| CTRI Number |
CTRI/2025/06/089565 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
EFFECTS OF AEROBIC AND RELAXATION IN PRIMARY DYSMENORRHEA |
|
Scientific Title of Study
|
EFFECTS OF AEROBIC EXERCISE AND RELAXATION ON PAIN AND MENSTRUAL DISTRESS IN PRIMARY DYSMENORRHEA-AN EXPERIMENTAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalyani Kulkarni |
| Designation |
PG Student |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth |
| Address |
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University Piparia,Waghodia,Vadodara-391760
Gujarat, India.
Vadodara
GUJARAT
391760
India |
| Phone |
7769097391 |
| Fax |
|
| Email |
kulkarnikalyani0224@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Mukkamala |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth |
| Address |
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University Piparia,Waghodia,Vadodara-391760
Gujarat, India.
Vadodara
GUJARAT
391760
India |
| Phone |
9898216184 |
| Fax |
|
| Email |
neha.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Mukkamala |
| Designation |
Associate Professor |
| Affiliation |
College of Physiotherapy, Sumandeep Vidyapeeth |
| Address |
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University Piparia,Waghodia,Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9898216184 |
| Fax |
|
| Email |
neha.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy electrotherapy lab |
|
|
Primary Sponsor
|
| Name |
Kalyani Kulkarni |
| Address |
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University Piparia,Waghodia,Vadodara-391760
Gujarat, India. |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kalyani Kulkarni |
Dhiraj hospital Sumandeep vidyapeeth piparia waghodia vadodara 391760 gujarat |
Dhiraj hospital Sumandeep Vidyapeeth Deemed to be University Piparia, Waghodia,Vaododara-391760 Gujarat,India
Vadodara
GUJARAT |
7769097391
kulkarnikalyani0224@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Primary Dysmenorrhea |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic exercises |
Aerobic exercises will start with warmup phase than protocol of aerobic exercise will be initiated and cool down phase will be given after aerobic exercise, Duration of intervention is 2 months. |
| Comparator Agent |
Relaxation |
Jacobson relaxation technique will be given during menses,for 2months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1] Adult females diagnosed with primary dysmenorrhea
2] Age of group 18 to 35 years
3] Having regular menstrual cycle
|
|
| ExclusionCriteria |
| Details |
1]Females with any other gynecological conditions such as PCOS.
2]Females with any comorbidities like Hypertension and Diabetes.
3] Females with any musculoskeletal, neurological and cardiovascular disorder.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical pain rating scale |
The outcome measure will be taken 3 times during the study 1st day of menstrual cycle the and post 1month again scale will be taken, post 2 months of aerobic exercises and relaxation 3rd time scale will be taken.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Menstrual distress questionnaire |
The outcome measure will be taken 3 times during the study 1st day of menstrual cycle the females will ask to fill up the questionnaire and post 1month again questionnaire will be taken, post 2 months of aerobic exercises and relaxation 3rd time menstrual distress questionnaire will be taken. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
19/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/07/2025 |
| 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 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 - NO
|
|
Brief Summary
|
76 female will be selected diagnosed as primary dysmenorrhea females will be divided in to 2 groups Group A will be given only aerobic exercises and Group B will be given aerobic exercises and relaxation the protocol will be of 2 months 2 outcome measures will be taken Numerical pain rating scale, Menstrual distress questionnaire will be taken to evaluate the symptoms and pain |