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CTRI Number  CTRI/2024/09/074325 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 16/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Progressive Muscle relaxation]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Progressive Muscle Relaxation Technique on Menopausal symptoms and life quality among Menopausal Women. 
Scientific Title of Study   Effectiveness of Progressive Muscle Relaxation Technique on Menopausal symptoms, Sexual Function, Sleep quality and Overall life quality among Menopausal Women at selected urban communities, Tambaram, Chengalpattu District. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bavanipriya V 
Designation  Associate Professor 
Affiliation  BHAARATH UNIVERSITY 
Address  Department of Community Health Nursing, Bharath Institute of Higher Education and Research BHAARATH UNIVERSITY No. 173, Agaram road, Selaiyur, Chennai - 73
Department of Community Health Nursing, Bharath Institute of Higher Education and Research BHAARATH UNIVERSITY No. 173, Agaram road, Selaiyur, Chennai - 73
Chennai
TAMIL NADU
600073
India 
Phone  9840641765  
Fax    
Email  bavnipriyavijay@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. M. Abirami., 
Designation  Professor 
Affiliation  BHAARATH UNIVERSITY 
Address  Department of Psychiatric Nursing, Bhaarath College of Nursing, Bharath Institute of Higher Education and Research, 173, Agaram road, Selaiyur, Chennai - 73
Department of Psychiatric Nursing, Bhaarath College of Nursing, Bharath Institute of Higher Education and Research, 173, Agaram road, Selaiyur, Chennai - 73
Chennai
TAMIL NADU
600073
India 
Phone  8870653119  
Fax    
Email  abisaisenthil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Manimala  
Designation  Voluntary Health Worker 
Affiliation  NGO 
Address  Community Development NGO for Women, Viswashanthi trust Narasingapuram colony, Singaperumalkoil, Tambaram
Community Development NGO for Women, Viswashanthi trust Narasingapuram colony, Singaperumalkoil, Tambaram
Chennai
TAMIL NADU
600073
India 
Phone  8056193248  
Fax    
Email  manimalasaba@gmail.com  
 
Source of Monetary or Material Support  
Not Applicable  
 
Primary Sponsor  
Name  Bavanipriya V 
Address  Menopausal society, Real Hope Foundation Ganpathipuram Ganapathipuram East Tamabaram Chennai - 600073 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bavanipriya V  Bharath Medical College and Hospitals  Department of Community Medicine, 11th and 12th ward Selaiyur East Tambaram Chennai - 600073
Chennai
TAMIL NADU 		 9840641765

bavanipriyavijay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaarath Medical College and Hospitals, Institution Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Menopausal Women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Active exercises on their own  Participants in the controlled group will be assessed over a 2-month period. Initially, subjects will undergo an assessment to record baseline data on menopausal symptoms, sexual function, sleep quality, and overall life quality. They will then engage in aerobic exercises on their own. Follow-up assessments will be conducted after the 4th week, 6th week, and 8th week to evaluate changes in the recorded parameters. 
Intervention  Progressive Muscle Relaxation Technique. (PMRT)  PMRT for 2 months Progressive Muscle Relaxation teaches you how to relax your muscles through a sixstep process. First, you systematically tense particular muscle groups in your body, such as your neck and shoulders. Next, you release the tension and notice how your muscles feel when you relax them. This exercise will help you to lower your overall tension and stress levels, and help you relax when you are feeling anxious. It can also help reduce physical problems such as stomachaches and headaches, as well as improve your sleep. People with anxiety difficulties are often so tense throughout the day that they don’t even recognize what being relaxed feels like. Through practice you can learn to distinguish between the feelings of a tensed muscle and a completely relaxed muscle. Then, you can begin to “cue” this relaxed state at the first sign of the muscle tension that accompanies your feelings of anxiety. By tensing and releasing, you learn not only what relaxation feels like, but also to recognize when you are starting to get tense during the session.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  Inclusion criteria for the participants includes,
Menopausal women in the age group of 40 – 60 years.
Menopausal women willing to perform exercises.
Menopausal women without contraindications related to performing the physical activity and she might not indulged in any kind of structured physical activities or exercise program since 6 months.
Menopausal women without any medical or surgical intervention.
 
 
ExclusionCriteria 
Details  Exclusion criteria for the participants include Middle-aged women having
Menopause due to any surgical condition like oophorectomy, hysterectomy.
Pathology related to musculoskeletal and cardiovascular system, cognitive impairments and neurological disorders.
Recent Orthopedic surgery of lower back and lower limb.
Hormone replacement therapy.
Gynaecological problems like endometriosis, fibroids, ovarian cysts, prolapsed uterus.
Taking oral anti-depressant medications and
History of vertigo or fall in previous 6 months.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Menopausal symptoms, sexual function, sleep quality and overall life quality  base line, 4th week, 6th week and 8th week  
 
Secondary Outcome  
Outcome  TimePoints 
holistic health care  Menopausal women comprehensive health promotion 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   27/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  27/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included SPSS).

  6. For how long will this data be available start date provided 26-09-2024 and end date provided 26-09-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
A study to evaluate the impact of Progressive Muscle Relaxation on Menopausal symptoms, Sexual function, sleep quality and overall life quality among menopausal women Objective: The study aims to evaluate the effects of Progressive Muscle Relaxation (PMR) on menopausal symptoms, sexual function, sleep quality, and overall life quality in menopausal women. Methodology: Participants: Menopausal women were recruited and randomly assigned to either the PMR group or a control group.  Intervention: The PMR group underwent regular sessions of Progressive Muscle Relaxation, a technique that involves systematically tensing and relaxing different muscle groups to reduce stress and promote relaxation. Assessments: Menopausal Symptoms: Evaluated using a standardized menopausal symptom checklist. Sexual Function: Assessed through questionnaires designed to measure various aspects of sexual health and function. Sleep Quality: Measured using validated sleep quality scales and self-reported sleep diaries. Overall Life Quality: Assessed with comprehensive quality of life questionnaires that cover physical, emotional, and social well-being. Progressive Muscle Relaxation is an effective technique for alleviating menopausal symptoms, enhancing sexual function, improving sleep quality, and boosting overall life quality among menopausal women. Regular practice of PMR can be a valuable non-pharmacological intervention to support women’s health during menopause.

 
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