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NCT Number: NCT07244718

Investigation of The Effect of Progressive Muscle Relaxation Technique in Sedentary Obese Women

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.

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Key information

Conditions

Progressive Muscle Relaxation Technique Body Weight Dyssomnias Mental Disorders Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Control

Other

No therapeutic intervention will be performed on participants in the control group after baseline assessment. To equalize the time and attention provided to the intervention group, participants in the control group will be asked to lie down in a comfortable position for twenty to thirty minutes once a day before going to bed for six weeks, without engaging in any relaxation technique or physical activity. They will be instructed to record these daily sessions in an activity log and will be asked not to miss more than two sessions per week.

Participants will also be asked to refrain from receiving any additional complementary therapies that promote relaxation-such as acupuncture, massage, and other mind-body techniques-throughout the study period. No restrictions will be placed on their usual daily routines or lifestyle habits.

After completion of all study assessments, participants in the control group will be informed about progressive muscle relaxation techniques, including their a

Music-Assisted Progressive Muscle Relaxation

Other

At the beginning of the study, participants will be verbally informed about the progressive muscle relaxation technique, its application steps, and associated breathing techniques. Following this introduction, twenty- to thirty-minute video and audio recordings prepared by the Turkish Psychologists Association-featuring music-assisted progressive muscle relaxation instructions-will be sent to participants via a smartphone application.

Participants will be instructed to follow the video/audio recordings once a day, before going to bed, for a period of six weeks. Approximately two weeks after the initial meeting, a follow-up session will be scheduled to assess participants' adherence to the protocol and to address any questions or difficulties they may have.

Throughout the intervention period, participants will be asked to document each session in an activity log and will be instructed not to skip more than two sessions per week. They will also be asked to refrain from receiving any ad

Primary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: 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.

  2. Nottingham Health Profile

    Time frame: 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.

  3. Chalder Fatigue Scale

    Time frame: 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.

  4. Depression Anxiety Stress Scale-21

    Time frame: 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.

  5. Epworth Sleepiness Scale

    Time frame: 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.

Other outcomes

  1. Fatigue Severity Scale

    Time frame: Baseline (Week 0) and Week 6

    The scale contains nine items scored from 1 (strongly disagree) to 7 (strongly agree). The total score is calculated as the mean of all items. Scores <4 indicate absence of fatigue, whereas scores ≥4 indicate clinically relevant fatigue; higher values denote greater fatigue severity.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Effects of Music-Assisted Progressive Muscle Relaxation on Sleep Quality, Fatigue, Emotional Symptoms, and Quality of Life in Sedentary Obese Women

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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