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CTRI Number  CTRI/2025/10/095656 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 03/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Pelvic Floor Exercises to Reduce Period Pain and Improve Daily Life in Young Women 
Scientific Title of Study   Long term effects of pelvic floor exercise training on pain intensity and quality of life in females with primary dysmenorrhea 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shikha Vyas  
Designation  Post Graduate  
Affiliation  Parul Institute of Physiotherapy 
Address  406, Parul Institute of Physiotherapy, Physiotherapy Department, Parul university campus, Waghodia

Vadodara
GUJARAT
391760
India 
Phone  7433833978  
Fax    
Email  vyasshikha2701@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jahanvi Dave  
Designation  Assistant Professor  
Affiliation  Parul Institute of Physiotherapy 
Address  Parul Institute of Physiotherapy, Department of physiotherapy Parul university campus, Post Limda, Waghodia, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9998028702  
Fax    
Email  jahanvi.dave41102@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Jahanvi Dave  
Designation  Assistant Professor  
Affiliation  Parul Institute of Physiotherapy 
Address  Parul Institute of Physiotherapy, Parul university, Post Limda, Waghodia, Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9998028702  
Fax    
Email  jahanvi.dave41102@paruluniversity.ac.in  
 
Source of Monetary or Material Support  
Parul Institute of Physiotherapy, Parul University 
 
Primary Sponsor  
Name  Shikha Vyas  
Address  Parul Institute of Physiotherapy, Parul University,Post Limda, Waghodia, Gujarat  
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 
Shikha Vyas   Parul University Campus, parul university, Post Limda, Waghodia  Parul Institute of physiotherapy, department of physiotherapy
Vadodara
GUJARAT 		 7433833978

jahanvi.dave41102@paruluniversity.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Parul University Institutional Ethics Committee for Human Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Females with primary dysmenorrhea 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General Mobility Exercises   1. Diaphragmatic breathing (10 Reptations for 3 times a week; Progression of 5 reptations every week) 2. Shoulder girdle movements (10 Reptations for 3 times a week; Progression of 5 reptations every week) 3. Pelvic girdle movements (10 Reptations for 3 times a week; Progression of 5 reptations every week) 4. Lower limb movements (10 Reptations for 3 times a week; Progression of 5 reptations every week) 
Intervention  Pelvic Floor Exercises   1. Hold and relax (10 Reptations for 3 times a week; Progression of 5 reptations every week) 2. Quick Contractions(10 Reptations for 3 times a week; Progression of 5 reptations every week) 3. Elevator exercise (10 Reptations for 3 times a week; Progression of 5 reptations every week) 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1. Subjects with age of 19-25 years
2. Subjects who had menarche at or after 12 years of age
3. Subjects who are experiencing pain while menstruation on day 0 (before periods starts) and day 1
4. Subjects having pain intensity equal to or greater than 5 on VAS Scale
5. Subjects having regular 3 cycles before the study (25-30 days/cycle)
6. Subjects having regular menstruation phase (5-8 days)
7. Subjects who are sexually not active
8. Subjects who are ready to participate
 
 
ExclusionCriteria 
Details  1. Subjects who are undergoing any medications for pain relief or any oral contraceptives
2. Subjects with clinically diagnosed with PCOS, PCOD, etc.
3. Subjects having any history of recent surgery or any trauma
4. Subjects having abnormal vaginal bleeding
5. Subjects presented a psychiatric condition or cognitive deficit
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality Of Life: Menstrual Distress Questionnaire
 		 1. at baseline
2. at 6 weeks
3. at 12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Pain Scale: Visual Analogue Scale   1. at baseline
2. at 6 weeks
3. at 12 weeks  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   N/A 
Date of First Enrollment (India)   15/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Anyone

  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 - Proposals should be directed to [vyasshikha2701@gmail.com].

  6. For how long will this data be available start date provided 15-03-2026 and end date provided 15-03-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The menstrual cycle is a regular, process that occurs in the female reproductive system that makes pregnancy possible. Menstrual pain is one of the most common gynecological complaints defined as a cyclic pain that occurs in association with menstruation. The menstrual disturbances as health problems among young girls affect not only reproductive, but also physical health and quality of life. This pain is said to be dysmenorrhea. It is a widespread condition that affects a significant number of women, especially those in their reproductive years. The pain is typically characterized by cramping in the lower abdomen and pelvis during menstruation, which can vary from mild to severe. The impact of primary dysmenorrhea goes beyond just the physical discomfort; it significantly influences various aspects of a woman’s life like quality of life, productivity at work, use of health care services. So the study mainly focuses on the level of pain and the quality of life for which the pelvic floor exercise training is been compared with traditional form of exercises. The study will see its effect after the exercise session is completed. Pelvic floor exercises can help reduce menstrual pain and discomfort in the short term as well as long term relief.  This study is needed to know how long the effects last and how often the exercises should be done for best results.

 
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