| CTRI Number |
CTRI/2025/07/090722 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Exercises on Pain and Discomfort During Periods in adult female students |
|
Scientific Title of Study
|
Effectiveness of Core Stabilization and Breathing Exercise
on Pain and Menstrual Distress in Adult Female Students 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 |
Ms Jarin Tasnim |
| Designation |
Undergraduate Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801304587778 |
| Fax |
|
| Email |
jarintasnim.sat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmila Jahan |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no: 306, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801717362485 |
| Fax |
|
| Email |
Sh.jahan@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila Jahan |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no: 306, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801717362485 |
| Fax |
|
| Email |
Sh.jahan@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore , 7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Dr Ehsanur Rahman |
| Address |
Room no: 401, Department of Physiotherapy and Rehabilitation,
Jashore University of Science and Technology |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Kabir Hossain |
Dr. M R Khan Medical Center |
Level-3, Room: 301, Musculoskeletal Lab, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore, 7408, Bangladesh
|
8801778 315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of Physiotherapy and Rehabilitation, JUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N944||Primary dysmenorrhea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core Stabilization and Breathing exercise |
Core Stabilization exercise: abdominal drawing in maneuver, pelvic tilt, bird dog, front plank, dead bug, bridge;(3 set, 10 repetition; 3 session per week, 30-40 minute per session).
Breathing exercise: Deep breathing, slow placed breathing; (3 set, 10 repetition; 5 session per week, 10-15 minute per session).
Home advice: Use hot water bag during menstruation.
|
| Comparator Agent |
Usual traditional care (No active intervention) |
They will not receive specific intervention but will continue their usual traditional management practice, such as using a hot water bag or taking rest during menstruation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Regular menstrual cycle( 21- 35) days.
Diagnosed with primary dysmenorrhea.
Pain score at VAS scale more than 3.
Those who are not married.
Those who agree to avoid taking any pain relieving medication for menstrual discomfort throughout the study duration.
Willingness to participate.
|
|
| ExclusionCriteria |
| Details |
Secondary Dysmenorrhea
Pelvic surgery.
Hormonal therapy.
Physically active (those who engaged in regular physical exercise)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain is measured by VAS scale.
Menstrual Distress measured using MEDI-Q questionnaire
|
Baseline at 1-2 days after completion of current menstruation.
Post intervention: just before onset of the next menstruation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sleep quality measured by using Pittsburgh sleep quality index.
|
Baseline at 1-2 days after completion of current menstruation.
Post intervention: just before onset of the next menstruation.
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Sh.jahan@just.edu.bd].
- For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the effectiveness of core stabilization and breathing exercises on reducing pain and menstrual distress among adult female students with primary dysmenorrhea. Eligible participants will be randomly assigned to either an intervention group receiving core and breathing exercises, or a control group following their usual self-care practices. The study will measure pain intensity, menstrual distress, and sleep quality using validated tools such as VAS, MEDI-Q, and PSQI. The trial will be conducted at Jashore University of Science and Technology, with recruitment starting on 15 July 2025 |