Bağcılar Eğitim ve Araştırma Hastanesi
Istanbul, Bağcılar, 34200, Turkey (Türkiye)
NCT Number: NCT07531004
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Istanbul, Bağcılar, 34200, Turkey (Türkiye)
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
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:
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:
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
Hypotheses for Anxiety Levels
Hypotheses for Body Image
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Data collection will be completed within seven months
The State-Trait Anxiety Inventory (STAI) was developed by Spielberger et al. (1970), and the Turkish validity and reliability were established by Oner and Le Compte (1982). In the Turkish adaptation, Cronbach's alpha coefficients range between 0.83 and 0.92 for the State scale and between 0.83 and 0.87 for the Trait scale. Items on the State scale are rated for severity from 1 = "Not at all" to 4 = "Very much so," and items on the Trait scale are rated for frequency from 1 = "Almost never" to 4 = "Almost always." Some items are reverse scored, and total scores for each scale range from 20 to 80, with higher scores indicating higher anxiety levels.
Time frame: Baseline and day 7 after intervention initiation
Mean change in Richards-Campbell Sleep Questionnaire (RCSQ) total score from baseline to day 7 between the intervention (progressive muscle relaxation) and control groups. Higher scores indicate better sleep quality.
Mean change in Body Image Scale total score from baseline to day 7 between the intervention and control groups. Higher scores indicate greater satisfaction with body image.
Bartın Unıversity
Other
Acronym: Burn Patients
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