Efficacy of the Intensive Care Unit Diary: A Mixed-Method Study Protocol

Efficacy of the Intensive Care Unit Diary: A Mixed-Method Study Protocol | 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 Study protocol Efficacy of the Intensive Care Unit Diary: A Mixed-Method Study Protocol Pilar Muñoz-Rey, Marta Romero-García, Isabel Anglès-Sabaté, Albert Ausió-Dot, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3999021/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 19 Jan, 2026 Read the published version in BMC Nursing → Version 1 posted 4 You are reading this latest preprint version Abstract Background: Multiple international studies report on the use of diaries in intensive care units. Some highlight the benefits for patients, others focus on family members, and few consider the vision of professionals. Most use quantitative methods. Limitations such as small sample sizes and short follow-up periods affect many studies. Therefore, further research with larger samples and a longer follow-up period, employing a mixed-methods approach is suggested. This protocol was designed to evaluate the efficacy of the use of intensive care unit diaries for patients and families, as well as to understand professionals’ experiences and satisfaction with intensive care unit diaries. Method/Design: Mixed-method study: a quantitative phase followed by a qualitative phase. Phase 1: Randomised, parallel, non-blinded, multicentre clinical trial, with an experimental group (diary) and a control group (no diary), to identify the efficacy of the diary in improving quality of life and preventing post-traumatic stress and anxiety/depression in patients and family. Measurement tools include the SF-36 Health Questionnaire, EIE-R scale, and HADS scale, administered 2-, 6- and 12-months post-discharge. Each group comprises 120 cases. Data analysis will use IBM-SPSS (v.24) To evaluate the satisfaction of professionals a survey will be carried out. Phase 2: Hermeneutic phenomenological study with theoretical sampling. Size of 38-72 patients/family members until theoretical data saturation is reached. Data collection from in-depth interviews and field diary 6 months after discharge. Phenomenological analysis according to Smith. Guba and Lincoln’s rigour criteria. Discussion: This research will provide knowledge regarding the benefits and limitations of the use of diaries, based on quantitative and qualitative data, and will promote reflection on their implementation, considering patients, family, and professionals. This study will provide new knowledge about the satisfaction of professionals with diary implementation. This multicentre study will provide valuable information on the contribution of diaries in clinical practice and their impact on patient recovery and the experiences of families and professionals. If the efficacy of the diary is confirmed, it will mark a significant advancement in the care of critically ill patients, contributing to the expansion of their use. Trial registration: ClinicalTrials.gov Identifier: NCT05288140. First Published: March 21, 2022. Mixed protocol intensive care unit diary nurse anxiety depression post-traumatic stress quality of life patients family BACKGROUND Being admitted to an intensive care unit (ICU) can be a stressful event for both patients and their families, leading to a high prevalence of disorders during and after hospitalisation. 1,2 Although ICU survival has increased by 18 to 46%, 3 patients who are discharged may present physical, respiratory, motor and/or muscular disorders; cognitive disorders, such as memory impairments and lack of concentration/attention; emotional disorders related to fear; and also psychiatric symptoms, such as depression, anxiety, stress, and/or post-traumatic stress syndrome (PTSD), reducing their quality of life. 1–3 One challenge that can occur after a stay in the UCI is post-intensive care syndrome (PICS). The Society of Critical Care Medicine defines PICS as the set of signs and symptoms that encompass the cognitive, psychological, and physical problems that people face after a prolonged ICU admission. 4 PICS not only affects the critically ill patient but also family members, both psychologically and socially, with symptoms such as PTSD, depression, complicated grief, and anxiety. When the person affected is a family member, the condition is called post-intensive care syndrome in families (PICS-F). 5 PICS and PICS-F have their onset when the patient is admitted to the ICU and continue after discharge—sometimes for years. This is why care of critical patients should be improved to incorporate, on the one hand, rehabilitation and, on the other, the follow-up of patients once they have been discharged from the ICU, both in the same hospital and at home. Doing so makes it possible to prevent or minimise the sequelae of their admission. 1,5 Among the measures to prevent PICS and PICS-F is the use of the ICU diary. 2,6–11 The ICU diary first emerged in the 70s from the initiative of nurses in Scandinavia. It became common practice in some European countries, although the diaries are little used in other countries around the world, especially Spanish-speaking ones. 11–13 The diary is a coherent and personal narrative of support and encouragement to patients that explains in colloquial language their health process, daily life, and behaviour during their stay in the ICU, respecting their privacy and integrity. 14 The diary is written in an empathetic and reflective style and employs therapeutic communication with a double objective, that of caring and healing. 15 The diaries are written by the patient’s family or friends and by the health care professionals involved in their care, with nurses leading the production of the diary. It is advisable to write the diary on loose leaf paper (a maximum of 20). In addition to narrative text, diaries can include photos, drawings, and/or poems. 15 A nurse writes the first entry of the diary, greeting the patient and explaining the reasons for their admission to the ICU. From this first entry and throughout the patient’s stay, successive entries are written by relatives, friends, and healthcare personnel to describe the patient’s evolution. Finally, upon discharge from the ICU, the nurse makes a final entry to conclude the narrative and say goodbye to the patient. The ICU diary has a chronological structure and involves an investment of time, with a directly proportional relationship between the expertise of the nurses and the nurse/patient ratio with the time invested in the entries. 16 In this sense, the diary is a tool for a comprehensive vision of patient- and family-centred care and is a nursing intervention that is easy to use, low-tech, and low-cost. Despite these advantages, there can be difficulties in starting and completing the diaries due to a lack of human resources and training and the excess workload that ICU nurses experience, 6,7,12,13,15 The use of diaries shows acceptance by patients, family members, and professionals, as they consider the diary to be a beneficial tool in the healing process that influences the psychological well-being of patients, family members, and professionals. 16–18 Existing research suggests that the ICU diary provides several benefits to critically ill patients. It allows them to know what happened during their stay, distinguish fact from fiction, promote memory and improve amnesia, helping them to build their own narrative of the health situation they have experienced. 6,12,14,19–26 In addition, the ICU diary can be a catalyst for dialogue to help the patient make sense of what happened and thus improve their understanding of their dreams and their perceptions of the care received. 6,27 Some authors claim that the use of diaries can reduce anxiety, scores on the Acute Physiology and Chronic Health Evaluation (APACHE II) Disease Severity Scale, and depression, promoting a higher health-related quality of life (HRQoL) after admission to the ICU. 10 However, other studies do not find significant differences in terms of anxiety or post-traumatic stress in patients who have used the diary, but find that the use of diaries is associated with a lower risk of depression and a better quality of life. 26 Some authors note that the sample size in their studies or the methods used could be the reason for the inconclusive results obtained, and therefore they recommend multicentre experimental studies with large sample sizes in order to verify their findings. 26 In terms of the benefits for families, several authors point out that the ICU diary allows family members to narrate events, express their feelings, and communicate with the person admitted to the ICU, making them feel useful. 7,8,25,28 It is a mechanism for exchanging information to access, understand, accept, and assimilate the information received about their family member’s health situation and thus share it with the rest of the family. This can help the family member become aware of the importance of their role as a caregiver, especially to later help them build their own narrative of the health situation experienced during the patient’s stay in the ICU. 6,18,19 In this sense, diaries have been identified as sources of comfort and security, supporting the bond with the critically ill patient as a person, improving communication, humanisation, and understanding of the patient’s therapeutic plan or evolution, which produces benefits for both patients and family members and humanises ICUs. 17,19,29–31 Research has also suggested that the diary can improve the well-being of the family, producing positive effects and serving as a vector that connects the patient, the family, and health professionals, helping them on the one hand, to channel the anxiety caused by having a loved one admitted to an ICU and, on the other hand, to recover psychologically after a critical health situation, reducing symptoms related to post-traumatic stress. 9 But there is also a meta-analysis that concludes that ICU diaries do not seem to have any beneficial effect on the family members of ICU patients, 26 and other studies affirm that some family members do not want to expose themselves by expressing their feelings in the diary for fear of being read. For these family members, the ICU diary can become a great challenge and source of anguish. 14 Finally, the reported benefits of the ICU diary for professionals include personal satisfaction, the feeling of performing a job differently and well, and the personal connection with the patient and the family. 25,29,32 In addition, the increase in the visibility of nursing care is evident, as it provides new knowledge about nursing actions. 14, 29,33,34 On the other hand, the literature shows that professionals associate their workload, their lack of knowledge or creativity, and the work environment as potentially distressing obstacles in the process of writing ICU diaries. 25 The literature delineates the existence of journal implementation without a systematic plan to assess its effects ( 6 , 13 , 25 ). Considerable variability exists regarding the design of the diary, language barriers, decisions about who writes in the diary, and the inclusion or exclusion of photographs in the narrative, considering the ethical and legal aspects of their utilisation ( 13 , 16 , 27 ). Also, concern arises regarding the emotional immersion of the professional and the sense of intrusion into the privacy of the patient and their family, aspects that must be taken into consideration in the execution of the journal ( 13 , 25 ). Justification ICU diaries are used internationally in ICUs as a tool to promote the recovery of patients and their families. While almost all existing research points to the benefits of using the ICU diary, the studies have limitations, such as small sample sizes and lack of control groups in quantitative studies and an overall paucity of mixed-methods research. Therefore, in multiple published articles, researchers recommend further examination of the benefits of the use of diaries in terms of post-traumatic stress, depression, anxiety, and the improvement of well-being and quality of life, both for people cared for in ICUs and for family members, conducting studies with adequate statistical power to provide more solid evidence.. 25,26 Several authors recommend applying mixed methods in order to triangulate data on the subject and to be able to understand the lived experience of all participant types (patient, family member, professional) before implementing diaries routinely. 6,12,13,25 OBJECTIVES To assess the impact of the use of a diary for patients admitted to an ICU and their family members in terms of health-related quality of life, post-traumatic stress, and anxiety/depression at 2, 6 and 12 months after discharge from the ICU. To understand the experience of patients and their family members in using the diary and to assess the satisfaction of the nurses who lead the practice of the ICU diary. METHODS Design This parallel, open-label, non-blinded, multicentre, mixed-method study will be conducted in two phases, a quantitative phase followed by a qualitative phase. To achieve the first objective, a quantitative design will be used through a randomised clinical trial with an experimental group and a control group. To achieve the second objective, a hermeneutical phenomenological study according to Heidegger (1990) will be carried out in a constructivist paradigm (Guba and Lincoln). 35,36 PHASE 1 Scope of study The scope of study is the adult ICUs of national hospitals in Spain. Each participating ICU has a principal investigator who coordinates the project at their hospital. The selection of participating hospitals is made through an appeal to Spanish ICUs from the Spanish Society of Intensive Care Nursing and Intensive Care Units. The society’s endorsement is requested, and the interested ICUs are then contacted. Study Population and Sample The study population is all patients admitted to the participating ICUs and their family representatives from January 2023 to December 2024. The sample size was calculated considering the average number of patients admitted to Spanish ICUs and the results of previous studies. We determined the sample size using the Argimon table 37 to compare two proportions, accepting a risk α of 0.05 and a risk β of 0.2 in a bilateral contrast in independent variables, 120 subjects in the experimental group and 120 in the control group are needed to detect a difference between two proportions as statistically significant. This is expected to be 0.30 for the experimental group and 0.15 for the control group. For each of the hospitals, the necessary sample size is determined based on the annual admissions of each participating ICU. Patients who meet the following criteria are included in the study: Inclusion criteria: -Minimum ICU stay of 72 hours -Sedated with orotracheal intubation and connected to invasive mechanical ventilation for a minimum of 24 hours - Willingness of the family. Signed informed consent to participate in the study -Patients and family members who can speak, read, and write in Catalan or Spanish Exclusion criteria: -History of psychiatric or mental problems -Cognitive alterations recorded in the patient’s medical history -Have suffered serious trauma in the last year Withdrawal criteria during the study: -Death of the patient during the ICU stay or the duration of the study - Revocation of informed consent by the family member or the patient -Discharge from the ICU to another hospital -Failure to attend scheduled visits 2, 6 and 12 months after discharge As for family members , a reference family member for each critical patient who has a close and personal relationship with the patient will be selected to participate in the study. A non-probabilistic random sampling will be carried out by consecutive recruitment until the sample size is complete. A randomisation table will be used to assign patients to the experimental group or the control group. Intervention Control group: application of the usual practice of the ICU, with daily information about the events in the ICU and the patient’s evolution and condition, provided orally. Experimental group: The usual practice, plus an ICU diary will be kept by family members and health personnel. The diary consists of a ringed binder, A4 size, white, washable, and reusable. The elements comprising the diary are the front cover, back cover, glossary, and blank sheets for writing. Each patient's diary is provided by the principal investigator (PI) of the study to each participating centre. This diary includes information about the patient’s physical condition, procedures and treatments, and significant events that occurred inside and outside the unit. Photographs of the patient are not included. Health care professionals receive the “guidelines for writing the diary (for professionals)” and the family members receive the “guidelines for writing the diary (for family members)”, written by the research team. Before starting the study, the PI at each centre conducts a training session for ICU professionals on the use of diaries. The audiovisual material necessary to carry out this training is provided by the PI of the study. Both the experimental group and the control group undergo three follow-up visits as part of the study, scheduled for 2, 6 and 12 months after discharge. At these visits, the questionnaires are administered to both the patient and the family member. The first visit takes place in person, and subsequent visits are carried out online. Study variables The independent variable is use of the ICU diary . A nurse and/or the family member writes a diary entry at the time of ICU admission. This variable is dichotomous (yes / no). The dependent variables are: Health-related quality of life (HRQoL). The WHO (1994) defined quality of life as an individual’s perception of their position in life in the context of the culture and value system in which they live and in relation to their goals, expectations, standards, and concerns. The WHOQOL 38 Group established a series of points accepted by various groups of researchers in relation to HRQoL measures, among which they highlight that they must be subjective, multidimensional, include positive and negative feelings, and record variability over time. Post-traumatic stress. Post-traumatic stress disorder (PTSD) is a debilitating condition that can occur after experiencing a traumatic event and is defined as feelings of horror and hopelessness linked to something we see, hear, or experience. 39,40 Anxiety/depression. Depression is a mood disorder—transitory or permanent—characterised by feelings of dejection, unhappiness, and guilt, as well as causing a total or partial inability to enjoy everyday life. Depressive disorders can be accompanied by anxiety. 41 Secondary variables: First of all, we will collect the variables related to the patient’s sociodemographic data: Date and time of admission and discharge, age (reflected in age in years at the time the study begins), sex (male, female), main relationship between patient and family representative (partner, father-mother, child, grandfather-grandmother, friend, grandchild, sibling, brother-in-law, daughter-in-law, uncle, nephew, other), educational level (no studies, compulsory primary education, compulsory secondary education, baccalaureate, unified polyvalent baccalaureate [secondary school in the previous education system], university orientation course [post-secondary university-preparatory course, in the previous education system], professional modules, vocational training, bachelor’s degree, master's degree, doctorate) and finally, whether or not they have had an experience with an ICU previously, for both the patient and the family member. Second, the variables related to the patient’s clinical data: Variables at admission: -Admission (urgent, scheduled), type of admission (procedures, medical or trauma, elective surgery, urgent surgery), origin of admission (emergency department, operating room, emergency medical services, hospitalisation, another hospital), reason for admission (respiratory, traumatological, cardiac, neurological, infectious, renal, hepatic, coronary, immunological, urinary, digestive, other). -APACHE II (Acute Physiology and Chronic Health Evaluation) Disease Severity Scale. This is a system of classification of disease severity. It is applied in the first 24 hours of the patient’s admission to the ICU. Values range from 0 (not severe) to 67 (maximum severity and highest risk of death). Variables at discharge: -Number of hours with invasive mechanical ventilation expressed in hours and minutes (orotracheal intubation, tracheostomy, without mechanical ventilation). -Onset of impaired consciousness expressed in day, month, year, hours, and minutes. We understand sedation to be when the patient is administered the first dose of sedation, either via bolus or infusion, and their level of consciousness decreases. We will specify the type of sedation used (active ingredient) and the hours of sedation (hh.mm). -Return of normal consciousness, expressed in day, month and year, hours, and minutes and understood as the moment in which the patient presents a RASS (Richmond Agitation-Sedation Scales) of -1 and a GLASGOW (Glasgow Coma Scale) of 11 maintained for 24 consecutive hours. The RASS is a scale used to assess the degree of sedation and agitation of a patient in ICUs. The score ranges from -5 to +4, with -5 being very deep sedation and +4 being a combative state. A RASS of -1 is a drowsy state where the patient is not fully alert but stays awake (opens eyes/gazes in the direction of a voice ≥10 seconds). The GLASGOW scale is a scale to assess the level of alertness. The scale is composed of the exploration and quantification of three parameters: eye opening, verbal response, and motor response. The total score is the result of the sum of the three parameters. It ranges from 3 to 15, with 3 being the lowest value and 15 being the highest. Finally, the variables related to the professionals: sociodemographic (age, sex, years of experience, type of contract, and position), participation in the preparation of the diary (yes/no), reasons for non-completion, difficulties encountered, benefits (for patient, family member, and professional), and degree of satisfaction (using a Likert scale of 4 response options ranging from dissatisfied to highly satisfied). These variables will be collected by the research team during the patient’s stay in the ICU. A specific data collection sheet has been designed for the collection of variables on admission and another for the collection of variables at discharge. Subsequently, these variables will be entered into the database provided by the study PI. Instruments H ealth-related quality of life (HRQoL) will be evaluated using the SF-36 Health Questionnaire (Spanish adaptation), 39 which provides a profile of health status. It is a self-administered questionnaire that is completed in 5-10 minutes and consists of 36 items. The final questionnaire covers eight subscales, which represent the health concepts most frequently used in the main health questionnaires: physical functioning, social functioning, role (physical), role (emotional), mental health, vitality, bodily pain, and general health. It specifies two components: physical component score (PCS, range: 0-100) and mental component score (MCS, range: 0-100). The score ranges from 0 to 100, with a mean of 50 and a standard deviation of 10. Regarding the questionnaire’s psychometric properties, the scales show good internal consistency, starting with Chronbach’s alpha, which obtains values above 0.70 in all scales except for social function (0.69). It presents good temporal stability based on the intraclass correlation index, with values ranging from 0.58 on the emotional role scale to 0.99 on the physical role scale. 42 PTSD will be assessed using the EIE-R 40 (“Escala revisada del impacto del estresor” in Spanish), the Spanish version adapted from the original Impact of Events Scale Revised. The original version of the instrument was designed by Horowitz in 1979 and revised by Weiss and Marmar in 1997. 43 It is a self-administered scale that assesses the subjective distress that accompanies and follows stressful and/or traumatic experiences. It is made up of two subscales and fifteen items, seven that assess responses related to intrusion and eight related to avoidance. Subsequently, Weiss and Marmar’s group developed seven additional items, six aimed at the hyperarousal subscale and one more for the intrusion subscale. Each of the 22 items is weighted on a Likert-type scale intervals, with values of 0 (not at all), 1 (rarely), 3 (sometimes) and 5 (often). (Range: 0-88). Reliability studies provided good internal consistency determined by a Chronbach’s alpha index of 0.86 for the total scale, 0.78 for the intrusion subscale, and 0.82 for the avoidance subscale. 43 The two subscales have a significant correlation ( r =0.42). In test-retest studies at one-week intervals, the coefficients were 0.87 for the total scale, 0.89 for the intrusion subscale, and 0.79 for the avoidance scale. In terms of convergent validity, the scale is associated with other measures of chronic stress including somatic complaints, problems with concentration and interpersonal relationships, depression, anxiety, anger, fear, alienation, and other physiological states. An xiety/depression will be assessed using the Hospital Anxiety and Depression Scale (HADS), designed by Zigmond and Snaith 41 in 1982 in English and adapted/validated in Spanish. 44,45 The scale, designed to identify the possibility or probability of anxiety disorders and depression in patients admitted to non-psychiatric clinics, is made up of two factors, anxiety (HADS-A) and depression (HADS-D). Each of the factors has seven items that correspond to a particular mood, followed by four possible indicators of how often the respondent has experienced this feeling in the previous week. Each item generates 0 to 3 points. Odd-numbered items refer to anxiety, and even-numbered items refer to depression. The calculation of the final value is carried out independently for each factor, obtaining two measurement parameters (range: 0-21). Scores of 8-10 suggest the likely presence of signs of depression/anxiety and scores above 15 imply severe affective disorders. Factor structure has been examined in 19 studies, showing a structure of two, three or four factors. The two-factor structure was stable in the different age and gender groups. A positive correlation was observed between the two factors (Pearson 0.49-0.74). The internal consistency of the scale, determined by the Chronbach’s alpha index, varies in the HADS-A subscale from 0.68 to 0.93 (mean 0.83) and in HADS-D from 0.67 to 0.390 (mean 0.82) 45 with a cut-off point of 8 for the two subscales. The sensitivity and specificity of both is close to 0.80. It shows concurrent validity with the Becks Depression Inventory BDI (0.62-0.73 for HADS-D, 0.61-0.83 for HADS-A and 0.73 for the total scale). It has also been evaluated with the General Health Questionnaire (GHQ-28), and Clinical Anxiety Scale, Spielberg's State-Trait Inventory (STAI), with adequate correlations. These questionnaires will be administered to the patient and family representative at each of the post-discharge visits (at 2, 6, and 12 months). The approximate time taken to complete the questionnaires is 10 min. The answers to the questionnaires will be transferred by the PI at each centre to the database that will be provided, and the study PI study will interpret the results. Data collection procedure From the start date of the study, all patients admitted to the ICU who meet the inclusion/exclusion criteria of the study will be invited to participate. The family representative will be contacted and, after an explanation of the study, will be offered the opportunity to participate. If they agree to participate, the study information sheet will be provided and informed consent will be requested. The completion of the study entry registration sheet will begin, and the patient will be assigned to the experimental or control group, according to a previously designed randomisation table, until the sample size is reached. The family representative will be informed of the assigned group and those who are assigned to the experimental group will be given the guidelines on writing an ICU diary for a relative. Likewise, the nurse responsible for the patient at that time will be informed of the group assignment, so that they can start the diary or not and leave a note in the patient’s nursing record. The diary will be placed by the PI in the patient’s box, at the foot of the bed, accessible to anyone who wants to participate in writing in it during their stay in the ICU. The variable collection sheet will begin to be completed upon the patient's admission. At the time of discharge, the diary will be removed and safeguarded to ensure confidentiality. Correct compliance with the study entry record sheet and the variable collection sheet at the patient's admission will be ensured, and a second variable collection sheet will be initiated at the patient’s discharge. Finally, after discharge, the PI will contact the patient to explain the study again, and, if they agree, proceed to sign a confirmation of consent. The first follow-up visit, after 2 months, will be face-to-face, and the patient will be accompanied by the family representative. Both will fill out the questionnaires that assess HRQoL, stress, and anxiety/depression. The completion of the variable collection sheet for the follow-up visits will begin.After the scales have been administered, participants in the experimental group will read their ICU diary. At this point, patients will take their diary home with them. Both groups will be rescheduled at 6 months and 12 months, for a virtual visit where the three instruments will be administered again, and the experimental group will be offered the opportunity to comment on the content of the diary if they choose. Once the multicentre study is completed, the study PI will report the final data from each centre to its PI. Finally, a voluntary survey will be carried out with ICU professionals (who give their informed consent) about their opinion and degree of satisfaction with the use of the ICU diary. Pilot test A pilot test will be carried out in the sponsoring hospital with 20 patients, to test the proposed data collection procedure and to assess any difficulties of fieldwork. Subjects included in this test will not be used in the study. Data analysis: type of analysis and software The data will be processed using the IBM SPSS v.24 program, and a descriptive and inferential analysis will be performed. For the description of the sample, centralisation, and dispersion parameters (mean, median, standard deviation, and dispersion) will be used for the quantitative variables, and the results will be reported in the form of percentages and frequencies for the qualitative variables. A descriptive analysis will be carried out to determine the satisfaction of the professionals. Prior to the bivariate analysis, the normality of the sample distribution will be evaluated. Student’s t-test, chi-square statistic, and ANOVA will be applied according to the study variables, as well as other non-parametric tests depending on the normality of the sample. Finally, as this is a longitudinal study, an analysis of the variance of repeated measures will be performed. The level of significance for hypothesis testing will be p£0.05. PHASE 2 OF THE STUDY Participants The study population will be all patients and family representatives who have participated in the experimental group in the study period, according to the characteristics of the sample, of the hospital conducting the study. The characteristics of the sample will be as follows: -Has participated in the first part of the study within the experimental group -Is able to testify to their experience: ability to express their experience orally, without limitations in oral communication -Has attend and participated in follow-up visits -Has signed informed consent form The sampling will be theoretical and non-probabilistic, of maximum variation, until reaching data saturation. Eighteen patient profiles will be created by crossing the following sociodemographic parameters: age (18-40, 41-70, 71-100), sex (male/female), and education level (no formal education, primary or secondary studies, university studies). For each profile, we will include three to four patients, until reaching theoretical saturation, resulting in a final sample of between 36 and 72 patients. Collection and intervention techniques and procedure The technique used will be an in-depth interview with the patient and the family representative of the experimental group 6 months after discharge (at the second follow-up visit) with the support of the field diary. The interview will be conducted based on a script in a ward of the same hospital. An observer will be present. The estimated duration will be one hour, and the sessions will be audio-recorded and transcribed. Transcripts will be sent by email to the participants for validation. The field diary will allow researchers to collect methodological notes, theoretical notes, descriptive notes, and personal notes. Quality and rigour criteria The criteria of quality and rigour determined by Lincoln and Guba (1985) and the emerging criteria of Lincoln (1996) will be followed. 35 The strategies that will be carried out to preserve rigour are confirmation by participants, recognition of biases, triangulation of researchers for data analysis and triangulation of data (patients, family representatives, and professionals), use of theoretical sampling of participants to ensure their representativeness, detailed description of subjects, contexts and situations (transferability). Moreover, several research team members are experts in qualitative methods. The roles of the researcher and the participants are well throughout the study. Finally, a field diary will be used, in addition to the collection of data with the highest level of detail and including direct quotes. The recording of the interviews and subsequent confirmation with the patient or family member will also help to ensure that quality of the data and the interpretations and proposals that we make based on them. Analysis of information The type of phenomenological analysis proposed by Smith will be used. 46 The data for each participant will be analysed, respecting the nature of the participant, before moving on to the next case. The analysis will be carried out in seven stages: (1) reading and re-reading: first by listening to the recordings and reading transcripts to get a sense of the whole, (2) initial annotations, (3) development of emerging themes, (4) search for connections between emerging themes, (5) moving on to the next case, (6) search for patterns between cases, (7) writing. To facilitate the management of the data obtained, the qualitative analysis software QSR NVivo 12.0 will be used. DISCUSSION Keeping an ICU diary is a challenge for nurses and family members, as it is a novel intervention in many countries. This study considers the limitations and future lines recommended in previous studies. By proposing a mixed, multicentre experimental study that contemplates all the agents involved in the process (patients, family, and professionals) and considers the satisfaction of professionals, the results will provide rigorous and robust data regarding the use of ICU diaries. This study will determine the efficacy of the ICU diary in terms of HRQoL, post-traumatic stress, and anxiety/depression, for both patients and their families based on quantitative and qualitative data. Evaluating the results of their use and understanding the lived experience of using the diary will provide knowledge about their efficacy, since the results of this study will demonstrate the benefits and limitations of their use. The results of this study will give us much more definitive answers about the efficacy of the ICU diary. If the benefits suggested by prior research are confirmed, units that are already using the diaries can fine-tune their practice in response to information about specific effects. For units that have yet to fully implement the ICU diary, this outcome could encourage a fuller roll-out of the diary. LIMITATIONS This study has several potential limitations. The first is the lack of blinding of the patients, family members, nurses, and researchers. This weakness will be considered when interpreting the final results of the study. The second limitation is the fact that the scale used to assess HRQoL does not include some important health factors, such as sleep disorders, cognitive function, family function, and sexual function. Thirdly, the fact that the participating hospitals do not have experience in the preparation of the diary may make the study difficult. For this reason and to minimise the variability in the records, a training session will be carried out beforehand with the participating professionals and they will be provided with guidelines about how to keep an ICU diary. These limitations are counteracted by important strengths: This is the first mixed-methods study that evaluates the efficacy of the use of the ICU diary and the satisfaction of professionals, considering quantitative and qualitative aspects, in a multicentre, experimental study. Understanding patients’ experiences can help nurses standardise the implementation of the ICU diary, allowing comparability and, of course, providing us with valuable information regarding the perceptions, beliefs, and values associated with this nursing intervention. In this way, we can better understand how best to implement ICU diaries for maximum efficacy. Abbreviations APACHE: Acute Physiology and Chronic Health Evaluation HRQoL: Health-related quality of life EIE-R: Impact of Events Scale Revised HADS: Hospital Anxiety and Depression Scale PI: principal investigator MCS: mental component score WHO: World Health Organisation PCS: physical component score PICS: post-intensive care syndrome PICS-F: post-intensive care syndrome in families SF-36 : Short Form-36 Health Survey PTSD: post-traumatic stress disorder ICU: intensive care unit Declarations ETHICS APPROVAL AND CONSENT TO PARTICIPATE The study has the approval of all the ethics and research committees of the participating hospitals. The ethical principles of respect, beneficence, determination, and justice will be considered. The research will be carried out in accordance with the Declaration of Helsinki and the Belmont report, the Law on Patient Autonomy: Obtaining Informed Consent (Law 41/2002), Organic Law 3/2018, of 5 December, on Personal Data Protection, and the provisions of European Regulation No. 2016/679 on General Data Protection. This study has been approved by the participating hospitals. To maintain the confidentiality of participants, alphanumeric codes will be used. Only the IP will have access to the database, which will be password protected. CONSENT FOR PUBLICATION Not applicable AVAILABILITY OF DATA AND MATERIALS Not applicable COMPETING INTERESTS The authors of the study declare that they have no competing interests FUNDING This study has been funded by the Nurse and Society Foundation (PR-284/18) and the Talents Scholarship, Catalonia Foundation la Pedrera, Talents 2018. AUTHORS’ CONTRIBUTIONS PMR, MRG and PDH made substantial contributions to conceptualization and design. PMR, SAF and AHZ were involved in the acquisition of the financial support. PMR, MRG and PDH oversight and leadership responsibility for the research planning and execution. All authors were involved in drafting the manuscript or revising it critically for important intellectual content. All authors gave final approval of the version published. All authors agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. ACKNOWLEDGEMENTS We would like to thank all the patients and nurses who will participate in this study, as well as all the participating hospitals. References Andresen M, Guic E, Orellana A, Diaz MJ, Castro R. Posttraumatic stress disorder symptoms in close relatives of intensive care unit patients: Prevalence data resemble that of earthquake survivors in Chile. J Crit Care. 2015 Oct; 30(5): 1152.e7-11. Parker AM, Sricharoenchai T, Raparla S, Schneck KW, Bienvenu OJ, Needham DM. Posttraumatic stress disorder in critical illness survivors: a metaanalysis. Crit Care Med. 2015 May; 43(5):1121-9. Zimmerman JE, Kramer AA, Knaus WA. Changes in hospital mortality for United States intensive care unit admissions from 1988 to 2012. Crit Care. 2013 Apr 27; 17(2): R81. Stollings JL, Caylor MM. Postintensive care syndrome and the role of a follow-up clinic. Am J Health Syst Pharm. 2015; 72(15):1315-23. Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome–family.Crit Care Med. 2012; 40(2):618-24. Egerod I, Christensen D, Schwartz-Nielsen KH, Agård AS. Constructing the illness narrative: a grounded theory exploring patients' and relatives' use of intensive care diaries. Crit Care Med. 2011 Aug; 39(8):1922-8. Garrouste-Orgeas M, Coquet I, Périer A, Timsit JF, Pochard F, Lancrin F, et al. Impact of an intensive care unit diary on psychological distress in patients and relatives*.Crit Care Med.2012Jul;40(7):2033-40. Jones C, Bäckman C, Capuzzo M, Egerod I, Flaatten H, Granja C, et al. Intensive care diaries reduce new onset posttraumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010; 14(5):R168. Jones C, Bäckman C, Griffiths RD. Intensive care diaries and relatives' symptoms of posttraumatic stress disorder after critical illness: a pilot study. Am J Crit Care. 2012 May; 21(3):172-6. Knowles RE, Tarrier N. Evaluation of the effect of prospective patient diaries on emotional well-being in intensive care unit survivors: a randomized controlled trial. Crit Care Med. 2009 Jan; 37(1):184-91. BrandaoB, Luz M, Gusmao-Flores D. Using Qualitative Synthesis to Explore Heterogeneity of Randomized Trials on ICU Diaries. Crit Care Med. 2022 Nov 1; 50(11):1654-61. Aitken LM, Rattray J, Hull A, Kenardy JA, Le Brocque R, Ullman AJ. The use of diaries in psychological recovery from intensive care. Crit Care. 2013 Dec 18; 17(6):253. Muñoz MP, Villanueva C, Alonso S, Cuzco C, Romero-García M, Delgado-Hito MP. Uso y efectos terapéuticos de los diarios en Unidades de Cuidados Intensivos. Index Enferm [Internet]. 2020 Dic [citado 2023 May 11] ; 29( 4 ): 230-4. Egerod I, Bagger C. Patients’ experiences of intensive care diaries-A focus group study. Intensive Crit Care Nurs. 2010; 26(5):278–87. Gjengedal E, Storli SL, Holme AN, Eskerud RS. An act of caring–patient diaries in Norwegian intensive care units. Nurs Crit Care [Internet]. 2010; 15(4):176–184. Nydahl P, Knueck D, Egerod I. Extent and application of ICU diaries in Germany in 2014. Nurs Crit Care. 2015 May; 20(3):155-62. Blair KTA, Eccleston SD, Binder HM, McCarthy MS. Improving the Patient Experience by Implementing an ICU Diary for Those at Risk of Post-intensive Care Syndrome. J Patient Exp. 2017 Mar;4(1):4-9. Galazzi A, Adamini I, Bazzano G, Cancelli L, Fridh I, Laquintana D, Lusignani M, Rasero L. Intensive care unit diaries to help bereaved family members in their grieving process: a systematic review. Intensive Crit Care Nurs. 2022 Feb; 68:103121. Egerod I, Knowless A. Patients diaries: can they off psychological help.2016. Crit Care Nurs.Sep; 17 (7):883-90. Akerman E. Intensive Care Unit diàries: A critical appraisal. Intensive Crit Care Nurs. 2018; 47: 5-6. Aitken LM, Rattray J, Hull A, Kenardy JA, Le Brocque R, Ullman AJ. The use of diaries in psychological recovery from intensive care. Crit Care. 2013 Dec 18; 17(6):253. Pattison N, O'Gara G, Lucas C, Gull K, Thomas K, Dolan S. Filling the gaps: A mixed-methods study exploring the use of patient diaries in the critical care unit. Intensive Crit Care Nurs. 2019 Apr;51:27-34. Egerod I, Schwartz-Nielsen K, Hansen G, Lærkner E. The extent and application of patient diaries in Danish ICUs in 2006. Nursing in Critical Care [serial on the Internet]. (2007, May), [cited September 6, 2017]; 12(3): 159-67 Nielsen AH, Angel S, Hansen TB, Egerod I. Structure and content of diaries written by close relatives for intensive care unit patients: A narrative approach (DRIP study). J Adv Nurs. 2019 Jun;75(6):1296-1305. Barreto BB, Luz M, do Amaral Lopes SAV, Rosa RG, Gusmao-Flores D. Exploring family members' and health care professionals' perceptions on ICU diaries: a systematic review and qualitative data synthesis. Intensive Care Med. 2021 Jul;47(7):737-49. Barreto BB, Luz M, Rios MNO, Lopes AA, Gusmao-Flores D. The impact of intensive care unit diaries on patients' and relatives' outcomes: a systematic review and meta-analysis. Crit Care. 2019 Dec 16;23(1):411. Aitken LM, Rattray J, Kenardy J, Hull AM, Ullman AJ, Le Brocque R, et al. Perspectives of patients and family members regarding psychological support using intensive care diaries: An exploratory mixed methods study. J Crit Care. 2017 Apr; 38: 263-8. Glimelius Petersson C, Ringdal M, Apelqvist G, Bergbom I. Diaries and memories following an ICU stay: a 2-month follow-up study. Nurs Crit Care. 2015 May 25. Johansson M, Wahlin I, Magnusson L, Hanson E. Nursing staff’s experiences of intensive care unit diaries: a qualitative study. Nurs Crit Care. 2019; 24: 407-13, 10.1111/nicc.12416 Schofield R, Dibb B, Coles-Gale R, Jones CJ. The experience of relatives using intensive care diaries: A systematic review and qualitative synthesis. Int J Nurs Stud. 2021 Jul; 119:103927. Garrouste-Orgeas M, Périer A, Mouricou P, Grégoire C, Bruel C, Brochon S, Philippart F, Max A, Misset B. Writing in and reading ICU diaries: qualitative study of families' experience in the ICU. PLoS One. 2014 Oct 16;9(10):e110146. Hester M, Ingalls NK, Hatzfeld JJ. Perceptions of ICU Diary Utility and Feasibility in a Combat ICU. Mil Med. 2016 Aug; 181(8):895-9. Galvin IM, Leitch J, Gill R, Poser K, McKeown S. Humanization of critical care-psychological effects on healthcare professionals and relatives: a systematic review. Can J Anaesth. 2018 Dec; 65(12):1348-1371. Högvall LM, Egerod I, Herling SF, Rustøen T, Berntzen H. Finding the right words: A focus group investigation of nurses' experiences of writing diaries for intensive care patients with a poor prognosis. Aust Crit Care. 2023 Mar 16: S1036-7314(23)00029-2. Guba E, Lincoln Y. Paradigmas en competencia en la investigación cuialitativa. In: Compilación de Denman C. y Haro J.A., editor. Por los rincones Antología de métodos cualitativos en la investigación social.2002. p.113-45. Ramírez M, Cárdena M, Rodríguez S. El Dasein de los cuidados desde la fenomenología hermenéutica de Martín Heidegger. Enferm Universitaria 2015; 12 (3): 144-51. Argimon JM, Jiménez J. Métodos de investigación clínica y epidemiologíca. (3ª Ed.). Barcelona: Elservier;2010. WHOQOL GROUP (1995). The World Health Organization Quality of life assessment (WHOQOL). Position Paper from the World Health Organization. Soc. Sci. Med. Vol. 41, Nº 10, pp. 1.403-9. Alonso J, Prieto L, Antó JM. [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results]. Med Clin (Barc). 1995 May 27; 104(20):771-6. Báguena MJ, Villarroya E, Beleña A, Díaz A, Roldán C, Reig R. Propiedades psicométricas de la versión española de la escala revisada de impacto del estresor (EIE-R). Análisis y modificación de conducta. 2001;114 (27): 581-604. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. Vilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM. et al. El Cuestionario de Salud SF-36 español: una década de experiencia y nuevos desarrollos. Gac Sanit 2005 Abr; 19( 2 ): 135-50. Weiss DS, Marmar Ch, Metzler T, Ronfeldt HM. Predicting symptomatic distress in emergency services personnel. Journal of Consulting and Clinical Psychology 1995; 63: 361-8. Tejero A, Guimera E, Farre´ JM, Peri JM. Uso clínico del HAD (Hospital Anxiety and Depression Scale) en población psiquiátrica: un estudio de sensibilidad, fiabilidad y validez. Revista del Departamento Psiquiatría la Facultad Med Barcelona 1986; 12:233–8. Terol MC, López-Roig S., Rodríguez-Marín J, Martín-Aragón M, Pastor MA, Reig MT. Propiedades psicométricas de la Escala Hospitalaria de Ansiedad y Estrés (HAD) en población española. Ansiedad y Estrés 2007; 13 (2-3): 163-76. Smith JA, Flowers P, Larkin M. Interpretative Phenomenological Analysis: Theory, Method and Research. Qualitive Research in Psychology. SAGE Publications.2009;232 Additional Declarations No competing interests reported. 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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-3999021","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":276756210,"identity":"43154a8a-b711-468a-bf68-f9b10bd81dca","order_by":0,"name":"Pilar Muñoz-Rey","email":"","orcid":"","institution":"Germans Trias i Pujol Hospital","correspondingAuthor":false,"prefix":"","firstName":"Pilar","middleName":"","lastName":"Muñoz-Rey","suffix":""},{"id":276756211,"identity":"2d58aee5-9213-474d-aef9-e61c55e59562","order_by":1,"name":"Marta Romero-García","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAxElEQVRIiWNgGAWjYJADxgeMDUDqABEqG6AMZgOStbBJEKVFt/3s8wc/99hE80sfPlbNu4NBju9GAn4tZmfSDRt7nqXlzuxLS7vNe4bBWJKglgNpjA08Bw7nbjjDY3abt40hcQNBLeefMTb+AWrZD9RSDNRST1jLjTTGZrAtPDxmzEAtCQaEtTxjnC1zIC13xhm2ZMm5ZyQMZ555QMhhaQwf3xywye3vYT744e0OG3m+4wRsQQcSpCkfBaNgFIyCUYAdAABmW0mIcrS3hQAAAABJRU5ErkJggg==","orcid":"","institution":"University of Barcelona","correspondingAuthor":true,"prefix":"","firstName":"Marta","middleName":"","lastName":"Romero-García","suffix":""},{"id":276756212,"identity":"b18db230-0b4e-4834-96d3-f6eedbf806df","order_by":2,"name":"Isabel Anglès-Sabaté","email":"","orcid":"","institution":"Parc Tauli Hospital","correspondingAuthor":false,"prefix":"","firstName":"Isabel","middleName":"","lastName":"Anglès-Sabaté","suffix":""},{"id":276756213,"identity":"ebb9e30f-1409-45fa-9589-da7bc11a7fbe","order_by":3,"name":"Albert Ausió-Dot","email":"","orcid":"","institution":"Vic Hospital","correspondingAuthor":false,"prefix":"","firstName":"Albert","middleName":"","lastName":"Ausió-Dot","suffix":""},{"id":276756214,"identity":"0577762d-3c81-4c2f-bf91-ce8927486c1d","order_by":4,"name":"Sergio Alonso-Fernández","email":"","orcid":"","institution":"University of Barcelona","correspondingAuthor":false,"prefix":"","firstName":"Sergio","middleName":"","lastName":"Alonso-Fernández","suffix":""},{"id":276756215,"identity":"d95ef9f3-3fb1-420b-a165-f222a2496d54","order_by":5,"name":"Isidro Alcalá-Jiménez","email":"","orcid":"","institution":"Vall d'Hebron Hospital","correspondingAuthor":false,"prefix":"","firstName":"Isidro","middleName":"","lastName":"Alcalá-Jiménez","suffix":""},{"id":276756216,"identity":"f109f86f-ba5e-4980-abf1-6df8896e39ae","order_by":6,"name":"Ariadna Huertas-Zurriaga","email":"","orcid":"","institution":"Germans Trias i Pujol Hospital","correspondingAuthor":false,"prefix":"","firstName":"Ariadna","middleName":"","lastName":"Huertas-Zurriaga","suffix":""},{"id":276756217,"identity":"a1b5d166-b673-463b-9c85-f9094b12d8eb","order_by":7,"name":"Carlos Tur-Rubio","email":"","orcid":"","institution":"Can Misses Hospital","correspondingAuthor":false,"prefix":"","firstName":"Carlos","middleName":"","lastName":"Tur-Rubio","suffix":""},{"id":276756218,"identity":"9e6125cf-db79-444a-bf0f-009ba0b4156a","order_by":8,"name":"Pilar Delgado-Hito","email":"","orcid":"","institution":"University of Barcelona","correspondingAuthor":false,"prefix":"","firstName":"Pilar","middleName":"","lastName":"Delgado-Hito","suffix":""}],"badges":[],"createdAt":"2024-02-29 08:22:04","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3999021/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3999021/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12912-026-04300-z","type":"published","date":"2026-01-19T15:56:50+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":101152808,"identity":"83f7c86a-4079-466b-8b93-741c014d36a0","added_by":"auto","created_at":"2026-01-26 16:13:11","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":663315,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3999021/v1/3a1dfed2-832f-4c93-aef7-88c6e3cd343e.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"\u003cp\u003eEfficacy of the Intensive Care Unit Diary: A Mixed-Method Study Protocol\u003c/p\u003e","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003eBeing admitted to an intensive care unit (ICU) can be a stressful event for both patients and their families, leading to a high prevalence of disorders during and after hospitalisation.\u003csup\u003e1,2\u003c/sup\u003e Although ICU survival has increased by 18 to 46%,\u003csup\u003e3\u003c/sup\u003e patients who are discharged may present physical, respiratory, motor and/or muscular disorders; cognitive disorders, such as memory impairments and lack of concentration/attention; emotional disorders related to fear; and also psychiatric symptoms, such as depression, anxiety, stress, and/or post-traumatic stress syndrome (PTSD), reducing their quality of life.\u003csup\u003e1–3\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eOne challenge that can occur after a stay in the UCI is post-intensive care syndrome (PICS). The Society of Critical Care Medicine defines PICS as the set of signs and symptoms that encompass the cognitive, psychological, and physical problems that people face after a prolonged ICU admission.\u003csup\u003e4\u003c/sup\u003e PICS not only affects the critically ill patient but also family members, both psychologically and socially, with symptoms such as PTSD, depression, complicated grief, and anxiety. When the person affected is a family member, the condition is called post-intensive care syndrome in families (PICS-F).\u003csup\u003e5\u003c/sup\u003e PICS and PICS-F have their onset when the patient is admitted to the ICU and continue after discharge—sometimes for years. This is why care of critical patients should be improved to incorporate, on the one hand, rehabilitation and, on the other, the follow-up of patients once they have been discharged from the ICU, both in the same hospital and at home. Doing so makes it possible to prevent or minimise the sequelae of their admission.\u003csup\u003e1,5\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eAmong the measures to prevent PICS and PICS-F is the use of the ICU diary.\u003csup\u003e2,6–11\u003c/sup\u003e The ICU diary first emerged in the 70s from the initiative of nurses in Scandinavia. It became common practice in some European countries, although the diaries are little used in other countries around the world, especially Spanish-speaking ones.\u003csup\u003e11–13\u003c/sup\u003e The diary is a coherent and personal narrative of support and encouragement to patients that explains in colloquial language their health process, daily life, and behaviour during their stay in the ICU, respecting their privacy and integrity.\u003csup\u003e14\u003c/sup\u003e The diary is written in an empathetic and reflective style and employs therapeutic communication with a double objective, that of caring and healing.\u003csup\u003e15\u003c/sup\u003e The diaries are written by the patient’s family or friends and by the health care professionals involved in their care, with nurses leading the production of the diary.\u003c/p\u003e \u003cp\u003eIt is advisable to write the diary on loose leaf paper (a maximum of 20). In addition to narrative text, diaries can include photos, drawings, and/or poems.\u003csup\u003e15\u003c/sup\u003e A nurse writes the first entry of the diary, greeting the patient and explaining the reasons for their admission to the ICU. From this first entry and throughout the patient’s stay, successive entries are written by relatives, friends, and healthcare personnel to describe the patient’s evolution. Finally, upon discharge from the ICU, the nurse makes a final entry to conclude the narrative and say goodbye to the patient.\u003c/p\u003e \u003cp\u003eThe ICU diary has a chronological structure and involves an investment of time, with a directly proportional relationship between the expertise of the nurses and the nurse/patient ratio with the time invested in the entries.\u003csup\u003e16\u003c/sup\u003e In this sense, the diary is a tool for a comprehensive vision of patient- and family-centred care and is a nursing intervention that is easy to use, low-tech, and low-cost. Despite these advantages, there can be difficulties in starting and completing the diaries due to a lack of human resources and training and the excess workload that ICU nurses experience,\u003csup\u003e6,7,12,13,15\u003c/sup\u003e The use of diaries shows acceptance by patients, family members, and professionals, as they consider the diary to be a beneficial tool in the healing process that influences the psychological well-being of patients, family members, and professionals.\u003csup\u003e16–18\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eExisting research suggests that the ICU diary provides several benefits to critically ill patients. It allows them to know what happened during their stay, distinguish fact from fiction, promote memory and improve amnesia, helping them to build their own narrative of the health situation they have experienced.\u003csup\u003e6,12,14,19–26\u003c/sup\u003e In addition, the ICU diary can be a catalyst for dialogue to help the patient make sense of what happened and thus improve their understanding of their dreams and their perceptions of the care received.\u003csup\u003e6,27\u003c/sup\u003e Some authors claim that the use of diaries can reduce anxiety, scores on the Acute Physiology and Chronic Health Evaluation (APACHE II) Disease Severity Scale, and depression, promoting a higher health-related quality of life (HRQoL) after admission to the ICU.\u003csup\u003e10\u003c/sup\u003e However, other studies do not find significant differences in terms of anxiety or post-traumatic stress in patients who have used the diary, but find that the use of diaries is associated with a lower risk of depression and a better quality of life. \u003csup\u003e26\u003c/sup\u003e Some authors note that the sample size in their studies or the methods used could be the reason for the inconclusive results obtained, and therefore they recommend multicentre experimental studies with large sample sizes in order to verify their findings.\u003csup\u003e26\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eIn terms of the benefits for families, several authors point out that the ICU diary allows family members to narrate events, express their feelings, and communicate with the person admitted to the ICU, making them feel useful.\u003csup\u003e7,8,25,28\u003c/sup\u003e It is a mechanism for exchanging information to access, understand, accept, and assimilate the information received about their family member’s health situation and thus share it with the rest of the family. This can help the family member become aware of the importance of their role as a caregiver, especially to later help them build their own narrative of the health situation experienced during the patient’s stay in the ICU.\u003csup\u003e6,18,19\u003c/sup\u003e In this sense, diaries have been identified as sources of comfort and security, supporting the bond with the critically ill patient as a person, improving communication, humanisation, and understanding of the patient’s therapeutic plan or evolution, which produces benefits for both patients and family members and humanises ICUs.\u003csup\u003e17,19,29–31\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eResearch has also suggested that the diary can improve the well-being of the family, producing positive effects and serving as a vector that connects the patient, the family, and health professionals, helping them on the one hand, to channel the anxiety caused by having a loved one admitted to an ICU and, on the other hand, to recover psychologically after a critical health situation, reducing symptoms related to post-traumatic stress.\u003csup\u003e9\u003c/sup\u003e But there is also a meta-analysis that concludes that ICU diaries do not seem to have any beneficial effect on the family members of ICU patients,\u003csup\u003e26\u003c/sup\u003e and other studies affirm that some family members do not want to expose themselves by expressing their feelings in the diary for fear of being read. For these family members, the ICU diary can become a great challenge and source of anguish.\u003csup\u003e14\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eFinally, the reported benefits of the ICU diary for professionals include personal satisfaction, the feeling of performing a job differently and well, and the personal connection with the patient and the family.\u003csup\u003e25,29,32\u003c/sup\u003e In addition, the increase in the visibility of nursing care is evident, as it provides new knowledge about nursing actions.\u003csup\u003e14, 29,33,34\u003c/sup\u003e On the other hand, the literature shows that professionals associate their workload, their lack of knowledge or creativity, and the work environment as potentially distressing obstacles in the process of writing ICU diaries.\u003csup\u003e25\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eThe literature delineates the existence of journal implementation without a systematic plan to assess its effects (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e). Considerable variability exists regarding the design of the diary, language barriers, decisions about who writes in the diary, and the inclusion or exclusion of photographs in the narrative, considering the ethical and legal aspects of their utilisation (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). Also, concern arises regarding the emotional immersion of the professional and the sense of intrusion into the privacy of the patient and their family, aspects that must be taken into consideration in the execution of the journal (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eJustification\u003c/p\u003e \u003cp\u003eICU diaries are used internationally in ICUs as a tool to promote the recovery of patients and their families. While almost all existing research points to the benefits of using the ICU diary, the studies have limitations, such as small sample sizes and lack of control groups in quantitative studies and an overall paucity of mixed-methods research. Therefore, in multiple published articles, researchers recommend further examination of the benefits of the use of diaries in terms of post-traumatic stress, depression, anxiety, and the improvement of well-being and quality of life, both for people cared for in ICUs and for family members, conducting studies with adequate statistical power to provide more solid evidence..\u003csup\u003e25,26\u003c/sup\u003e Several authors recommend applying mixed methods in order to triangulate data on the subject and to be able to understand the lived experience of all participant types (patient, family member, professional) before implementing diaries routinely.\u003csup\u003e6,12,13,25\u003c/sup\u003e\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e\u003c/p\u003e\n\u003ch3\u003eOBJECTIVES\u003c/h3\u003e\n\u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo assess the impact of the use of a diary for patients admitted to an ICU and their family members in terms of health-related quality of life, post-traumatic stress, and anxiety/depression at 2, 6 and 12 months after discharge from the ICU.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo understand the experience of patients and their family members in using the diary and to assess the satisfaction of the nurses who lead the practice of the ICU diary.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e"},{"header":"METHODS","content":"\u003cp\u003e\u003cstrong\u003eDesign\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis parallel, open-label, non-blinded, multicentre, mixed-method study will be conducted in two phases, a quantitative phase followed by a qualitative phase. To achieve the first objective, a quantitative design will be used through a randomised clinical trial with an experimental group and a control group.\u0026nbsp;To achieve the second objective, a hermeneutical phenomenological study according to Heidegger (1990) will be carried out in a constructivist paradigm (Guba and Lincoln).\u003csup\u003e35,36\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePHASE 1\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eScope of study\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe scope of study is the adult ICUs of national hospitals in Spain. Each participating ICU has a principal investigator who coordinates the project at their hospital. The selection of participating hospitals is made through an appeal to Spanish ICUs from the Spanish Society of Intensive Care Nursing and Intensive Care Units. The society’s endorsement is requested, and the interested ICUs are then contacted.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Population and Sample\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study population is all patients admitted to the participating ICUs and their family representatives from January 2023 to December 2024. The sample size was calculated considering the average number of patients admitted to Spanish ICUs and the results of previous studies. We determined the sample size using the Argimon table\u003csup\u003e37\u003c/sup\u003e to compare two proportions, accepting a risk α of 0.05 and a risk β of 0.2 in a bilateral contrast in independent variables, 120 subjects in the experimental group and 120 in the control group are needed to detect a difference between two proportions as statistically significant. This is expected to be 0.30 for the experimental group and 0.15 for the control group.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor each of the hospitals, the necessary sample size is determined based on the annual admissions of each participating ICU.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003ePatients\u003c/u\u003e who meet the following criteria are included in the study:\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion criteria:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e-Minimum ICU stay of 72 hours\u003c/p\u003e\n\u003cp\u003e-Sedated with orotracheal intubation and connected to invasive mechanical ventilation for a minimum of 24 hours\u003c/p\u003e\n\u003cp\u003e- Willingness of the family. Signed informed consent to participate in the study\u003c/p\u003e\n\u003cp\u003e-Patients and family members who can speak, read, and write in Catalan or Spanish\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion criteria:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e-History of psychiatric or mental problems\u003c/p\u003e\n\u003cp\u003e-Cognitive alterations recorded in the patient’s medical history\u003c/p\u003e\n\u003cp\u003e-Have suffered serious trauma in the last year\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWithdrawal criteria\u0026nbsp;\u003c/strong\u003eduring the study:\u003c/p\u003e\n\u003cp\u003e-Death of the patient during the ICU stay or the duration of the study\u003c/p\u003e\n\u003cp\u003e- Revocation of informed consent by the family member or the patient\u003c/p\u003e\n\u003cp\u003e-Discharge from the ICU to another hospital\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e-Failure to attend scheduled visits 2, 6 and 12 months after discharge\u003c/p\u003e\n\u003cp\u003eAs for \u003cu\u003efamily members\u003c/u\u003e, a reference family member for each critical patient who has a close and personal relationship with the patient will be selected to participate in the study.\u003c/p\u003e\n\u003cp\u003eA non-probabilistic random sampling will be carried out by consecutive recruitment until the sample size is complete. \u0026nbsp;A randomisation table will be used to assign patients to the experimental group or the control group.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eControl group: application of the usual practice of the ICU, with daily information about the events in the ICU and the patient’s evolution and condition, provided orally. Experimental group: The usual practice, plus an ICU diary will be kept by family members and health personnel.\u003c/p\u003e\n\u003cp\u003eThe \u003cu\u003ediary\u003c/u\u003e consists of a ringed binder, A4 size, white, washable, and reusable. The elements comprising the diary are the front cover, back cover, glossary, and blank sheets for writing. Each patient's diary is provided by the principal investigator (PI) of the study to each participating centre. This diary includes information about the patient’s physical condition, procedures and treatments, and significant events that occurred inside and outside the unit. Photographs of the patient are not included.\u003c/p\u003e\n\u003cp\u003eHealth care professionals receive the “guidelines for writing the diary (for professionals)” and the family members receive the “guidelines for writing the diary (for family members)”, written by the research team. Before starting the study, the PI at each centre conducts a training session for ICU professionals on the use of diaries. The audiovisual material necessary to carry out this training is provided by the PI of the study.\u003c/p\u003e\n\u003cp\u003eBoth the experimental group and the control group undergo three follow-up visits as part of the study, scheduled for 2, 6 and 12 months after discharge. At these visits, the questionnaires are administered to both the patient and the family member. The first visit takes place in person, and subsequent visits are carried out online.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy variables\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe independent variable is \u003cem\u003e\u003cu\u003euse of the ICU diary\u003c/u\u003e\u003c/em\u003e. A nurse and/or the family member writes a diary entry at the time of ICU admission. This variable is dichotomous (yes / no).\u003c/p\u003e\n\u003cp\u003eThe dependent variables are:\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eHealth-related quality of life (HRQoL).\u003c/u\u003e\u003c/em\u003e The WHO (1994) defined quality of life as an individual’s perception of their position in life in the context of the culture and value system in which they live and in relation to their goals, expectations, standards, and concerns. The WHOQOL\u003csup\u003e38\u003c/sup\u003e Group established a series of points accepted by various groups of researchers in relation to HRQoL measures, among which they highlight that they must be subjective, multidimensional, include positive and negative feelings, and record variability over time.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003ePost-traumatic stress.\u003c/u\u003e\u003c/em\u003e Post-traumatic stress disorder (PTSD) is a debilitating condition that can occur after experiencing a traumatic event and is defined as feelings of horror and hopelessness linked to something we see, hear, or experience.\u003csup\u003e39,40\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eAnxiety/depression.\u003c/u\u003e\u003c/em\u003e Depression is a mood disorder—transitory or permanent—characterised by feelings of dejection, unhappiness, and guilt, as well as causing a total or partial inability to enjoy everyday life. Depressive disorders can be accompanied by anxiety.\u003csup\u003e41\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSecondary variables:\u003c/p\u003e\n\u003cp\u003eFirst of all, we will collect the variables related to the patient’s sociodemographic data: Date and time of admission and discharge, age (reflected in age in years at the time the study begins), sex (male, female), main relationship between patient and family representative (partner, father-mother, child, grandfather-grandmother, friend, grandchild, sibling, brother-in-law, daughter-in-law, uncle, nephew, other), educational level (no studies, compulsory primary education, compulsory secondary education, baccalaureate, unified polyvalent baccalaureate [secondary school in the previous education system], university orientation course [post-secondary university-preparatory course, in the previous education system], professional modules, vocational training, bachelor’s degree, \u0026nbsp;master's degree, doctorate) and finally, whether or not they have had an experience with an ICU previously, for both the patient and the family member.\u003c/p\u003e\n\u003cp\u003eSecond, the variables related to the patient’s clinical data:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eVariables at admission:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e-Admission (urgent, scheduled), type of admission (procedures, medical or trauma, elective surgery, urgent surgery), origin of admission (emergency department, operating room, emergency medical services, hospitalisation, another hospital), reason for admission (respiratory, traumatological, cardiac, neurological, infectious, renal, hepatic, coronary, immunological, urinary, digestive, other).\u003c/p\u003e\n\u003cp\u003e-APACHE II (Acute Physiology and Chronic Health Evaluation) Disease Severity Scale. This is a system of classification of disease severity. It is applied in the first 24 hours of the patient’s admission to the ICU. Values range from 0 (not severe) to 67 (maximum severity and highest risk of death).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eVariables at discharge:\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e-Number of hours with invasive mechanical ventilation expressed in hours and minutes (orotracheal intubation, tracheostomy, without mechanical ventilation).\u003c/p\u003e\n\u003cp\u003e-Onset of impaired consciousness expressed in day, month, year, hours, and minutes. We understand sedation to be when the patient is administered the first dose of sedation, either via bolus or infusion, and their level of consciousness decreases. We will specify the type of sedation used (active ingredient) and the hours of sedation (hh.mm).\u003c/p\u003e\n\u003cp\u003e-Return of normal consciousness, expressed in day, month and year, hours, and minutes and understood as the moment in which the patient presents a RASS (Richmond Agitation-Sedation Scales) of -1 and a GLASGOW (Glasgow Coma Scale) of 11 maintained for 24 consecutive hours. The RASS is a scale used to assess the degree of sedation and agitation of a patient in ICUs. The score ranges from -5 to +4, with -5 being very deep sedation and +4 being a combative state. A RASS of -1 is a drowsy state where the patient is not fully alert but stays awake (opens eyes/gazes in the direction of a voice ≥10 seconds). The GLASGOW scale is a scale to assess the level of alertness. The scale is composed of the exploration and quantification of three parameters: eye opening, verbal response, and motor response. The total score is the result of the sum of the three parameters. It ranges from 3 to 15, with 3 being the lowest value and 15 being the highest.\u003c/p\u003e\n\u003cp\u003eFinally, the variables related to the professionals: sociodemographic (age, sex, years of experience, type of contract, and position), participation in the preparation of the diary (yes/no), reasons for non-completion, difficulties encountered, benefits (for patient, family member, and professional), and degree of satisfaction (using a Likert scale of 4 response options ranging from dissatisfied to highly satisfied).\u003c/p\u003e\n\u003cp\u003eThese variables will be collected by the research team during the patient’s stay in the ICU. A specific data collection sheet has been designed for the collection of variables on admission and another for the collection of variables at discharge. Subsequently, these variables will be entered into the database provided by the study PI.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInstruments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eH\u003c/strong\u003e\u003cstrong\u003eealth-related quality of life (HRQoL)\u003c/strong\u003e will be evaluated using the SF-36 Health Questionnaire (Spanish adaptation),\u003csup\u003e39\u003c/sup\u003e which provides a profile of health status. It is a self-administered questionnaire that is completed in 5-10 minutes and consists of 36 items. The final questionnaire covers eight subscales, which represent the health concepts most frequently used in the main health questionnaires: physical functioning, social functioning, role (physical), role (emotional), mental health, vitality, bodily pain, and general health. It specifies two components: physical component score (PCS, range: 0-100) and mental component score (MCS, range: 0-100). The score ranges from 0 to 100, with a mean of 50 and a standard deviation of 10. Regarding the questionnaire’s psychometric properties, the scales show good internal consistency, starting with Chronbach’s alpha, which obtains values above 0.70 in all scales except for social function (0.69). It presents good temporal stability based on the intraclass correlation index, with values ranging from 0.58 on the emotional role scale to 0.99 on the physical role scale.\u003csup\u003e42\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePTSD\u003c/strong\u003e will be assessed using the EIE-R\u003csup\u003e40\u003c/sup\u003e (“Escala revisada del impacto del estresor” in Spanish), the Spanish version adapted from the original Impact of Events Scale Revised. The original version of the instrument was designed by Horowitz in 1979 and revised by Weiss and Marmar in 1997.\u003csup\u003e43\u003c/sup\u003e It is a self-administered scale that assesses the subjective distress that accompanies and follows stressful and/or traumatic experiences. It is made up of two subscales and fifteen items, seven that assess responses related to intrusion and eight related to avoidance. Subsequently, Weiss and Marmar’s group developed seven additional items, six aimed at the hyperarousal subscale and one more for the intrusion subscale. Each of the 22 items is weighted on a Likert-type scale intervals, with values of 0 (not at all), 1 (rarely), 3 (sometimes) and 5 (often). (Range: 0-88). Reliability studies provided good internal consistency determined by a Chronbach’s alpha index of 0.86 for the total scale, 0.78 for the intrusion subscale, and 0.82 for the avoidance subscale.\u003csup\u003e43\u003c/sup\u003e The two subscales have a significant correlation (\u003cem\u003er\u003c/em\u003e=0.42). In test-retest studies at one-week intervals, the coefficients were 0.87 for the total scale, 0.89 for the intrusion subscale, and 0.79 for the avoidance scale. In terms of convergent validity, the scale is associated with other measures of chronic stress including somatic complaints, problems with concentration and interpersonal relationships, depression, anxiety, anger, fear, alienation, and other physiological states.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAn\u003c/strong\u003e\u003cstrong\u003exiety/depression\u003c/strong\u003e will be assessed using the Hospital Anxiety and Depression Scale (HADS), designed by Zigmond and Snaith\u003csup\u003e41\u003c/sup\u003e in 1982 in English and adapted/validated in Spanish.\u003csup\u003e44,45\u003c/sup\u003e The scale, designed to identify the possibility or probability of anxiety disorders and depression in patients admitted to non-psychiatric clinics, is made up of two factors, anxiety (HADS-A) and depression (HADS-D). Each of the factors has seven items that correspond to a particular mood, followed by four possible indicators of how often the respondent has experienced this feeling in the previous week. Each item generates 0 to 3 points. Odd-numbered items refer to anxiety, and even-numbered items refer to depression. The calculation of the final value is carried out independently for each factor, obtaining two measurement parameters (range: 0-21). Scores of 8-10 suggest the likely presence of signs of depression/anxiety and scores above 15 imply severe affective disorders. Factor structure has been examined in 19 studies, showing a structure of two, three or four factors. The two-factor structure was stable in the different age and gender groups. A positive correlation was observed between the two factors (Pearson 0.49-0.74). The internal consistency of the scale, determined by the Chronbach’s alpha index, varies in the HADS-A subscale from 0.68 to 0.93 (mean 0.83) and in HADS-D from 0.67 to 0.390 (mean 0.82)\u003csup\u003e45\u003c/sup\u003e with a cut-off point of 8 for the two subscales. The sensitivity and specificity of both is close to 0.80. It shows concurrent validity with the Becks Depression Inventory BDI (0.62-0.73 for HADS-D, 0.61-0.83 for HADS-A and 0.73 for the total scale). It has also been evaluated with the General Health Questionnaire (GHQ-28), and Clinical Anxiety Scale, Spielberg's State-Trait Inventory (STAI), with adequate correlations.\u003c/p\u003e\n\u003cp\u003eThese questionnaires will be administered to the patient and family representative at each of the post-discharge visits (at 2, 6, and 12 months). The approximate time taken to complete the questionnaires is 10 min. The answers to the questionnaires will be transferred by the PI at each centre to the database that will be provided, and the study PI study will interpret the results.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData collection procedure\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFrom the start date of the study, all patients admitted to the ICU who meet the inclusion/exclusion criteria of the study will be invited to participate. The family representative will be contacted and, after an explanation of the study, will be offered the opportunity to participate. If they agree to participate, the study information sheet will be provided and informed consent will be requested.\u003c/p\u003e\n\u003cp\u003eThe completion of the study entry registration sheet will begin, and the patient will be assigned to the experimental or control group, according to a previously designed randomisation table, until the sample size is reached. The family representative will be informed of the assigned group and those who are assigned to the experimental group will be given the guidelines on writing an ICU diary for a relative. Likewise, the nurse responsible for the patient at that time will be informed of the group assignment, so that they can start the diary or not and leave a note in the patient’s nursing record.\u003c/p\u003e\n\u003cp\u003eThe diary will be placed by the PI in the patient’s box, at the foot of the bed, accessible to anyone who wants to participate in writing in it during their stay in the ICU. The variable collection sheet will begin to be completed upon the patient's admission.\u003c/p\u003e\n\u003cp\u003eAt the time of discharge, the diary will be removed and safeguarded to ensure confidentiality. Correct compliance with the study entry record sheet and the variable collection sheet at the patient's admission will be ensured, and a second variable collection sheet will be initiated at the patient’s discharge. Finally, after discharge, the PI will contact the patient to explain the study again, and, if they agree, proceed to sign a confirmation of consent.\u003c/p\u003e\n\u003cp\u003eThe first follow-up visit, after 2 months, will be face-to-face, and the patient will be accompanied by the family representative. Both will fill out the questionnaires that assess HRQoL, stress, and anxiety/depression. The completion of the variable collection sheet for the follow-up visits will begin.After the scales have been administered, participants in the experimental group will read their ICU diary. At this point, patients will take their diary home with them. Both groups will be rescheduled at 6 months and 12 months, for a virtual visit where the three instruments will be administered again, and the experimental group will be offered the opportunity to comment on the content of the diary if they choose. Once the multicentre study is completed, the study PI will report the final data from each centre to its PI.\u0026nbsp;Finally, a voluntary survey will be carried out with ICU professionals (who give their informed consent) about their opinion and degree of satisfaction with the use of the ICU diary.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePilot test\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA pilot test will be carried out in the sponsoring hospital with 20 patients, to test the proposed data collection procedure and to assess any difficulties of fieldwork. Subjects included in this test will not be used in the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData analysis: type of analysis and software\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data will be processed using the IBM SPSS v.24 program, and a descriptive and inferential analysis will be performed. For the description of the sample, centralisation, and dispersion parameters (mean, median, standard deviation, and dispersion) will be used for the quantitative variables, and the results will be reported in the form of percentages and frequencies for the qualitative variables. A descriptive analysis will be carried out to determine the satisfaction of the professionals.\u003c/p\u003e\n\u003cp\u003ePrior to the bivariate analysis, the normality of the sample distribution will be evaluated. Student’s t-test, chi-square statistic, and ANOVA will be applied according to the study variables, as well as other non-parametric tests depending on the normality of the sample. Finally, as this is a longitudinal study, an analysis of the variance of repeated measures will be performed. The level of significance for hypothesis testing will be p£0.05.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePHASE 2 OF THE STUDY\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eParticipants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study population will be all patients and family representatives who have participated in the experimental group in the study period, according to the characteristics of the sample, of the hospital conducting the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe characteristics of the sample will be as follows:\u003c/p\u003e\n\u003cp\u003e-Has participated in the first part of the study within the experimental group\u003c/p\u003e\n\u003cp\u003e-Is able to testify to their experience: ability to express their experience orally, without limitations in oral communication\u003c/p\u003e\n\u003cp\u003e-Has attend and participated in follow-up visits\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e-Has signed informed consent form\u003c/p\u003e\n\u003cp\u003eThe sampling will be theoretical and non-probabilistic, of maximum variation, until reaching data saturation. Eighteen patient profiles will be created by crossing the following sociodemographic parameters: age (18-40, 41-70, 71-100), sex (male/female), and education level (no formal education, primary or secondary studies, university studies). For each profile, we will include three to four patients, until reaching theoretical saturation, resulting in a final sample of between 36 and 72 patients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCollection and intervention techniques and procedure\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe technique used will be an in-depth interview with the patient and the family representative of the experimental group 6 months after discharge (at the second follow-up visit) with the support of the field diary. The interview will be conducted based on a script in a ward of the same hospital. An observer will be present. \u0026nbsp; The estimated duration will be one hour, and the sessions will be audio-recorded and transcribed. Transcripts will be sent by email to the participants for validation. The field diary will allow researchers to collect methodological notes, theoretical notes, descriptive notes, and personal notes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQuality and rigour criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe criteria of quality and rigour determined by Lincoln and Guba (1985) and the emerging criteria of Lincoln (1996) will be followed.\u003csup\u003e35\u003c/sup\u003eThe strategies that will be carried out to preserve rigour are confirmation by participants, recognition of biases, triangulation of researchers for data analysis and triangulation of data (patients, family representatives, and professionals), use of theoretical sampling of participants to ensure their representativeness, detailed description of subjects, contexts and situations (transferability). Moreover, several research team members are experts in qualitative methods. The roles of the researcher and the participants are well throughout the study. Finally, a field diary will be used, in addition to the collection of data with the highest level of detail and including direct quotes. The recording of the interviews and subsequent confirmation with the patient or family member will also help to ensure that quality of the data and the interpretations and proposals that we make based on them.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAnalysis of information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe type of phenomenological analysis proposed by Smith will be used.\u003csup\u003e46\u003c/sup\u003e The data for each participant will be analysed, respecting the nature of the participant, before moving on to the next case. The analysis will be carried out in seven stages: (1) reading and re-reading: first by listening to the recordings and reading transcripts to get a sense of the whole, (2) initial annotations, (3) development of emerging themes, (4) search for connections between emerging themes, (5) moving on to the next case, (6) search for patterns between cases, (7) writing. To facilitate the management of the data obtained, the qualitative analysis software QSR NVivo 12.0 will be used. \u0026nbsp;\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eKeeping an ICU diary is a challenge for nurses and family members, as it is a novel intervention in many countries. This study considers the limitations and future lines recommended in previous studies. By proposing a mixed, multicentre experimental study that contemplates all the agents involved in the process (patients, family, and professionals) and considers the satisfaction of professionals, the results will provide rigorous and robust data regarding the use of ICU diaries. This study will determine the efficacy of the ICU diary in terms of HRQoL, post-traumatic stress, and anxiety/depression, for both patients and their families based on quantitative and qualitative data. Evaluating the results of their use and understanding the lived experience of using the diary will provide knowledge about their efficacy, since the results of this study will demonstrate the benefits and limitations of their use. The results of this study will give us much more definitive answers about the efficacy of the ICU diary. If the benefits suggested by prior research are confirmed, units that are already using the diaries can fine-tune their practice in response to information about specific effects. For units that have yet to fully implement the ICU diary, this outcome could encourage a fuller roll-out of the diary.\u003c/p\u003e"},{"header":"LIMITATIONS","content":"\u003cp\u003eThis study has several potential limitations. The first is the lack of blinding of the patients, family members, nurses, and researchers. This weakness will be considered when interpreting the final results of the study. The second limitation is the fact that the scale used to assess HRQoL does not include some important health factors, such as sleep disorders, cognitive function, family function, and sexual function. Thirdly, the fact that the participating hospitals do not have experience in the preparation of the diary may make the study difficult. For this reason and to minimise the variability in the records, a training session will be carried out beforehand with the participating professionals and they will be provided with guidelines about how to keep an ICU diary. These limitations are counteracted by important strengths: This is the first mixed-methods study that evaluates the efficacy of the use of the ICU diary and the satisfaction of professionals, considering quantitative and qualitative aspects, in a multicentre, experimental study.\u003c/p\u003e \u003cp\u003eUnderstanding patients\u0026rsquo; experiences can help nurses standardise the implementation of the ICU diary, allowing comparability and, of course, providing us with valuable information regarding the perceptions, beliefs, and values associated with this nursing intervention. In this way, we can better understand how best to implement ICU diaries for maximum efficacy.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eAPACHE: Acute Physiology and Chronic Health Evaluation\u003c/p\u003e\n\u003cp\u003eHRQoL: Health-related quality of life\u003c/p\u003e\n\u003cp\u003eEIE-R: Impact of Events Scale Revised\u003c/p\u003e\n\u003cp\u003eHADS: Hospital Anxiety and Depression Scale\u003c/p\u003e\n\u003cp\u003ePI: principal investigator\u003c/p\u003e\n\u003cp\u003eMCS: mental component score\u003c/p\u003e\n\u003cp\u003eWHO: World Health Organisation\u003c/p\u003e\n\u003cp\u003ePCS: physical component score\u003c/p\u003e\n\u003cp\u003ePICS: post-intensive care syndrome\u003c/p\u003e\n\u003cp\u003ePICS-F: post-intensive care syndrome in families\u003c/p\u003e\n\u003cp\u003eSF-36\u003cem\u003e:\u0026nbsp;\u003c/em\u003eShort Form-36 Health Survey\u003c/p\u003e\n\u003cp\u003ePTSD: post-traumatic stress disorder\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eICU: intensive care unit\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eETHICS APPROVAL AND CONSENT TO PARTICIPATE\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study has the approval of all the ethics and research committees of the participating hospitals. The ethical principles of respect, beneficence, determination, and justice will be considered. The research will be carried out in accordance with the Declaration of Helsinki and the Belmont report, the Law on Patient Autonomy: Obtaining Informed Consent (Law 41/2002), Organic Law 3/2018, of 5 December, on Personal Data Protection, and the provisions of European Regulation No. 2016/679 on General Data Protection. This study has been approved by the participating hospitals. To maintain the confidentiality of participants, alphanumeric codes will be used. Only the IP will have access to the database, which will be password protected.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSENT FOR PUBLICATION\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAVAILABILITY OF DATA AND MATERIALS\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCOMPETING INTERESTS\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors of the study declare that they have no competing interests\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFUNDING\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study has been funded by the Nurse and Society Foundation (PR-284/18) and the Talents Scholarship, Catalonia Foundation la Pedrera, Talents 2018.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAUTHORS’ CONTRIBUTIONS\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePMR, MRG and PDH made substantial contributions to conceptualization and design.\u003c/p\u003e\n\u003cp\u003ePMR, SAF and AHZ were involved in the acquisition of the financial support.\u003c/p\u003e\n\u003cp\u003ePMR, MRG and PDH oversight and leadership responsibility for the research planning and execution.\u003c/p\u003e\n\u003cp\u003eAll authors were involved in drafting the manuscript or revising it critically for important intellectual content.\u003c/p\u003e\n\u003cp\u003eAll authors gave final approval of the version published.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll authors agreed to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eACKNOWLEDGEMENTS\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank all the patients and nurses who will participate in this study, as well as all the participating hospitals.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eAndresen M, Guic E, Orellana A, Diaz MJ, Castro R. 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Intensive care diaries and relatives\u0026apos; symptoms of posttraumatic stress disorder after critical illness: a pilot study. Am J Crit Care. 2012 May; 21(3):172-6. \u003c/li\u003e\n\u003cli\u003eKnowles RE, Tarrier N. Evaluation of the effect of prospective patient diaries on emotional well-being in intensive care unit survivors: a randomized controlled trial. Crit Care Med. 2009 Jan; 37(1):184-91. \u003c/li\u003e\n\u003cli\u003eBrandaoB, Luz M, Gusmao-Flores D. Using Qualitative Synthesis to Explore Heterogeneity of Randomized Trials on ICU Diaries. Crit Care Med. 2022 Nov 1; 50(11):1654-61. \u003c/li\u003e\n\u003cli\u003eAitken LM, Rattray J, Hull A, Kenardy JA, Le Brocque R, Ullman AJ. The use of diaries in psychological recovery from intensive care. Crit Care. 2013 Dec 18; 17(6):253. \u003c/li\u003e\n\u003cli\u003eMu\u0026ntilde;oz MP, Villanueva C, Alonso S, Cuzco C, Romero-Garc\u0026iacute;a M, Delgado-Hito MP. 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Intensive Care Med. 2021 Jul;47(7):737-49. \u003c/li\u003e\n\u003cli\u003eBarreto BB, Luz M, Rios MNO, Lopes AA, Gusmao-Flores D. The impact of intensive care unit diaries on patients\u0026apos; and relatives\u0026apos; outcomes: a systematic review and meta-analysis. Crit Care. 2019 Dec 16;23(1):411. \u003c/li\u003e\n\u003cli\u003eAitken LM, Rattray J, Kenardy J, Hull AM, Ullman AJ, Le Brocque R, et al. Perspectives of patients and family members regarding psychological support using intensive care diaries: An exploratory mixed methods study. J Crit Care. 2017 Apr; 38: 263-8. \u003c/li\u003e\n\u003cli\u003eGlimelius Petersson C, Ringdal M, Apelqvist G, Bergbom I. Diaries and memories following an ICU stay: a 2-month follow-up study. Nurs Crit Care. 2015 May 25. \u003c/li\u003e\n\u003cli\u003eJohansson M, Wahlin I, Magnusson L, Hanson E. Nursing staff\u0026rsquo;s experiences of intensive care unit diaries: a qualitative study. Nurs Crit Care. 2019; 24: 407-13, 10.1111/nicc.12416\u003c/li\u003e\n\u003cli\u003eSchofield R, Dibb B, Coles-Gale R, Jones CJ. The experience of relatives using intensive care diaries: A systematic review and qualitative synthesis. Int J Nurs Stud. 2021 Jul; 119:103927. \u003c/li\u003e\n\u003cli\u003eGarrouste-Orgeas M, P\u0026eacute;rier A, Mouricou P, Gr\u0026eacute;goire C, Bruel C, Brochon S, Philippart F, Max A, Misset B. Writing in and reading ICU diaries: qualitative study of families\u0026apos; experience in the ICU. PLoS One. 2014 Oct 16;9(10):e110146. \u003c/li\u003e\n\u003cli\u003eHester M, Ingalls NK, Hatzfeld JJ. Perceptions of ICU Diary Utility and Feasibility in a Combat ICU. Mil Med. 2016 Aug; 181(8):895-9.\u003c/li\u003e\n\u003cli\u003eGalvin IM, Leitch J, Gill R, Poser K, McKeown S. Humanization of critical care-psychological effects on healthcare professionals and relatives: a systematic review. Can J Anaesth. 2018 Dec; 65(12):1348-1371. \u003c/li\u003e\n\u003cli\u003eH\u0026ouml;gvall LM, Egerod I, Herling SF, Rust\u0026oslash;en T, Berntzen H. Finding the right words: A focus group investigation of nurses\u0026apos; experiences of writing diaries for intensive care patients with a poor prognosis. Aust Crit Care. 2023 Mar 16: S1036-7314(23)00029-2. \u003c/li\u003e\n\u003cli\u003eGuba E, Lincoln Y. Paradigmas en competencia en la investigaci\u0026oacute;n cuialitativa. In: Compilaci\u0026oacute;n de Denman C. y Haro J.A., editor. Por los rincones Antolog\u0026iacute;a de m\u0026eacute;todos cualitativos en la investigaci\u0026oacute;n social.2002. p.113-45.\u003c/li\u003e\n\u003cli\u003eRam\u0026iacute;rez M, C\u0026aacute;rdena M, Rodr\u0026iacute;guez S. El Dasein de los cuidados desde la fenomenolog\u0026iacute;a hermen\u0026eacute;utica de Mart\u0026iacute;n Heidegger. Enferm Universitaria 2015; 12 (3): 144-51.\u003c/li\u003e\n\u003cli\u003eArgimon JM, Jim\u0026eacute;nez J. M\u0026eacute;todos de investigaci\u0026oacute;n cl\u0026iacute;nica y epidemiolog\u0026iacute;ca. (3\u0026ordf; Ed.). Barcelona: Elservier;2010.\u003c/li\u003e\n\u003cli\u003eWHOQOL GROUP (1995). The World Health Organization Quality of life assessment (WHOQOL). Position Paper from the World Health Organization. Soc. Sci. Med. Vol. 41, N\u0026ordm; 10, pp. 1.403-9.\u003c/li\u003e\n\u003cli\u003eAlonso J, Prieto L, Ant\u0026oacute; JM. [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results]. Med Clin (Barc). 1995 May 27; 104(20):771-6. \u003c/li\u003e\n\u003cli\u003eB\u0026aacute;guena MJ, Villarroya E, Bele\u0026ntilde;a A, D\u0026iacute;az A, Rold\u0026aacute;n C, Reig R. Propiedades psicom\u0026eacute;tricas de la versi\u0026oacute;n espa\u0026ntilde;ola de la escala revisada de impacto del estresor (EIE-R). An\u0026aacute;lisis y modificaci\u0026oacute;n de conducta. 2001;114 (27): 581-604.\u003c/li\u003e\n\u003cli\u003eZigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70.\u003c/li\u003e\n\u003cli\u003eVilagut G, Ferrer M, Rajmil L, Rebollo P, Permanyer-Miralda G, Quintana JM. et al. El Cuestionario de Salud SF-36 espa\u0026ntilde;ol: una d\u0026eacute;cada de experiencia y nuevos desarrollos. Gac Sanit 2005 Abr; 19( 2 ): 135-50. \u003c/li\u003e\n\u003cli\u003eWeiss DS, Marmar Ch, Metzler T, Ronfeldt HM. Predicting symptomatic distress in emergency services personnel. Journal of Consulting and Clinical Psychology 1995; 63: 361-8. \u003c/li\u003e\n\u003cli\u003eTejero A, Guimera E, Farre\u0026acute; JM, Peri JM. Uso cl\u0026iacute;nico del HAD (Hospital Anxiety and Depression Scale) en poblaci\u0026oacute;n psiqui\u0026aacute;trica: un estudio de sensibilidad, fiabilidad y validez. Revista del Departamento Psiquiatr\u0026iacute;a la Facultad Med Barcelona 1986; 12:233\u0026ndash;8.\u003c/li\u003e\n\u003cli\u003eTerol MC, L\u0026oacute;pez-Roig S., Rodr\u0026iacute;guez-Mar\u0026iacute;n J, Mart\u0026iacute;n-Arag\u0026oacute;n M, Pastor MA, Reig MT. Propiedades psicom\u0026eacute;tricas de la Escala Hospitalaria de Ansiedad y Estr\u0026eacute;s (HAD) en poblaci\u0026oacute;n espa\u0026ntilde;ola. Ansiedad y Estr\u0026eacute;s 2007; 13 (2-3): 163-76.\u003c/li\u003e\n\u003cli\u003eSmith JA, Flowers P, Larkin M. Interpretative Phenomenological Analysis: Theory, Method and Research. Qualitive Research in Psychology. SAGE Publications.2009;232\u003c/li\u003e\n\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":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-nursing","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"nurs","sideBox":"Learn more about [BMC Nursing](http://bmcnurs.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/nurs/default.aspx","title":"BMC Nursing","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Mixed protocol, intensive care unit, diary, nurse, anxiety, depression, post-traumatic stress, quality of life, patients, family","lastPublishedDoi":"10.21203/rs.3.rs-3999021/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3999021/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u0026nbsp;\u003c/strong\u003eMultiple international studies report on the use of diaries in intensive care units. Some highlight the benefits for patients, others focus on family members, and few consider the vision of professionals. Most use quantitative methods. Limitations such as small sample sizes and short follow-up periods affect many studies. Therefore, further research with larger samples and a longer follow-up period, employing a mixed-methods approach is suggested. This protocol was designed to evaluate the efficacy of the use of intensive care unit diaries for patients and families, as well as to understand professionals’ experiences and satisfaction with intensive care unit diaries.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethod/Design:\u003c/strong\u003e Mixed-method study: a quantitative phase followed by a qualitative phase.\u003c/p\u003e\n\u003cp\u003ePhase 1: Randomised, parallel, non-blinded, multicentre clinical trial, with an experimental group (diary) and a control group (no diary), to identify the efficacy of the diary in improving quality of life and preventing post-traumatic stress and anxiety/depression in patients and family. Measurement tools include the SF-36 Health Questionnaire, EIE-R scale, and HADS scale, administered 2-, 6- and 12-months post-discharge. Each group comprises 120 cases. Data analysis will use IBM-SPSS (v.24) To evaluate the satisfaction of professionals a survey will be carried out.\u003c/p\u003e\n\u003cp\u003ePhase 2: Hermeneutic phenomenological study with theoretical sampling. Size of\u0026nbsp;38-72\u0026nbsp;patients/family members until theoretical data saturation is reached. Data collection from in-depth interviews and field diary 6 months after discharge. Phenomenological analysis according to Smith. Guba and Lincoln’s rigour criteria.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e This research will provide knowledge regarding the benefits and limitations of the use of diaries, based on quantitative and qualitative data, and will promote reflection on their implementation, considering patients, family, and professionals. This study will provide new knowledge about the satisfaction of professionals with diary implementation. This multicentre study will provide valuable information on the contribution of diaries in clinical practice and their impact on patient recovery and the experiences of families and professionals. If the efficacy of the diary is confirmed, it will mark a significant advancement in the care of critically ill patients, contributing to the expansion of their use.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u0026nbsp;\u003c/strong\u003eClinicalTrials.gov Identifier: NCT05288140. 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