| CTRI Number |
CTRI/2019/10/021719 [Registered on: 18/10/2019] Trial Registered Prospectively |
| Last Modified On: |
18/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of yoga on menstrual pain among deaf and dumb adolescent girls in a residential school - A randomized controlled trial |
|
Scientific Title of Study
|
Effect of yoga on dysmenorrhoea among hearing and speech impaired adolescent girls in a residential school - A randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepika Vishwanath |
| Designation |
Post graduate student |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
KLEU Institute of Physiotherapy, J.N. Medical Campus, Nehru Nagar.
Belgaum
KARNATAKA
590010
India |
| Phone |
8884883943 |
| Fax |
|
| Email |
vdeepika00987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Metgud |
| Designation |
Professor |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
KLEU Institute of Physiotherapy, J.N. Medical Campus, Nehru Nagar.
Belgaum
KARNATAKA
590010
India |
| Phone |
8884883943 |
| Fax |
|
| Email |
vdeepu2695@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika Vishwanath |
| Designation |
Post graduate student |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
KLEU Institute of Physiotherapy, J.N. Medical Campus, Nehru Nagar.
Belgaum
KARNATAKA
590010
India |
| Phone |
8884883943 |
| Fax |
|
| Email |
vdeepika00987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government school for deaf and dumb, Azam Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
Deepika Vishwanath |
| Address |
Plot No 40, Shivbasav Nagar, Belagavi |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Deepika |
Government school for deaf children |
Government school, 1st cross, Bauxite Road, Azam Nagar
Belgaum
KARNATAKA |
8884883943
vdeepika00987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hearing and Speech Impaired adolescent girls |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention. |
Participants are allowed to follow the regular management for pain. |
| Intervention |
Yoga |
12 weeks of Yoga practice with three times in a week. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Female |
| Details |
All menstruating adolescent girls with regular menses since 1 year. |
|
| ExclusionCriteria |
| Details |
Participants diagnosed with pelvic pathology.
Participants with irregular menstrual cycle
Participants with any medication related to menstruation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
MOOS Distress Questionnaire
Numerical Pain Rating Scale |
Baseline, 4 weeks, 8 weeks and 12 weeks. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/10/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose: To determine the effect of yoga on primary dysmenorrhea among hearing and speech impaired adolescent girls in a residential school using Numerical Pain Rating Scale (NPRS) and Moos Distress questionnaire
| Hypothesis: | H0 : There may not be any effect of yoga on dysmenorrhea among hearing and speech impaired adolescent girls in a residential school. | H1: There may be an effect of yoga on dysmenorrhea among hearing and speech impaired adolescent girls in a residential school | |