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临床试验/NCT07531004
NCT07531004进行中(未招募)不适用

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

Bartın Unıversity1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2025年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1
试验地点
1
主要终点
State-Trait Anxiety Inventory (STAI)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

盲法说明

absent

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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).

研究组 & 干预措施

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

干预措施: Experimental Group (Behavioral)

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

干预措施: Progrressive relaxation egsercise (Behavioral)

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.

结局指标

主要结局

State-Trait Anxiety Inventory (STAI)

时间窗: 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.

次要结局

  • Change in Sleep Quality (Richards-Campbell Sleep Questionnaire) and Change in Body Image (Body Image Scale)(Baseline and day 7 after intervention initiation)

研究者

发起方
Bartın Unıversity
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Tayyip KOÇAK

Student

Bartın Unıversity

研究点 (1)

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