Effect of a progressive muscle relaxation therapy on reducing anxiety, stress, and improving pregnancy outcome in primigravida women

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Early identification and appropriate management of these psychological factors benefit both the mother and the fetus. This study aimed to evaluate the effectiveness of a progressive muscle relaxation therapy (PMR) in reducing anxiety, stress, and improving pregnancy outcomes among primigravida women in a district of Sri Lanka. Methods A community-based quasi-experimental study was conducted across six Medical Officer of Health areas in the Badulla district, Sri Lanka. Primigravida women between 20 and 28 weeks of gestation, with uncomplicated singleton pregnancies without any pregnancy complications were screened using the Depression Anxiety Stress Scale-21 (DASS-21). Women with elevated anxiety and/or stress were selected through a multi-stage sampling from antenatal clinics and assigned to intervention and control groups based on public health midwife (PHM) clusters. The control group received routine antenatal care, while the intervention group received routine antenatal care plus structured Progressive Muscle Relaxation (PMR) therapy, performed twice daily at home over six weeks. Anxiety and stress levels were assessed at baseline and post-intervention using the DASS-21. Data were analyzed using independent and paired t-tests, and Pearson’s correlation coefficient. Results A total of 288 primigravida women were enrolled (144 per group). At baseline, there were no statistically significant differences in anxiety or stress levels between groups (p > 0.05). Post-intervention, the intervention group showed a significant reduction in both anxiety and stress (anxiety, stress p < 0.001), while the control group demonstrated a significant increase (p < 0.001). Adverse pregnancy outcomes were higher in the control group, including caesarean section/assisted vaginal delivery (Odds Ratio:2.44, 95% Confidence Interval: 1.34–4.46), preterm birth (2.35, 1.31–4.21), prolonged labour (4.93, 1.05–23.27), and neonatal complications (such as birth asphyxia, hypoglycemia, respiratory distress, jaundice, and admissions to the Premature Baby Unit (PBU)) (2.12, 1.03–4.35 ). Conclusions PMR therapy significantly reduced anxiety and stress and improved pregnancy outcomes in primigravida women. Its integration into routine antenatal care, particularly in low-resource settings, offers a cost-effective, non-pharmacological approach to enhancing maternal mental well-being and reducing obstetric and neonatal complications. primigravida anxiety stress progressive muscle relaxation BACKGROUND Pregnancy is a transformative yet challenging period in a woman’s life, particularly for first-time mothers, marked by significant social, physiological, and psychological changes [ 1 ]. Among primigravida women, these changes often contribute to heightened levels of stress and anxiety, which can adversely affect maternal well-being and pregnancy outcomes [ 2 ]. Globally mental health problems in pregnancy are a major public health challenge [ 3 ]. The majority of pregnant women experience a range of psychological disorders, with stress and anxiety, which is commonly reported during pregnancy [ 4 ]. Globally, one in five women experience anxiety during pregnancy [ 5 ] and one in four in LMICs [ 6 ]. Nearly one in three women globally [ 7 ] and more than half of women in LMICs experience stress during pregnancy [ 7 , 8 , 9 , 10 ]. Anxiety and stress during pregnancy have been associated with complications such as preterm birth, low birth weight [ 11 , 12 ], and prolonged labour [ 13 ]. Non-pharmacological interventions, such as relaxation techniques, have garnered increasing attention as effective strategies to alleviate stress and anxiety during pregnancy. Progressive muscle relaxation therapy (PMR) is one such technique that involves systematically tensing and relaxing four major muscle groups in our body [(1) face, (2) neck and shoulders, (3) both hands and arms (4) both legs and feet] in order from the head to feet. It was first developed in 1929 by the Chicago physician Edmund Jacobson [ 14 ] and later manualized in an abbreviated format by Bernstein and Borkovec (1973) [ 15 ] to promote a state of deep relaxation. In some studies PMR therapy has been demonstrated to reduce stress, and anxiety [16, 170] and improve pregnancy outcomes [ 18 ]. Though the mental well-being of antenatal mothers is included as a part of the antenatal care programme in Sri Lanka, a gap in screening and conducting interventions for the early detection of antenatal mental health problems still exists [ 19 ].This study aims to evaluate the effect of PMR therapy on reducing anxiety and stress while improving pregnancy outcomes in primigravida antenatal mothers. METHODS Study design A quasi-experimental study with equal allocation to control and intervention groups. Study Setting The study was conducted from May 2020 to November 2020 in field antenatal clinics and at the household level in 36 clusters (Public Health Midwife Areas) in six Medical Officer of Health (MOH) Areas in Badulla district in Sri Lanka. Eligibility criteria We included primigravida women, aged 18 and above, between 20 to 28 weeks of gestation, with uncomplicated, singleton pregnancies, without any pregnancy complications, and who were screened to have stress and/or anxiety by interviewer-facilitated self-administered Sinhala validated Depression Anxiety Stress Scale-21 (DASS-21) questionnaire with the cutoff values of Anxiety score > 16 and stress score > 20 [ 20 ]. We excluded primigravida women who were diagnosed with any psychiatric illness, any physical or learning disability, practicing any other relaxation technique, and associated with any pregnancy complications. Informed written consent was obtained from the participants at the recruitment stage. The gestational age range was selected for several reasons: at this stage, participants were typically well-established in their perinatal care; there was sufficient time to implement the six-week Progressive Muscle Relaxation intervention and assess outcomes in primigravida women compared to the first and third trimesters [ 21 ]. Intervention Intervention was the progressive muscle relaxation therapy, which is a non-pharmacological method of reducing anxiety and stress. Public Health Midwives (PHMs) in the intervention clusters were trained as field facilitators (FF) through a two-day programme that included theoretical and practical components delivered by an occupational therapist. They were provided with a video CD and a booklet in simple Sinhala language to guide PMR delivery. Primigravida women in the intervention group received two group training sessions from the trained facilitators. The first session introduced anxiety and stress in pregnancy and the purpose of PMR; the second focused on learning and practicing PMR, which involves tensing and relaxing four major muscle groups in coordination with breathing. Participants received the same video CD and booklet and were advised to practice PMR at home twice daily for six weeks. They maintained a practice diary, and adherence was supported through periodic home visits by the facilitators and principal investigator. The control group received routine antenatal care. Outcome Measures The major primary outcome measures were anxiety and stress levels of the primigravida women in both groups. At the end of the six-week duration of PMR therapy, the participants of the intervention and control groups completed the DASS-21 questionnaire as the posttest. Secondary outcome measures, the pregnancy outcomes – mode of delivery, preterm birth, prolonged labour, Apgar score < 5 at 5 minutes, post-partum complications of the mother (such as infected lower segment cesarean section scar, infected episiotomy), neonatal complications (such as birth asphyxia, hypoglycemia, respiratory distress, neonatal jaundice, and PBU admissions) were measured at one month post-partum with an interviewer-administered questionnaire. Sample Size Calculation and selection of participants Based on the study conducted in 2014 in Greece by Tragea et al. [ 22 ], which reported a mean difference in antenatal stress score following progressive muscle relaxation (µ1 = -3.68, µ2 = -0.45), the required sample size was calculated. A total of 288 primigravida women were included, with 144 in the intervention group and 144 in the control group. A quasi-experimental design was used with a multi-stage sampling approach to select participants. First, the 16 Medical Officer of Health (MOH) areas in Badulla district (n = 16) were stratified into two geographic parts: North and South. From each part, three MOH areas were purposively selected based on accessibility and feasibility for intervention delivery. All Public Health Midwife (PHM) areas within each selected MOH were listed, and a total of 18 PHM areas were selected (9 per group) to serve as clusters. Within each cluster (PHM area) 8 eligible primigravida women were selected through simple random sampling based on pre-defined inclusion criteria. The intervention was assigned to PHM areas in one region (eg, South), and the control group was selected from PHM areas in the other region (eg, North), thereby minimizing the risk of contamination between groups. This allocation method ensured comparability while reflecting real-world constraints where full randomization was not feasible. Statistical Analysis Data were analyzed using descriptive and inferential statistics. Descriptive statistics summarized the socio-demographic characteristics of the study participants. For primary outcome measures, pre- and post-intervention mean scores of anxiety and stress in both the intervention and control groups were compared using paired ‘t’ test, independent ‘t’ test, and Chi-square test. For secondary outcome measures, variables such as mode of delivery, preterm birth, prolonged labour, Apgar score, post-partum complications of the mother, and neonatal complications were measured in each group. The Chi-square test was applied to compare these outcomes between the two groups. Additionally, crude odds ratios (COR) with 95% confidence intervals (CI) were calculated, and the significance level was set at p < 0.05. RESULTS Out of the calculated sample size of 144 in the intervention group; 5 participants withdrew from the study either due to difficulties in adhering to the PMR therapy on a regular basis or due to relocation from the study area accounting for a 96.5% response rate for the intervention group (N = 139). In the control group out of 144, 10 withdrew from the control group either due to loss to follow up or due to relocation from the study area, giving 93.1% response rate in the control group (N = 134). Table 1 presents the demographic characteristics of participants in the intervention and control groups. The mean age in the two groups (24.22 years in the intervention and 24.88 years in the control) was not statistically significant (p = 0.24). Most participants were married (over 96%). Educational achievement, income, and employment status were also comparable. Table 1 Demographic characteristics of the study participants Demographic Variables Intervention Group (n = 139) Control Group (n = 134) Age (y)* 24.22 (4.16) 24.88 (5.08) Marital Status Married 135 (97.1) 129 (96.3) Unmarried 4 (2.9) 5 (3.7) Highest Educational achievement** Up to GCE O/L Passed 87 (62.6%) 81 (60.5%) Above GCE A/L 52 (37.4%) 53 (39.5%) Total monthly income** Less than Rs 30000 63 (45.4%) 66 (49.3%) More than Rs 30000 76 (54.6%) 68 (50.7%) Occupation** Unemployed 116 (83.5%) 107 (79.9%) Employed 23 (16.5%) 27 (20.1%) *Mean (SD) **Frequency (Percentage) Table 2 Comparison of Intervention and Control groups by Anxiety and Stress Scores at Pre and Post intervention stages Character Intervention Group (n = 139) Control Group (n = 134) Pre-Intervention Stage Mean Anxiety Score 18.47 (5.23) * 17.42 (5.67) * Mean Difference = 1.05 t = 1.602, p = 0.11 Not statistically significant Mean Stress Score 19.53 (5.84) * 18.34 (6.49) * Mean Difference = 1.19 t = 1.58, p = 0.115 Not statistically significant Post-Intervention Stage Mean Anxiety Score 12.59 (4.58) * 20.52 (5.89) * Mean Difference = -7.93 t = -12.442, p < 0.001 Statistically Significant Mean Stress Score 13.01 (5.22) * 21.72 (6.36) * Mean Difference = -8.71 t = -12.342, p < 0.001 Statistically Significant *Mean (SD) Table 2 describes the means and standard deviations (SD) of anxiety and stress levels in pre-post intervention stages. There were no significant differences in anxiety or stress scores between the two groups at the pre-intervention stage (p = 0.11 and 0.115, respectively). At the post-intervention stage, both anxiety and stress scores showed a significant decrease in the intervention group compared with the control group (p < 0.001). However, in the control group at the post-intervention stage both anxiety and stress scores showed a significant increase, and it was statistically significant (p < 0.001). Table 3 Comparison of pregnancy outcomes in the two groups Pregnancy outcomes Control group (n = 134) Intervention group (n = 139) Total (n = 273) COR 95% CI Significance No. (%) No. (%) No. (%) Mode of delivery Assisted delivery/LSCS # 39 (66.1) 20 (33.9) 59(100) 2.44 (1.34,4.46) χ2 = 8.72 NVD *, ## 95 (44.4) 119 (55.6) 214(100) 1.00 df = 1, p = 0.003 Preterm birth χ2 = 8.38 df = 1, p = 0.004 37weeks* 93 (44.3) 117 (55.7) 210(100) 1.00 Apgar score 5* 124(48.2) 133 (51.8) 257(100) 1.00 Prolonged labour Yes 9 (81.8) 2 (18.2) 11(100) 4.93 (1.05,23.27) χ2 = 4.91 df = 1, p = 0.027 No * 125(47.7) 137(52.3) 262(100) 1.00 Post-partum complications of the mother Yes 23 (57.5) 17 (42.5) 40(100) 1.49 (0.76,2.93) χ2 = 1.33 df = 1, p = 0.25 No * 111(47.6) 122 (52.4) 233(100) 1.00 Neonatal complications χ2 = 4.27 df = 1, p = 0.04 Yes 24(64.9) 13 (35.1) 37(100) 2.12 (1.03,4.35) No* 110(46.6) 126 (53.4) 236(100) 1.00 *-Reference category, # LSCS-Lower Segment Caesarean section, ## NVD-Normal vaginal delivery When pregnancy outcomes were considered; caesarean section or assisted vaginal delivery (OR = 2.44; 95% CI = 1.34, 4.46), preterm delivery (OR = 2.35; 95% CI = 1.31, 4.21), prolonged labour (OR = 4.93; 95% CI = 1.05, 23.27) and neonatal complications (such as birth asphyxia, hypoglycemia, respiratory distress, jaundice, and PBU admissions) (OR = 2.12; 95% CI = 1.03, 4.35) showed significantly higher in the control group than the intervention group. Whereas the baby’s Apgar score < 5 at 5 minutes and post-partum complications of the mother were not statistically significant in the intervention group compared to the control group (Table 3 ). DISCUSSION In this study, the results showed a significant reduction in anxiety and stress, as well as improved pregnancy outcomes especially in mode of delivery towards normal vaginal delivery, gestation at birth towards term, reduction of labour time, and lowering the post-natal complications of the babies in the intervention group compared to the control group (Tables 2 & 3 ). These results indicate the effectiveness of PMR therapy in pregnant women with anxiety and stress. It is noteworthy to say that in this study, PMR therapy was applied for a six-week duration and assessed the anxiety and stress levels in primigravida women in pre- and post-intervention stages. Similar, applications were found in the studies done by Rajeswary & SanjeevaReddy [ 18 ], Nasiri et al. [ 17 ], and Tragea et al. [ 22 ]. In a recent systematic review done by Abera [ 8 ], also found that relaxation interventions could improve maternal stress, anxiety, and pregnancy and birth outcomes. In our study at the pre-intervention stage, there was no statistically significant difference in anxiety and stress levels in both groups similar to studies done in India [ 18 ] and Iran [ 17 , 16 ]. At the post-intervention stage, when comparing the mean anxiety scores between the two groups, it was highly statistically significant, which aligns with the Indian [ 18 ] and Iranian study [ 21 ].When considering the pregnancy outcomes, the mode of delivery—assisted vaginal and LSCS—was statistically significant in the control group, occurring twice as often between the two groups, which similarly reported as statistically significant in the Indian [ 18 ] and Iranian study[ 21 ]. In our study, there was a significant difference between the two groups in delivery of preterm birth, but in the Iranian study [ 21 ], it was not. But similar findings were observed in the Indian study [ 18 ]. On the contrary, in our study, there was an experience of prolonged labour in control group which statistically significant, but in the Indian study they were not [ 18 ]. However, in our study, we inquired neonatal complications collectively (such as birth asphyxia, hypoglycemia, respiratory distress, jaundice, and PBU admissions). It was found to have a statistically significant between the two groups. In the Indian Study [ 18 ], they studied each factor of neonatal complications separately and they were found to be significant similar to our study. Strengths and limitations of the study This study was a challenging process involving home visits to primigravida women for data collection. PMR therapy was practiced at home using a video CD, and a booklet with images explaining the steps of PMR therapy which was prepared by the PI and given to intervention group women and the FFs. The intervention group primigravida women were supervised by the PI and FFs, reinforced during antenatal clinic visits and weekly telephone reminders, along with motivation to maintain a performance diary. A two-day training session on PMR therapy was given to all the PHMs who served as FFs in the intervention group under the guidance of an occupational therapist from a reputed Teaching Hospital. Similar application method was used by the Indian study [ 18 ]. Another strength in our study was that the PMR therapy training was given to pregnant women in groups at the field antenatal clinics. Group education helps women utilize each other’s experiences (under the control of the researcher) and fosters an intimate and friendly atmosphere, which enhances the effectiveness of PMR therapy. In Bastani et al. study, group education to pregnant women was considered as a factor for increasing confidence, improving mental status, creating a familiar, friendly atmosphere among pregnant women that enhanced the effect of relaxation education [ 21 ]. A limitation of this study was that participants were limited to low-risk primigravida women at 20–28 weeks of gestation. Hence, the extension of the present results to a more diverse group of women, including high-risk pregnant women, is not appropriate. The researcher had no control over pregnancy outcomes as they could be influenced by various other factors such as nutritional and familial factors. The lack of similar studies in the local context makes it difficult to compare findings or validate results with existing literature. Implications for clinicians and future research Clinicians, including obstetricians, midwives, and mental health professionals, should consider integrating progressive muscle relaxation (PMR) therapy into prenatal care for primigravida women as a non-pharmacological intervention to reduce anxiety and stress. By incorporating PMR into routine antenatal education or recommending it as a complementary therapy, healthcare providers can potentially enhance pregnancy outcomes, including reducing the risk of complications associated with maternal anxiety and stress. Training healthcare professionals in guiding and promoting PMR techniques can improve accessibility and adherence, ultimately supporting maternal well-being and fetal health. Future guidelines should emphasize the role of PMR as part of a holistic approach to prenatal mental health care. Future research should explore the long-term effects of PMR therapy on maternal and neonatal outcomes beyond pregnancy, including postpartum mental health, infant development, and maternal-infant bonding. Additionally, studies comparing the effectiveness of progressive muscle relaxation with other non-pharmacological interventions, such as mindfulness-based stress reduction or cognitive-behavioral therapy, could provide deeper insights into optimal anxiety and stress management strategies for primigravida women. CONCLUSION The study demonstrates that progressive muscle relaxation therapy is an effective intervention for reducing anxiety and stress in primigravida women. The findings also indicate that incorporating this non-invasive and easily implementable therapy into antenatal care can contribute to improved pregnancy outcomes, including reduced risk of complications and enhanced maternal well-being. These results highlight the importance of stress management techniques in promoting positive maternal and fetal health during pregnancy. Declarations Ethics approval and consent to participate The Postgraduate Institute of Medicine, University of Colombo (ERC/PGIM/2018/125) granted the study's ethical approval. Informed written consent was obtained from each participant at the recruitment stage. Care was taken to ensure the confidentiality of the data. Consent for publication: All participants provided informed written consent for publication of anonymized data. No identifiable personal information is included in this manuscript. Availability of data and materials All datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Competing interests: The authors declare that they have no competing interests. Funding: This research was funded by the University of Sri Jayewardenepura, Sri Lanka, with the grant number ASP/01/RE/MED/2019/42 for the conducting phase. However, there was no funding available for data entry, data analysis, or publication. Author Contributions LN, SG, DW, and RK planned the study. LN and RK collected and analyzed the data. LN performed the statistical analysis and drafted the manuscript. SG, DW, and NS supervised the research, discussed the results, and refined the manuscript. All authors have approved the final manuscript. Acknowledgments: We would like to acknowledge the valuable contributions of our study participants, the public health team, and all the contributors to the study in many ways. ORCID iDs Chamendi Nishshankahttps://orcid.org/0009-0006-6055-551X Sampatha Goonewardena https://orcid.org/ 0000-0002-3368-7959 Dulshika Waas https://orcid.org/0000-0002-3214-2674 Rohan Kulathunga https://orcid.org/0009--0000-5296-5099 Nimal Gamagedara https://orcid.org/0000-0002-0339-0724 References Darvill R, Skirton H, Farrand P. Psychological factors that impact on women’s experiences of first-time motherhood: A qualitative study of the transition. Midwifery. 2010;26:357–66. Kopelman R, Stuart S. Psychiatric disorders in pregnancy 2021. License: CC BY-NC-ND 4.0, In book: Clinical Maternal-Fetal Medicine Online (pp 28.1–28.8) 10.1201/9781003222590-26 World Health Organization Mental Health., brain health and substance use, 2025 https://www.who.int/teams/mental-health-and-substance-use/promotion-prevention/maternal-mental-health Tang X, Lu Z, Hu D, Zhong X. Influencing factors for prenatal Stress, anxiety and depression in early pregnancy among women in Chongqing, China. 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Antenatal depression in Anuradhapura, Sri Lanka and the Factor structure of the Sinhalese version of Edinburgh Postpartum Depression Scale among pregnant women. PLoS ONE. 2013;8(7). 10.1371/journal.pone.0069708 . Deerasinghe DSAF. Prevalence of depression Anxiety and Stress among women aged 40 to 55 years according to menopausal status and risk factors of Depression in Menopausal Women in the district of Colombo Sri Lanka (Doctorial Thesis) Post Graduate Institute of Medicine, Colombo, Sri Lanka, 2014. Bastani F, Hidarnia A, Montgomery KS, Aguilar-Vafaei ME, Kazemnejad A. Does relaxation education in anxious primigravid Iranian women influence adverse pregnancy outcomes? A randomized controlled trial. J Perinat Neonatal Nurs. 2006;20:138–46. 10.1097/00005237-200604000-00007 . Tragea C, Chrousos GP, Alexopoulos EC, Darviri C. A Randomized control trial of the effects of a stress management programme during pregnancy. Sci Direct. 2014;22:203–11. 10.1016/j.ctim.2014.01.006 . Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Reviewers agreed at journal 04 Sep, 2025 Reviewers invited by journal 02 Sep, 2025 Editor invited by journal 04 Aug, 2025 Editor assigned by journal 01 Aug, 2025 Submission checks completed at journal 01 Aug, 2025 First submitted to journal 30 Jul, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7252673","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":510282512,"identity":"bfeef2c3-d7d5-4d38-b528-9e8e4bf514f9","order_by":0,"name":"Lakshrieni Nishshanka","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA7UlEQVRIie3PIQvCQBTA8TsOlgZrMsEPsaT4WSw7BC2exbKgY0mLH0BQ9CtoWb7x4CwDq2DZislgkgWDzyURNmcTvH94XHg/7o4Qne43o5JI4hKGR9fDwVjw0byQ+EloVZJfOM1nOWnVIJFZ7A9bM6aSdD3pWDMkmRcWkvay50TzI4waYPQdHu7FAmhA5/GpkDinAZHmVfIFM5s2D5UIkDA6LSfR/eojsW42XymxqULAPLLnLYbNg7HYfiY9BxoxIDGatquk2CGJyv/STdOLwodZcK5nY1+sDxAlmVdM3oN8ysr7mP/Nsk6n0/1JDzBJY0/eCaB4AAAAAElFTkSuQmCC","orcid":"","institution":"Ministry of Health","correspondingAuthor":true,"prefix":"","firstName":"Lakshrieni","middleName":"","lastName":"Nishshanka","suffix":""},{"id":510282513,"identity":"a67712b5-1e1b-4333-8154-7c3fa5222eaf","order_by":1,"name":"Sampatha Goonewardena","email":"","orcid":"","institution":"University of Sri Jayewardenepura","correspondingAuthor":false,"prefix":"","firstName":"Sampatha","middleName":"","lastName":"Goonewardena","suffix":""},{"id":510282514,"identity":"042773a5-f17f-4155-91b5-26c7009bc8ca","order_by":2,"name":"Dulshika Waas","email":"","orcid":"","institution":"University of Sri Jayewardenepura","correspondingAuthor":false,"prefix":"","firstName":"Dulshika","middleName":"","lastName":"Waas","suffix":""},{"id":510282515,"identity":"52952931-f8e9-41a2-8c1d-3f93bbb7e5ee","order_by":3,"name":"Rohan Kulathunga","email":"","orcid":"","institution":"University of Sri Jayewardenepura","correspondingAuthor":false,"prefix":"","firstName":"Rohan","middleName":"","lastName":"Kulathunga","suffix":""},{"id":510282516,"identity":"31c431ba-a2b3-4924-a3f6-6c4fb03386b6","order_by":4,"name":"Nimal Gamagedara","email":"","orcid":"","institution":"Ministry of Health","correspondingAuthor":false,"prefix":"","firstName":"Nimal","middleName":"","lastName":"Gamagedara","suffix":""}],"badges":[],"createdAt":"2025-07-30 12:08:22","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7252673/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7252673/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":90758113,"identity":"59eb5b13-4a84-4639-9c38-eeb984826541","added_by":"auto","created_at":"2025-09-07 14:11:57","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":844586,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7252673/v1/b803e976-7e69-4ae2-9b2f-48e9734a0f12.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effect of a progressive muscle relaxation therapy on reducing anxiety, stress, and improving pregnancy outcome in primigravida women","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003ePregnancy is a transformative yet challenging period in a woman’s life, particularly for first-time mothers, marked by significant social, physiological, and psychological changes [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Among primigravida women, these changes often contribute to heightened levels of stress and anxiety, which can adversely affect maternal well-being and pregnancy outcomes [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Globally mental health problems in pregnancy are a major public health challenge [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. The majority of pregnant women experience a range of psychological disorders, with stress and anxiety, which is commonly reported during pregnancy [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Globally, one in five women experience anxiety during pregnancy [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] and one in four in LMICs [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Nearly one in three women globally [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] and more than half of women in LMICs experience stress during pregnancy [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Anxiety and stress during pregnancy have been associated with complications such as preterm birth, low birth weight [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], and prolonged labour [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eNon-pharmacological interventions, such as relaxation techniques, have garnered increasing attention as effective strategies to alleviate stress and anxiety during pregnancy. Progressive muscle relaxation therapy (PMR) is one such technique that involves systematically tensing and relaxing four major muscle groups in our body [(1) face, (2) neck and shoulders, (3) both hands and arms (4) both legs and feet] in order from the head to feet. It was first developed in 1929 by the Chicago physician Edmund Jacobson [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] and later manualized in an abbreviated format by Bernstein and Borkovec (1973) [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] to promote a state of deep relaxation. In some studies PMR therapy has been demonstrated to reduce stress, and anxiety [16, 170] and improve pregnancy outcomes [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThough the mental well-being of antenatal mothers is included as a part of the antenatal care programme in Sri Lanka, a gap in screening and conducting interventions for the early detection of antenatal mental health problems still exists [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e].This study aims to evaluate the effect of PMR therapy on reducing anxiety and stress while improving pregnancy outcomes in primigravida antenatal mothers.\u003c/p\u003e\u003cdiv id=\"Sec2\" class=\"Section2\"\u003e\u003cp\u003e\u003c/p\u003e\u003cdiv class=\"BlockQuote\"\u003e\u003c/div\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e"},{"header":"METHODS","content":"\u003cp\u003e\u003cb\u003eStudy design\u003c/b\u003e\u003c/p\u003e\u003cp\u003eA quasi-experimental study with equal allocation to control and intervention groups.\u003c/p\u003e\u003cp\u003e\u003cb\u003eStudy Setting\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe study was conducted from May 2020 to November 2020 in field antenatal clinics and at the household level in 36 clusters (Public Health Midwife Areas) in six Medical Officer of Health (MOH) Areas in Badulla district in Sri Lanka.\u003c/p\u003e\u003cp\u003e\u003cb\u003eEligibility criteria\u003c/b\u003e\u003c/p\u003e\u003cp\u003eWe included primigravida women, aged 18 and above, between 20 to 28 weeks of gestation, with uncomplicated, singleton pregnancies, without any pregnancy complications, and who were screened to have stress and/or anxiety by interviewer-facilitated self-administered Sinhala validated Depression Anxiety Stress Scale-21 (DASS-21) questionnaire with the cutoff values of Anxiety score \u0026gt; 16 and stress score \u0026gt; 20 [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. We excluded primigravida women who were diagnosed with any psychiatric illness, any physical or learning disability, practicing any other relaxation technique, and associated with any pregnancy complications. Informed written consent was obtained from the participants at the recruitment stage.\u003c/p\u003e\u003cp\u003eThe gestational age range was selected for several reasons: at this stage, participants were typically well-established in their perinatal care; there was sufficient time to implement the six-week Progressive Muscle Relaxation intervention and assess outcomes in primigravida women compared to the first and third trimesters [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e\u003cp\u003e\u003cb\u003eIntervention\u003c/b\u003e\u003c/p\u003e\u003cp\u003eIntervention was the progressive muscle relaxation therapy, which is a non-pharmacological method of reducing anxiety and stress. Public Health Midwives (PHMs) in the intervention clusters were trained as field facilitators (FF) through a two-day programme that included theoretical and practical components delivered by an occupational therapist. They were provided with a video CD and a booklet in simple Sinhala language to guide PMR delivery.\u003c/p\u003e\u003cp\u003ePrimigravida women in the intervention group received two group training sessions from the trained facilitators. The first session introduced anxiety and stress in pregnancy and the purpose of PMR; the second focused on learning and practicing PMR, which involves tensing and relaxing four major muscle groups in coordination with breathing. Participants received the same video CD and booklet and were advised to practice PMR at home twice daily for six weeks. They maintained a practice diary, and adherence was supported through periodic home visits by the facilitators and principal investigator. The control group received routine antenatal care.\u003c/p\u003e\u003cp\u003e\u003cb\u003eOutcome Measures\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe major primary outcome measures were anxiety and stress levels of the primigravida women in both groups. At the end of the six-week duration of PMR therapy, the participants of the intervention and control groups completed the DASS-21 questionnaire as the posttest. Secondary outcome measures, the pregnancy outcomes – mode of delivery, preterm birth, prolonged labour, Apgar score \u0026lt; 5 at 5 minutes, post-partum complications of the mother (such as infected lower segment cesarean section scar, infected episiotomy), neonatal complications (such as birth asphyxia, hypoglycemia, respiratory distress, neonatal jaundice, and PBU admissions) were measured at one month post-partum with an interviewer-administered questionnaire.\u003c/p\u003e\u003cp\u003e\u003cb\u003eSample Size Calculation and selection of participants\u003c/b\u003e\u003c/p\u003e\u003cp\u003eBased on the study conducted in 2014 in Greece by Tragea et al. [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e], which reported a mean difference in antenatal stress score following progressive muscle relaxation (µ1 = -3.68, µ2 = -0.45), the required sample size was calculated. A total of 288 primigravida women were included, with 144 in the intervention group and 144 in the control group. A quasi-experimental design was used with a multi-stage sampling approach to select participants. First, the 16 Medical Officer of Health (MOH) areas in Badulla district (n = 16) were stratified into two geographic parts: North and South. From each part, three MOH areas were purposively selected based on accessibility and feasibility for intervention delivery. All Public Health Midwife (PHM) areas within each selected MOH were listed, and a total of 18 PHM areas were selected (9 per group) to serve as clusters. Within each cluster (PHM area) 8 eligible primigravida women were selected through simple random sampling based on pre-defined inclusion criteria. The intervention was assigned to PHM areas in one region (eg, South), and the control group was selected from PHM areas in the other region (eg, North), thereby minimizing the risk of contamination between groups. This allocation method ensured comparability while reflecting real-world constraints where full randomization was not feasible.\u003c/p\u003e\u003ch2\u003eStatistical Analysis\u003c/h2\u003e\u003cp\u003eData were analyzed using descriptive and inferential statistics. Descriptive statistics summarized the socio-demographic characteristics of the study participants. For primary outcome measures, pre- and post-intervention mean scores of anxiety and stress in both the intervention and control groups were compared using paired ‘t’ test, independent ‘t’ test, and Chi-square test.\u003c/p\u003e\u003cp\u003eFor secondary outcome measures, variables such as mode of delivery, preterm birth, prolonged labour, Apgar score, post-partum complications of the mother, and neonatal complications were measured in each group. The Chi-square test was applied to compare these outcomes between the two groups. Additionally, crude odds ratios (COR) with 95% confidence intervals (CI) were calculated, and the significance level was set at p \u0026lt; 0.05.\u003c/p\u003e"},{"header":"RESULTS","content":"\u003cp\u003eOut of the calculated sample size of 144 in the intervention group; 5 participants withdrew from the study either due to difficulties in adhering to the PMR therapy on a regular basis or due to relocation from the study area accounting for a 96.5% response rate for the intervention group (N\u0026thinsp;=\u0026thinsp;139). In the control group out of 144, 10 withdrew from the control group either due to loss to follow up or due to relocation from the study area, giving 93.1% response rate in the control group (N\u0026thinsp;=\u0026thinsp;134). Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e presents the demographic characteristics of participants in the intervention and control groups. The mean age in the two groups (24.22 years in the intervention and 24.88 years in the control) was not statistically significant (p\u0026thinsp;=\u0026thinsp;0.24). Most participants were married (over 96%). Educational achievement, income, and employment status were also comparable.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eDemographic characteristics of the study participants\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDemographic Variables\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIntervention Group (n\u0026thinsp;=\u0026thinsp;139)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eControl Group (n\u0026thinsp;=\u0026thinsp;134)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (y)*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e24.22 (4.16)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e24.88 (5.08)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMarital Status\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMarried\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e135 (97.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e129 (96.3)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUnmarried\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e4 (2.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e5 (3.7)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHighest Educational achievement**\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUp to GCE O/L Passed\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e87 (62.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e81 (60.5%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAbove GCE A/L\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e52 (37.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e53 (39.5%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTotal monthly income**\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLess than Rs 30000\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e63 (45.4%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e66 (49.3%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMore than Rs 30000\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e76 (54.6%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e68 (50.7%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOccupation**\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUnemployed\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e116 (83.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e107 (79.9%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eEmployed\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e23 (16.5%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e27 (20.1%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"3\"\u003e*Mean (SD)\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd colspan=\"3\"\u003e**Frequency (Percentage)\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eComparison of Intervention and Control groups by Anxiety and Stress Scores at Pre and Post intervention stages\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCharacter\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIntervention Group (n\u0026thinsp;=\u0026thinsp;139)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eControl Group (n\u0026thinsp;=\u0026thinsp;134)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePre-Intervention Stage\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean Anxiety Score\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e18.47 (5.23) *\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e17.42 (5.67) *\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eMean Difference\u0026thinsp;=\u0026thinsp;1.05\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003et\u0026thinsp;=\u0026thinsp;1.602, p\u0026thinsp;=\u0026thinsp;0.11\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eNot statistically significant\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean Stress Score\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e19.53 (5.84) *\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e18.34 (6.49) *\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMean Difference\u0026thinsp;=\u0026thinsp;1.19\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003et\u0026thinsp;=\u0026thinsp;1.58, p\u0026thinsp;=\u0026thinsp;0.115\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eNot statistically significant\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePost-Intervention Stage\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean Anxiety Score\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e12.59 (4.58) *\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e20.52 (5.89) *\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eMean Difference = -7.93\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003et = -12.442, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e\u003cb\u003eStatistically Significant\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean Stress Score\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e13.01 (5.22) *\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e21.72 (6.36) *\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMean Difference = -8.71\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003et = -12.342, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e\u003cb\u003eStatistically Significant\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"3\"\u003e*Mean (SD)\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e describes the means and standard deviations (SD) of anxiety and stress levels in pre-post intervention stages. There were no significant differences in anxiety or stress scores between the two groups at the pre-intervention stage (p\u0026thinsp;=\u0026thinsp;0.11 and 0.115, respectively).\u003c/p\u003e\u003cp\u003eAt the post-intervention stage, both anxiety and stress scores showed a significant decrease in the intervention group compared with the control group (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). However, in the control group at the post-intervention stage both anxiety and stress scores showed a significant increase, and it was statistically significant (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eComparison of pregnancy outcomes in the two groups\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"11\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c11\" colnum=\"11\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003ePregnancy outcomes\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eControl group (n\u0026thinsp;=\u0026thinsp;134)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eIntervention group\u003c/p\u003e\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;139)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eTotal\u003c/p\u003e\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;273)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eCOR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"3\" morerows=\"1\" nameend=\"c9\" namest=\"c7\" rowspan=\"2\"\u003e\u003cp\u003e95% CI\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" morerows=\"1\" nameend=\"c11\" namest=\"c10\" rowspan=\"2\"\u003e\u003cp\u003eSignificance\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003eNo. (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eNo. (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eNo. (%)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"11\" nameend=\"c11\" namest=\"c1\"\u003e\u003cp\u003e\u003cem\u003eMode of delivery\u003c/em\u003e\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAssisted delivery/LSCS\u003c/b\u003e\u003csup\u003e\u003cb\u003e#\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e39 (66.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e20 (33.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e59(100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e2.44\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c9\" namest=\"c7\"\u003e\u003cp\u003e(1.34,4.46)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c11\" namest=\"c10\"\u003e\u003cp\u003eχ2\u0026thinsp;=\u0026thinsp;8.72\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNVD\u003csup\u003e\u003cb\u003e*, ##\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e95 (44.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e119 (55.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e214(100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c9\" namest=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c11\" namest=\"c10\"\u003e\u003cp\u003edf\u0026thinsp;=\u0026thinsp;1,\u003c/p\u003e\u003cp\u003e\u003cb\u003ep\u0026thinsp;=\u0026thinsp;0.003\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePreterm birth\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"8\" nameend=\"c9\" namest=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" morerows=\"2\" nameend=\"c11\" namest=\"c10\" rowspan=\"3\"\u003e\u003cp\u003eχ2\u0026thinsp;=\u0026thinsp;8.38\u003c/p\u003e\u003cp\u003edf\u0026thinsp;=\u0026thinsp;1,\u003c/p\u003e\u003cp\u003e\u003cb\u003ep\u0026thinsp;=\u0026thinsp;0.004\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003e\u0026lt; 37 weeks\u003c/em\u003e\u003c/p\u003e \u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e41 (65.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e22 (34.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e63(100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e2.35\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c9\" namest=\"c7\"\u003e\u003cp\u003e(1.31, 4.21)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026gt;37weeks*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e93 (44.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e117 (55.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e210(100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c9\" namest=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"11\" nameend=\"c11\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eApgar score\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026lt; 5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e10 (62.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e6 (37.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e16 (100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1.79\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c9\" namest=\"c7\"\u003e\u003cp\u003e(0.63, 5.06)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" morerows=\"1\" nameend=\"c11\" namest=\"c10\" rowspan=\"2\"\u003e\u003cp\u003eχ2\u0026thinsp;=\u0026thinsp;1.22\u003c/p\u003e\u003cp\u003edf\u0026thinsp;=\u0026thinsp;1,\u003c/p\u003e\u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.27\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026gt;5*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e124(48.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e133 (51.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e257(100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c9\" namest=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"11\" nameend=\"c11\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eProlonged labour\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e9 (81.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e2 (18.2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e11(100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e4.93\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c9\" namest=\"c7\"\u003e\u003cp\u003e(1.05,23.27)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" morerows=\"1\" nameend=\"c11\" namest=\"c10\" rowspan=\"2\"\u003e\u003cp\u003eχ2\u0026thinsp;=\u0026thinsp;4.91\u003c/p\u003e\u003cp\u003edf\u0026thinsp;=\u0026thinsp;1,\u003c/p\u003e\u003cp\u003e\u003cb\u003ep\u0026thinsp;=\u0026thinsp;0.027\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003csup\u003e\u003cb\u003e*\u003c/b\u003e\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e\u003cp\u003e125(47.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e137(52.3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e262(100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e1.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"3\" nameend=\"c9\" namest=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"10\" nameend=\"c10\" namest=\"c1\"\u003e\u003cp\u003e\u003cem\u003ePost-partum complications of the mother\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"1\" nameend=\"c11\" namest=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e23 (57.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003e17 (42.5)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e40(100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e\u003cp\u003e1.49\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e(0.76,2.93)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" morerows=\"1\" nameend=\"c10\" namest=\"c9\" rowspan=\"2\"\u003e\u003cp\u003eχ2\u0026thinsp;=\u0026thinsp;1.33\u003c/p\u003e\u003cp\u003edf\u0026thinsp;=\u0026thinsp;1,\u003c/p\u003e\u003cp\u003ep\u0026thinsp;=\u0026thinsp;0.25\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"1\" nameend=\"c11\" namest=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e111(47.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003e122 (52.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e233(100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e\u003cp\u003e1.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"1\" nameend=\"c11\" namest=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"8\" nameend=\"c8\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eNeonatal complications\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" morerows=\"2\" nameend=\"c10\" namest=\"c9\" rowspan=\"3\"\u003e\u003cp\u003eχ2\u0026thinsp;=\u0026thinsp;4.27\u003c/p\u003e\u003cp\u003edf\u0026thinsp;=\u0026thinsp;1,\u003c/p\u003e\u003cp\u003e\u003cb\u003ep\u0026thinsp;=\u0026thinsp;0.04\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"1\" nameend=\"c11\" namest=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cem\u003eYes\u003c/em\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e24(64.9)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003e13 (35.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e37(100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e\u003cp\u003e2.12\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e(1.03,4.35)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"1\" nameend=\"c11\" namest=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo*\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e110(46.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003e126 (53.4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e236(100)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e\u003cp\u003e1.00\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colspan=\"1\" nameend=\"c11\" namest=\"c11\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"11\"\u003e*-Reference category, \u003csup\u003e#\u003c/sup\u003eLSCS-Lower Segment Caesarean section, \u003csup\u003e##\u003c/sup\u003eNVD-Normal vaginal delivery\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eWhen pregnancy outcomes were considered; caesarean section or assisted vaginal delivery (OR\u0026thinsp;=\u0026thinsp;2.44; 95% CI\u0026thinsp;=\u0026thinsp;1.34, 4.46), preterm delivery (OR\u0026thinsp;=\u0026thinsp;2.35; 95% CI\u0026thinsp;=\u0026thinsp;1.31, 4.21), prolonged labour (OR\u0026thinsp;=\u0026thinsp;4.93; 95% CI\u0026thinsp;=\u0026thinsp;1.05, 23.27) and neonatal complications (such as birth asphyxia, hypoglycemia, respiratory distress, jaundice, and PBU admissions) (OR\u0026thinsp;=\u0026thinsp;2.12; 95% CI\u0026thinsp;=\u0026thinsp;1.03, 4.35) showed significantly higher in the control group than the intervention group. Whereas the baby\u0026rsquo;s Apgar score\u0026thinsp;\u0026lt;\u0026thinsp;5 at 5 minutes and post-partum complications of the mother were not statistically significant in the intervention group compared to the control group (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eIn this study, the results showed a significant reduction in anxiety and stress, as well as improved pregnancy outcomes especially in mode of delivery towards normal vaginal delivery, gestation at birth towards term, reduction of labour time, and lowering the post-natal complications of the babies in the intervention group compared to the control group (Tables\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e \u0026amp; \u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). These results indicate the effectiveness of PMR therapy in pregnant women with anxiety and stress. It is noteworthy to say that in this study, PMR therapy was applied for a six-week duration and assessed the anxiety and stress levels in primigravida women in pre- and post-intervention stages. Similar, applications were found in the studies done by Rajeswary \u0026amp; SanjeevaReddy [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], Nasiri et al. [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], and Tragea et al. [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. In a recent systematic review done by Abera [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e], also found that relaxation interventions could improve maternal stress, anxiety, and pregnancy and birth outcomes.\u003c/p\u003e\u003cp\u003eIn our study at the pre-intervention stage, there was no statistically significant difference in anxiety and stress levels in both groups similar to studies done in India [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] and Iran [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. At the post-intervention stage, when comparing the mean anxiety scores between the two groups, it was highly statistically significant, which aligns with the Indian [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] and Iranian study [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].When considering the pregnancy outcomes, the mode of delivery\u0026mdash;assisted vaginal and LSCS\u0026mdash;was statistically significant in the control group, occurring twice as often between the two groups, which similarly reported as statistically significant in the Indian [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] and Iranian study[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIn our study, there was a significant difference between the two groups in delivery of preterm birth, but in the Iranian study [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e], it was not. But similar findings were observed in the Indian study [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eOn the contrary, in our study, there was an experience of prolonged labour in control group which statistically significant, but in the Indian study they were not [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. However, in our study, we inquired neonatal complications collectively (such as birth asphyxia, hypoglycemia, respiratory distress, jaundice, and PBU admissions). It was found to have a statistically significant between the two groups. In the Indian Study [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], they studied each factor of neonatal complications separately and they were found to be significant similar to our study.\u003c/p\u003e\u003cp\u003e\u003cb\u003eStrengths and limitations of the study\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis study was a challenging process involving home visits to primigravida women for data collection. PMR therapy was practiced at home using a video CD, and a booklet with images explaining the steps of PMR therapy which was prepared by the PI and given to intervention group women and the FFs. The intervention group primigravida women were supervised by the PI and FFs, reinforced during antenatal clinic visits and weekly telephone reminders, along with motivation to maintain a performance diary. A two-day training session on PMR therapy was given to all the PHMs who served as FFs in the intervention group under the guidance of an occupational therapist from a reputed Teaching Hospital. Similar application method was used by the Indian study [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eAnother strength in our study was that the PMR therapy training was given to pregnant women in groups at the field antenatal clinics. Group education helps women utilize each other\u0026rsquo;s experiences (under the control of the researcher) and fosters an intimate and friendly atmosphere, which enhances the effectiveness of PMR therapy. In Bastani et al. study, group education to pregnant women was considered as a factor for increasing confidence, improving mental status, creating a familiar, friendly atmosphere among pregnant women that enhanced the effect of relaxation education [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eA limitation of this study was that participants were limited to low-risk primigravida women at 20\u0026ndash;28 weeks of gestation. Hence, the extension of the present results to a more diverse group of women, including high-risk pregnant women, is not appropriate. The researcher had no control over pregnancy outcomes as they could be influenced by various other factors such as nutritional and familial factors. The lack of similar studies in the local context makes it difficult to compare findings or validate results with existing literature.\u003c/p\u003e\u003cp\u003e\u003cb\u003eImplications for clinicians and future research\u003c/b\u003e\u003c/p\u003e\u003cp\u003eClinicians, including obstetricians, midwives, and mental health professionals, should consider integrating progressive muscle relaxation (PMR) therapy into prenatal care for primigravida women as a non-pharmacological intervention to reduce anxiety and stress. By incorporating PMR into routine antenatal education or recommending it as a complementary therapy, healthcare providers can potentially enhance pregnancy outcomes, including reducing the risk of complications associated with maternal anxiety and stress. Training healthcare professionals in guiding and promoting PMR techniques can improve accessibility and adherence, ultimately supporting maternal well-being and fetal health. Future guidelines should emphasize the role of PMR as part of a holistic approach to prenatal mental health care.\u003c/p\u003e\u003cp\u003eFuture research should explore the long-term effects of PMR therapy on maternal and neonatal outcomes beyond pregnancy, including postpartum mental health, infant development, and maternal-infant bonding. Additionally, studies comparing the effectiveness of progressive muscle relaxation with other non-pharmacological interventions, such as mindfulness-based stress reduction or cognitive-behavioral therapy, could provide deeper insights into optimal anxiety and stress management strategies for primigravida women.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThe study demonstrates that progressive muscle relaxation therapy is an effective intervention for reducing anxiety and stress in primigravida women. The findings also indicate that incorporating this non-invasive and easily implementable therapy into antenatal care can contribute to improved pregnancy outcomes, including reduced risk of complications and enhanced maternal well-being. These results highlight the importance of stress management techniques in promoting positive maternal and fetal health during pregnancy.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Postgraduate Institute of Medicine, University of Colombo (ERC/PGIM/2018/125) granted the study\u0026apos;s ethical approval. Informed written consent was obtained from each participant at the recruitment stage. Care was taken to ensure the confidentiality of the data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u0026nbsp;\u003c/strong\u003eAll participants provided informed written consent for publication of anonymized data. No identifiable personal information is included in this manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u0026nbsp;\u003c/strong\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eThis research was funded by the University of Sri Jayewardenepura, Sri Lanka, with the grant number ASP/01/RE/MED/2019/42 for the conducting phase. However, there was no funding available for data entry, data analysis, or publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLN, SG, DW, and RK planned the study. LN and RK collected and analyzed the data. LN performed the statistical analysis and drafted the manuscript. SG, DW, and NS supervised the research, discussed the results, and refined the manuscript. All authors have approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments:\u0026nbsp;\u003c/strong\u003eWe would like to acknowledge the valuable contributions of our study participants, the public health team, and all the contributors to the study in many ways.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eORCID iDs\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eChamendi Nishshankahttps://orcid.org/0009-0006-6055-551X\u003c/p\u003e\n\u003cp\u003eSampatha Goonewardena https://orcid.org/\u003cu\u003e0000-0002-3368-7959\u003c/u\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDulshika Waas https://orcid.org/0000-0002-3214-2674\u003c/p\u003e\n\u003cp\u003eRohan Kulathunga https://orcid.org/0009--0000-5296-5099\u003c/p\u003e\n\u003cp\u003eNimal Gamagedara https://orcid.org/0000-0002-0339-0724\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eDarvill R, Skirton H, Farrand P. 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A Randomized control trial of the effects of a stress management programme during pregnancy. Sci Direct. 2014;22:203\u0026ndash;11. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.ctim.2014.01.006\u003c/span\u003e\u003cspan address=\"10.1016/j.ctim.2014.01.006\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-pregnancy-and-childbirth","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"prch","sideBox":"Learn more about [BMC Pregnancy and Childbirth](http://bmcpregnancychildbirth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/prch/default.aspx","title":"BMC Pregnancy and Childbirth","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"primigravida, anxiety, stress, progressive muscle relaxation","lastPublishedDoi":"10.21203/rs.3.rs-7252673/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7252673/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eAnxiety and stress during pregnancy are associated with adverse maternal and neonatal outcomes, including prolonged labour, preterm birth, and low birth weight. Early identification and appropriate management of these psychological factors benefit both the mother and the fetus. This study aimed to evaluate the effectiveness of a progressive muscle relaxation therapy (PMR) in reducing anxiety, stress, and improving pregnancy outcomes among primigravida women in a district of Sri Lanka.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eA community-based quasi-experimental study was conducted across six Medical Officer of Health areas in the Badulla district, Sri Lanka. Primigravida women between 20 and 28 weeks of gestation, with uncomplicated singleton pregnancies without any pregnancy complications were screened using the Depression Anxiety Stress Scale-21 (DASS-21). Women with elevated anxiety and/or stress were selected through a multi-stage sampling from antenatal clinics and assigned to intervention and control groups based on public health midwife (PHM) clusters. The control group received routine antenatal care, while the intervention group received routine antenatal care plus structured Progressive Muscle Relaxation (PMR) therapy, performed twice daily at home over six weeks. Anxiety and stress levels were assessed at baseline and post-intervention using the DASS-21. Data were analyzed using independent and paired t-tests, and Pearson\u0026rsquo;s correlation coefficient.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eA total of 288 primigravida women were enrolled (144 per group). At baseline, there were no statistically significant differences in anxiety or stress levels between groups (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05). Post-intervention, the intervention group showed a significant reduction in both anxiety and stress (anxiety, stress p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), while the control group demonstrated a significant increase (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Adverse pregnancy outcomes were higher in the control group, including caesarean section/assisted vaginal delivery (Odds Ratio:2.44, 95% Confidence Interval: 1.34\u0026ndash;4.46), preterm birth (2.35, 1.31\u0026ndash;4.21), prolonged labour (4.93, 1.05\u0026ndash;23.27), and neonatal complications (such as birth asphyxia, hypoglycemia, respiratory distress, jaundice, and admissions to the Premature Baby Unit (PBU)) (2.12, 1.03\u0026ndash;4.35 ).\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e\u003cp\u003ePMR therapy significantly reduced anxiety and stress and improved pregnancy outcomes in primigravida women. Its integration into routine antenatal care, particularly in low-resource settings, offers a cost-effective, non-pharmacological approach to enhancing maternal mental well-being and reducing obstetric and neonatal complications.\u003c/p\u003e","manuscriptTitle":"Effect of a progressive muscle relaxation therapy on reducing anxiety, stress, and improving pregnancy outcome in primigravida women","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-07 13:47:52","doi":"10.21203/rs.3.rs-7252673/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"321345330019984779001347170221048464895","date":"2025-09-04T13:34:39+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-09-02T13:07:32+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-08-04T14:09:50+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-08-01T12:19:43+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-08-01T12:19:27+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Pregnancy and Childbirth","date":"2025-07-30T11:58:19+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-pregnancy-and-childbirth","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"prch","sideBox":"Learn more about [BMC Pregnancy and Childbirth](http://bmcpregnancychildbirth.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/prch/default.aspx","title":"BMC Pregnancy and Childbirth","twitterHandle":"@BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"035aa81c-104b-4fcb-a903-eccc2fb83d28","owner":[],"postedDate":"September 7th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-09-07T13:47:52+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-07 13:47:52","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7252673","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7252673","identity":"rs-7252673","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}