| CTRI Number |
CTRI/2024/07/070245 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physiotherapy and Yoga] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effects of Core Stability Exercises and Yoga Asanas in Managing Primary Dysmenorrhea |
|
Scientific Title of Study
|
The Effects of Core Stability Exercises and Yoga Asanas in Managing Primary Dysmenorrhea Among College Students:A Quasi 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 |
Nayana Sathyan |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar, Mangalore, Dakahina Kannada, Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7593992286 |
| Fax |
|
| Email |
nayanasathyann@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Radhika Gopal S |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar, Mangalore, Dakahina Kannada, Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7593992286 |
| Fax |
|
| Email |
radhikaradhu1590@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nayana Sathyan |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Department of Physiotherapy, Institute of Physiotherapy, Srinivas University, Pandeshwar, Mangalore, Dakahina Kannada, Karnataka
KARNATAKA
575001
India |
| Phone |
7593992286 |
| Fax |
|
| Email |
nayanasathyann@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,
Institute of Physiotherapy,
Srinivas University, Pandeshwar, Mangalore, Karnataka, 575001 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Department of Physiotherapy,
Institute of Physiotherapy, Srinivas University, Pandeshwar, Dakshina Kannada, Karnataka |
| Type of Sponsor |
Research institution |
|
|
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 |
| Nayana Sathyan |
Institute of Physiotherapy, Srinivas University |
Department of Physiotherapy,
Institute of Physiotherapy,
Srinivas University,
Pandeshwar, Mangalore
Dakshina Kannada
KARNATAKA |
7593992286
nayanasathyann@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Physiotherapy, Srinivas University |
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 |
| Comparator Agent |
Core stability exercises |
Core stability exercises (Pelvic bridging, cat and camel) for eight weeks, four days a week, with each session lasting 20 minutes. |
| Intervention |
Yoga asanas |
Yoga asanas (Bidalasana, Setu bandhasana) for eight weeks, four days a week, with each session lasting 10-15 minutes. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
1. Students who are diagnosed with Primary dysmenorrhea
2. Age between 16 years and 25 years
3. Pain intensity ≥ 6 on NPRS
4. Screened with WaLIDD score
5. Sedentary lifestyle |
|
| ExclusionCriteria |
| Details |
1. Diagnosed with PCOS, Endometriosis, Pelvic inflammatory diseases
2. Subjects with H/O low back pain not related to dysmenorrhea
3. Any previous gynaecological surgeries
4. Performing yoga asanas
5. On NSAIDs for pain relief during or before menstruation |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
WaLIDD Score
|
Baseline, 1 month, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="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 - NO
|
|
Brief Summary
|
The study aims to compare the impact of core stability exercises and yoga poses on primary dysmenorrhea (PD) among college students. After obtaining ethical approval, participants will be screened and asked for informed consent before undergoing assessments. Group A will perform core stability exercises such as cat and camel exercise and pelvic bridging for 20 minutes, four days a week, over eight weeks. Group B will practice yoga poses like Bidalasana and Setu Bandhasana for 10-15 minutes, also four days a week, during the late menstrual cycle phase (days 15-25). Initial assessments will occur during the first four weeks after menstruation, with secondary assessments after two menstrual cycles to evaluate and compare the effectiveness of both interventions on PD symptoms. |