Progressive Muscle Relaxation TechniqueNCT07244718
Investigation of The Effect of Progressive Muscle Relaxation Technique in Sedentary Obese Women
A study testing Music-Assisted Progressive Muscle Relaxation in people with Progressive Muscle Relaxation Technique, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Progressive Muscle Relaxation Technique
- What is being tested?
- Music-Assisted Progressive Muscle Relaxation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Music-Assisted Progressive Muscle Relaxation on Sleep Quality, Fatigue, Emotional Symptoms, and Quality of Life 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.
- Conditions
- Progressive Muscle Relaxation Technique
- Being tested
- Control, Music-Assisted Progressive Muscle Relaxation
- Keywords
- Progressive Muscle Relaxation Technique, Sleep Quality, Mood, Fatique, Quality of Life, Obesity
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
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 RelaxationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | 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 Receives: Other: Control |
| Intervention group | Experimental | 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 Receives: Other: Music-Assisted Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
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.
Measured: Baseline (Week 0) and Week 6
Nottingham Health Profile
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.
Measured: Baseline (Week 0) and Week 6
Chalder Fatigue Scale
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.
Measured: Baseline (Week 0) and Week 6
Depression Anxiety Stress Scale-21
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.
Measured: Baseline (Week 0) and Week 6
Epworth Sleepiness Scale
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.
Measured: Baseline (Week 0) and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Feb 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Muscle Relaxation TechniqueStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raziye Şavkın, Pamukkale University
- Investigators
- Raziye ŞAVKIN, Assoc. Prof., Study chair, Pamukkale UniversityBeyza Hilal TOY, Msc. PT., Principal investigator, Pamukkale UniversityUmmuhan BAŞ ASLAN, Prof., Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244718
- Sponsor's protocol ID
- E-60116787-020-481634
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Music-Assisted Progressive Muscle Relaxation on Sleep Quality, Fatigue, Emotional Symptoms, and Quality of Life in Sedentary Obese Women
- ClinicalTrials.gov ID
- NCT07244718
- Acronym / sponsor ID
- E-60116787-020-481634
- Conditions
- Progressive Muscle Relaxation Technique
- Keywords
- Progressive Muscle Relaxation Technique, Sleep Quality, Mood, Fatique, Quality of Life, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: ControlParticipants 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 |
| Intervention group | Experimental | Other: Music-Assisted Progressive Muscle RelaxationAt 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlNo 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 | Other | Control group |
| Music-Assisted Progressive Muscle RelaxationAt 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 | Other | Intervention group |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Progressive Muscle Relaxation Technique
Not yet recruiting
Influence Of Different Relaxation Techniques On Stress Level For Patients With Bruxism Using Salivary Biomarkers.
Bruxism, Stress (Psychology)
Not yet recruiting
The Effectiveness of Breathing Training in Subacute Neck Pain
Active Cycle of Breathing Technique, Progressive Muscle Relaxation
Not yet recruiting
Effect of Progressive Muscle Relaxation and Diaphragmatic Breathing on Sleep Disturbances in Chemotherapy Patients
Sleep Disturbance, Sleep Disorders
Recruiting
Comparative Effects of Aerobic Exercises and Jacobson's Progressive Relaxation Technique in Primary Dysmenorrhea
Dysmenorrhea
Active, not recruiting
Combined Effect of Benson Relaxation Technique and Jacobson Progressive Muscle Relaxation Exercises on Premenstrual Syndrome
Premenstrual Syndrome-PMS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raziye ŞAVKIN, Assoc. Prof. study chair
Pamukkale University
Beyza Hilal TOY, Msc. PT. principal investigator
Pamukkale University
Ummuhan BAŞ ASLAN, Prof. principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-Assisted Progressive Muscle Relaxation in people with Progressive Muscle Relaxation Technique, run by Pamukkale University 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 9 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pittsburgh Sleep Quality Index (time frame: Baseline (Week 0) and Week 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2025.