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Burn (Disorder)Burn PatientsNCT07531004

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

A study testing Experimental Group and Progrressive relaxation egsercise in people with Burn (Disorder) and Patient, run by Bartın Unıversity at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Burn (Disorder), Patient
What is being tested?
Experimental Group and Progrressive relaxation egsercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteTurkey (Türkiye)
Study dates
8 Sep 2025to 30 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Bağcılar Eğitim ve Araştırma Hastanesi

    Istanbul, Bağcılar, 34200

Other trials in Turkey (Türkiye)

About this study

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.

Read more

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.

Read the 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.
Being tested
Experimental Group, Progrressive relaxation egsercise
Keywords
Burn, progressive relaxation exercise, Sleep, Anxiety, Body image
Medical subject headings
Burns, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental GroupBehavioural

    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.

  • Progrressive relaxation egserciseBehavioural

    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.

Study groups in NCT07531004
Study groupRoleWhat they receive
Experimental groupExperimentalThe 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
Receives: Behavioral: Experimental Group; Behavioral: Progrressive relaxation egsercise
Control GroupNo interventionThe control group will be compared with the intervention group by applying the pre-test and post-test without any intervention to the control group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Data collection will be completed within seven months

Secondary outcomes (1)
  1. Change in Sleep Quality (Richards-Campbell Sleep Questionnaire) and Change in Body Image (Body Image Scale)

    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.

    Measured: Baseline and day 7 after intervention initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2026
  2. Study start8 Sep 2025
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
1 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07531004
Sponsor's protocol ID
2025-SBB-0042
Other IDs
Bartin University
Acronym
Burn Patients
Status last verified
Apr 2026
First submitted
7 Sep 2025
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to research ethics considerations and in accordance with personal data protection legislation, patient data will not be shared with third parties or institutions.

Publications

  • 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.

    PubMed 31862277

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Group and Progrressive relaxation egsercise in people with Burn (Disorder) and Patient, run by Bartın Unıversity at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

State-Trait Anxiety Inventory (STAI) (time frame: Data collection will be completed within seven months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07531004, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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