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

NCT07531004 | Active Not Recruiting DMC

• 2 other identifiers: 2025-SBB-0042Bartin University
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Burn (Disorder); Patient

Keywords

Burn; progressive relaxation exercise; Sleep; Anxiety; Body image

Outcome Measures

Primary Outcomes (1)

• State-Trait Anxiety Inventory (STAI)

  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.

  Data collection will be completed within seven months

Secondary Outcomes (1)

• Change in Sleep Quality (Richards-Campbell Sleep Questionnaire) and Change in Body Image (Body Image Scale)

  Baseline and day 7 after intervention initiation

Study Arms (2)

Experimental group

EXPERIMENTAL

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. D

Behavioral: Experimental Group; Behavioral: Progrressive relaxation egsercise

Control Group

NO INTERVENTION

The control group will be compared with the intervention group by applying the pre-test and post-test without any intervention to the control group.

Interventions

Experimental Group BEHAVIORAL

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.

Experimental group

Progrressive relaxation egsercise BEHAVIORAL

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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation in the study
• Aged 18 years or older
• Second-degree burn wound
• Having a smartphone
• Able to use a smartphone
• No reading-writing-hearing-comprehension problems
• Not having a diagnosed mental illness
• Not using regular medications that affect sleep patterns
• Functional ability to participate in Progressive Relaxation exercises
• Patients expected to have a hospital stay of at least 1 week
• Recently admitted (new admission)
• Pain score of 4 or higher according to the NRS pain scale

You may not qualify if:

• Complications after burn surgery
• Being under 18 years of age
• Not having a second-degree burn
• Conditions preventing exercise
• Not owning a smartphone
• Inability to use a smartphone
• Having a diagnosed mental illness
• Regular medication use that would affect sleep patterns
• Willingness to withdraw from the study
• Not having the functional ability to participate in Progressive Relaxation exercises
• Hospital stay duration less than 1 week
• Using opioid medications
• Pain score below 4 on the NRS (Numerical Rating Scale).

Sponsors & Collaborators

• Bartın Unıversity: lead

Study Sites (1)

Bağcılar Eğitim ve Araştırma Hastanesi

Istanbul, Bağcılar, 34200, Turkey (Türkiye)

Location

Related Publications (1)

• Harorani M, Davodabady F, Masmouei B, Barati N. The effect of progressive muscle relaxation on anxiety and sleep quality in burn patients: A randomized clinical trial. Burns. 2020 Aug;46(5):1107-1113. doi: 10.1016/j.burns.2019.11.021. Epub 2019 Dec 18.

  PMID: 31862277 BACKGROUND

MeSH Terms

Conditions

Burns; Anxiety Disorders

Condition Hierarchy (Ancestors)

Wounds and Injuries; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: absent
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: Relaxation is a state that everyone needs in daily life. American doctor Edmund Jacobson defined this concept in the 1920s and developed the "Progressive Muscle Relaxation Exercises." Jacobson stated that relaxation could be achieved by reducing muscle tension. Progressive relaxation exercises aim to reduce the sensation of tension by tensing and relaxing major muscle groups. This technique can be effective in reducing muscle tension associated with negative emotions and psychosomatic illnesses. Clinical psychologists and nurses, among other professionals, can easily teach these exercises. The exercises typically last 20-30 minutes with a CD or audio recording. Progressive Relaxation Exercises should be performed in a calm environment away from distractions, with instructions to sequentially tense and relax specific muscle groups. Progressive Relaxation exercises are an increasingly accepted example of non-pharmacological treatment. The aim of progressi

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: April 15, 2026
• Study Start: September 8, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)