NCT07531004

Effect of Progressive Relaxation Exercises on Sleep, Anxiety, and Body Image in Burn Patients

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (estimated)
• Sponsor: Bartın Unıversity · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Importance of Sleep Quality, Anxiety Levels, and Body Image in Burn Patients Sleep quality, anxiety levels, and body image play a significant role in the recovery process and overall quality of life for burn patients. Good sleep supports the body's repair processes, while poor sleep can delay wound healing. Anxiety negatively impacts emotional well-being, disrupts patient engagement in treatment, and limits social interactions. Similarly, a negative body image undermines self-confidence and adversely affects social relationships. Therefore, managing these factors is critical for the physiological and psychological health of burn patients. Progressive muscle relaxation exercises may have a positive effect on sleep quality, anxiety levels, and body image in burn patients. Given the limited research on this topic, this study has been designed. Purpose of the Study The aim of this study is to examine the effects of progressive muscle relaxation exercises on sleep, anxiety, and body image in burn patients. Research Setting and Timeframe The research will be conducted at the Burn Unit of Bağcılar Training and Research Hospital. The burn unit staff includes 5 doctors, 8 nurses, 1 head nurse, 2 secretaries, and 2 auxiliary staff members. Written permissions will be obtained from Bağcılar Training and Research Hospital and the Bartın University Social and Human Sciences Ethics Committee. After obtaining the necessary approvals, doctors and nurses working in the burn unit will be verbally informed. Patients meeting the inclusion criteria will be informed and asked to sign an "Informed Voluntary Consent Form" (Appendix-6). For the experimental group, a progressive muscle relaxation exercise audio recording, created by the researcher with relaxing nature sounds in the background, will be played. During the first session, the researcher will stay with the patient to provide assistance. Patients in the experimental group will perform the progressive relaxation exercises twice a day, in the morning and evening, for one week. Data collection is planned to take place between March 2025 and November 2025. Population and Sample The study population comprises patients treated at the Burn Unit of Bağcılar Training and Research Hospital. The sample size was determined using G\*Power 3.1.9.7 software based on α = 0.05, 90% power, and an effect size of 0.746 from a similar study. The analysis indicated a required sample size of at least 50 patients in the experimental group and 50 in the control group, totaling 100 patients (Williams et al., 2024). The sample will include patients with second-degree burns covering more than 9% of their total body surface area. To minimize data loss, patients expected to stay hospitalized for at least one week will be included in the study. Only newly admitted patients with a Numerical Rating Scale (NRS) pain score of 4 or higher will be considered. Study Variables * Independent Variable: Progressive muscle relaxation exercises * Dependent Variables: Sleep quality, anxiety levels, body image Methodology Before the study begins, written permissions will be obtained from Bağcılar Training and Research Hospital and Bartın University's Social and Human Sciences Ethics Committee. Patients meeting the inclusion criteria will be informed and asked to complete the "Informed Voluntary Consent Form" (Appendix-6). Progressive muscle relaxation exercises will be taught to the patients, who will be instructed to practice them twice daily, in the morning and evening. Randomization The total sample size for the study is 100 patients. Block randomization will be used, with 25 blocks, each containing 4 patients. Each block will include 2 patients in the experimental group and 2 in the control group. To avoid confusion, each patient will be assigned a unique number from 1 to 100. Example blocks: * Block 1: \[1: E, 2: E, 3: C, 4: C\] * Block 2: \[5: E, 6: E, 7: C, 8: C\] * Block 3: \[9: E, 10: E, 11: C, 12: C\] * Block 25: \[97: E, 98: E, 99: C, 100: C\] In rooms with two patients meeting the inclusion criteria, both will be placed in the same group. Progressive Muscle Relaxation Exercise Application (Appendix-4) Progressive muscle relaxation exercises will be administered to the experimental group following steps outlined by the Turkish Psychological Association. The exercises will be delivered through an audio recording created by the researcher, which includes calming nature sounds in the background. Necessary permissions for creating the audio file will be obtained from the Turkish Psychological Association. Data Collection Tools After completing the "Informed Voluntary Consent Form" (Appendix-6), patients will answer demographic questions regarding their burn degree, burn location, and dressing frequency on the "Patient Identification Form" (Appendix-5). The following scales will be used.

Detailed description

The Importance of Sleep Quality, Anxiety Levels, and Body Image in Burn Patients Sleep quality, anxiety levels, and body image play a significant role in the recovery process and overall quality of life for burn patients. Good sleep supports the body's repair processes, while poor sleep can delay wound healing. Anxiety negatively impacts emotional well-being, disrupts patient engagement in treatment, and limits social interactions. Similarly, a negative body image undermines self-confidence and adversely affects social relationships. Therefore, managing these factors is critical for the physiological and psychological health of burn patients. Progressive muscle relaxation exercises may have a positive effect on sleep quality, anxiety levels, and body image in burn patients. Given the limited research on this topic, this study has been designed. Purpose of the Study The aim of this study is to examine the effects of progressive muscle relaxation exercises on sleep, anxiety, and body image in burn patients. Research Setting and Timeframe The research will be conducted at the Burn Unit of Bağcılar Training and Research Hospital. The burn unit staff includes 5 doctors, 8 nurses, 1 head nurse, 2 secretaries, and 2 auxiliary staff members. Written permissions will be obtained from Bağcılar Training and Research Hospital and the Bartın University Social and Human Sciences Ethics Committee. After obtaining the necessary approvals, doctors and nurses working in the burn unit will be verbally informed. Patients meeting the inclusion criteria will be informed and asked to sign an "Informed Voluntary Consent Form" (Appendix-6). For the experimental group, a progressive muscle relaxation exercise audio recording, created by the researcher with relaxing nature sounds in the background, will be played. During the first session, the researcher will stay with the patient to provide assistance. Patients in the experimental group will perform the progressive relaxation exercises twice a day, in the morning and evening, for one week. Data collection is planned to take place between March 2025 and November 2025. Population and Sample The study population comprises patients treated at the Burn Unit of Bağcılar Training and Research Hospital. The sample size was determined using G\*Power 3.1.9.7 software based on α = 0.05, 90% power, and an effect size of 0.746 from a similar study. The analysis indicated a required sample size of at least 50 patients in the experimental group and 50 in the control group, totaling 100 patients (Williams et al., 2024). The sample will include patients with second-degree burns covering more than 9% of their total body surface area. To minimize data loss, patients expected to stay hospitalized for at least one week will be included in the study. Only newly admitted patients with a Numerical Rating Scale (NRS) pain score of 4 or higher will be considered. Study Variables * Independent Variable: Progressive muscle relaxation exercises * Dependent Variables: Sleep quality, anxiety levels, body image Methodology Before the study begins, written permissions will be obtained from Bağcılar Training and Research Hospital and Bartın University's Social and Human Sciences Ethics Committee. Patients meeting the inclusion criteria will be informed and asked to complete the "Informed Voluntary Consent Form" (Appendix-6). Progressive muscle relaxation exercises will be taught to the patients, who will be instructed to practice them twice daily, in the morning and evening. Randomization The total sample size for the study is 100 patients. Block randomization will be used, with 25 blocks, each containing 4 patients. Each block will include 2 patients in the experimental group and 2 in the control group. To avoid confusion, each patient will be assigned a unique number from 1 to 100. Example blocks: * Block 1: \[1: E, 2: E, 3: C, 4: C\] * Block 2: \[5: E, 6: E, 7: C, 8: C\] * Block 3: \[9: E, 10: E, 11: C, 12: C\] * Block 25: \[97: E, 98: E, 99: C, 100: C\] In rooms with two patients meeting the inclusion criteria, both will be placed in the same group. Progressive Muscle Relaxation Exercise Application (Appendix-4) Progressive muscle relaxation exercises will be administered to the experimental group following steps outlined by the Turkish Psychological Association. The exercises will be delivered through an audio recording created by the researcher, which includes calming nature sounds in the background. Necessary permissions for creating the audio file will be obtained from the Turkish Psychological Association. Data Collection Tools After completing the "Informed Voluntary Consent Form" (Appendix-6), patients will answer demographic questions regarding their burn degree, burn location, and dressing frequency on the "Patient Identification Form" (Appendix-5). The following scales will be used: * Richard-Campbell Sleep Scale (Appendix-2): To assess sleep quality * State-Trait Anxiety Inventory (Appendix-1): To measure anxiety levels * Body Image Scale (Appendix-3): To evaluate patients' perceptions and thoughts about their bodies A progressive relaxation exercise chart (Appendix-7) will track whether patients practice the exercises, and a sleep chart (Appendix-8) will monitor their sleep adequacy. The study will employ a two-group pretest-posttest design. While the control group will continue receiving standard care, the experimental group will additionally practice progressive relaxation exercises. Before the intervention, both groups will complete pretest questionnaires. After the experimental group practices relaxation exercises twice daily for 7 days, posttest questionnaires will be administered. Research Hypotheses Hypotheses for Sleep Quality * H1: Progressive muscle relaxation exercises improve sleep quality in burn patients. * H2: Progressive muscle relaxation exercises do not affect sleep quality in burn patients. Hypotheses for Anxiety Levels * H1: Progressive muscle relaxation exercises reduce anxiety levels in burn patients. * H2: Progressive muscle relaxation exercises do not affect anxiety levels in burn patients. Hypotheses for Body Image * H1: Progressive muscle relaxation exercises improve body image in burn patients. * H2: Progressive muscle relaxation exercises do not affect body image in burn patients. Background and Justification Studies indicate that burn patients often experience high levels of anxiety, which can trigger physiological processes that impair wound healing. Increased anxiety can also lead to sleep deprivation, resulting in delayed recovery, elevated blood pressure, and increased stress hormone levels. Healthy sleep is a vital function influencing recovery and treatment outcomes. Additionally, burn injuries can lead to physiological challenges such as fluid imbalances, hypothermia, and wound infections, as well as psychosocial issues like depression and distorted body image (Ordin \& Sütsünbüloğlu, 2017). Study Goals This thesis aims to: * Clearly explain progressive muscle relaxation exercises to patients and ensure they understand the process. * Assist patients during the exercises to ensure correct practice. * Confirm regular exercise adherence. * Facilitate the accurate and complete completion of measurement tools.

Conditions

• Burn (Disorder)
• Patient

Interventions

Type	Name	Description
BEHAVIORAL	Experimental Group	First, pre-test questions will be asked of and recorded for patients in the intervention group. Next, after completing the pre-test, patients will be taught and instructed to perform progressive muscle relaxation exercises. They will be asked to practice this exercise for one week. At the end of the week, post-test questions will be asked.
BEHAVIORAL	Progrressive relaxation egsercise	First, pre-test questions will be asked of and recorded for patients in the intervention group. Next, after completing the pre-test, patients will be taught and instructed to perform progressive muscle relaxation exercises. They will be asked to practice this exercise for one week. At the end of the week, post-test questions will be asked.

Timeline

• Start date: 2025-09-08
• Primary completion: 2026-04-30
• Completion: 2026-05-30
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: Turkey (Türkiye)