Effects of Music-Assisted Progressive Muscle Relaxation on Sleep Quality, Fatigue, Emotional Symptoms, and Quality of Life in Sedentary Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
Obesity is a major public health problem that reduces quality of life and increases the risk of many chronic diseases. Its global prevalence continues to rise, and it is estimated that approximately 18 percent of men and 21 percent of women will be affected by the year 2025. The development and progression of obesity are influenced by individual characteristics such as age, lifestyle, and gender. Women experience hormonally driven changes in body fat across different life stages, including puberty, reproductive years, and the postpartum period, which place them at higher metabolic risk.
Progressive muscle relaxation, particularly when combined with music, has been shown to reduce sleep problems, emotional disturbances, fatigue, and limitations in quality of life across different clinical populations. However, the effectiveness of music-assisted progressive muscle relaxation in sedentary obese women has not been clearly demonstrated.
This study investigates whether a six-week, home-based music-assisted progressive muscle relaxation program can improve sleep quality, emotional well-being, fatigue, and health-related quality of life in sedentary obese women. The intervention can be performed independently in the participants' own living environment, which supports sustainability and enhances self-management. Demonstrating the effectiveness of this method may offer healthcare professionals a low-cost, accessible, non-pharmacological treatment option to improve both physical and emotional well-being in this high-risk population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18-50 years
- •Classified as sedentary according to the International Physical Activity Questionnaire-Short Form (IPAQ-SF)
- •Obese, defined as BMI ≥ 30 kg/m²
- •Ability to understand written and spoken Turkish
- •Ability to comprehend study instructions
- •Active use of WhatsApp or Telegram to receive intervention materials
排除标准
- •Cognitive impairment affecting communication
- •Pregnancy, postpartum period, or lactation
- •Use of weight-loss medications or sedative-hypnotic drugs
- •Not having a regular menstruation cycle
- •Hearing impairment
- •Criteria for Withdrawal:
- •Voluntary withdrawal from the study
- •Development of a condition preventing continuation of participation
- •Failure to attend sessions regularly (missing more than two sessions per week)
- •Incomplete final assessments
研究组 & 干预措施
Control group
Participants in the control group will not receive any therapeutic intervention during the study period. To equalize the time and attention provided to the intervention group, participants will be instructed to lie down in a comfortable position for twenty to thirty minutes once a day, before going to bed, for a total of six weeks, without performing any relaxation technique or physical activity.
They will be asked to record each daily session in an activity log and will be instructed not to miss more than two sessions per week. Participants will also be asked to refrain from receiving any additional complementary or mind-body therapies that promote relaxation-such as acupuncture, massage, meditation, or other similar practices-throughout the study period. No restrictions will be placed on their usual daily routines or lifestyle habits.
After completion of all assessments at the end of the study, participants in the control group will be provided with information about progressive m
干预措施: Control (Other)
Intervention group
At the beginning of the study, participants will be verbally informed about the progressive muscle relaxation technique, its method of application, and associated breathing techniques. Following this introductory session, twenty- to thirty-minute video and audio recordings prepared by the Turkish Psychologists Association, featuring music-assisted progressive muscle relaxation exercises, will be delivered to participants via a smartphone application.
Participants will be instructed to follow the video and audio recordings once a day, before going to bed, for a period of six weeks. A follow-up meeting will be scheduled two weeks after the initial session to monitor participant compliance, answer questions, and reinforce proper technique.
Participants will be asked to record each session in an activity log and will be instructed not to skip more than two sessions per week. In addition, they will be asked to refrain from receiving any complementary or relaxation-based therapies, such a
干预措施: Music-Assisted Progressive Muscle Relaxation (Other)
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: Baseline (Week 0) and Week 6
The scale designed to assess sleep quality consists of a total of 24 questions. Nineteen of these questions are answered by the individual, while five are answered by their spouse or roommate. The last five questions are not included in the scoring. The total scale score, ranging from 0 to 21, is obtained by summing the scores of seven subcomponents classified as subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, sleep medication use, and daytime dysfunction. A total score of ≤5 indicates good sleep quality, while a score \>5 indicates impaired sleep quality.
Nottingham Health Profile
时间窗: Baseline (Week 0) and Week 6
The Nottingham Health Profile aims to assess quality of life. It is divided into two sections. The first section consists of six sub-dimensions and 38 items: pain, emotional reactions, sleep, social isolation, physical activity, and energy level. Each sub-dimension score ranges from 0 to 100, and the total score for the first section ranges from 0 to 600. The second section consists of seven items containing questions about areas of life affected by health status. The total score for the second section ranges from 0 to 7. In the evaluation of the scale, low scores are interpreted as minimal impact from the disease, while high scores indicate significant impact.
Chalder Fatigue Scale
时间窗: Baseline (Week 0) and Week 6
The Chalder Fatigue Scale assesses the fatigue experienced by individuals over the past month. It consists of 11 items. A high total score on the scale indicates a high level of fatigue.
Depression Anxiety Stress Scale-21
时间窗: Baseline (Week 0) and Week 6
The Depression Anxiety Stress-21 Scale is a shortened version of the Depression Anxiety Stress-42 Scale. It consists of seven items measuring depression, stress, and anxiety. The scale cannot be expressed as a single score; the scores from the three subscales are evaluated separately.
Epworth Sleepiness Scale
时间窗: Baseline (Week 0) and Week 6
It was developed to assess the general level of daytime sleepiness during different daily activities. The scale consists of 8 items scored from 0 to 3. The scale score ranges from 0 to 24. The total score of the scale is positively correlated with the person's daytime sleepiness.
次要结局
未报告次要终点
研究者
Raziye Şavkın
Assoc. Prof.
Pamukkale University