMIRA is a complex intervention with an educational and musical component. The results suggest that a larger-scale clinical trial is feasible, participants were satisfied and had positive attitudes towards the intervention. However, EMIRA did not promote a significant change in the outcomes analyzed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRBR-857nczs\u003c/p\u003e","manuscriptTitle":"Education and Music Intervention to Reduce Anxiety: feasibility, potential efficacy and patient satisfaction in a pilot study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-04-05 16:16:58","doi":"10.21203/rs.3.rs-3877284/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2024-04-08T09:38:05+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-04-02T14:14:35+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-03-28T07:53:29+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pilot and Feasibility Studies","date":"2024-03-28T01:04:19+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"2050bab6-dd6c-4d68-a0ff-3af6a9432e5e","owner":[],"postedDate":"April 5th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-10-27T16:28:42+00:00","versionOfRecord":{"articleIdentity":"rs-3877284","link":"https://doi.org/10.1186/s40814-025-01698-2","journal":{"identity":"pilot-and-feasibility-studies","isVorOnly":false,"title":"Pilot and Feasibility Studies"},"publishedOn":"2025-10-22 16:17:20","publishedOnDateReadable":"October 22nd, 2025"},"versionCreatedAt":"2024-04-05 16:16:58","video":"","vorDoi":"10.1186/s40814-025-01698-2","vorDoiUrl":"https://doi.org/10.1186/s40814-025-01698-2","workflowStages":[]},"version":"v1","identity":"rs-3877284","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3877284","identity":"rs-3877284","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}