| CTRI Number |
CTRI/2010/091/000658 [Registered on: 12/07/2010] |
| Last Modified On: |
13/05/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
A clinical trial to study the effects of exercise and hot water bottle in the management of menstrual pain among school girls. |
Scientific Title of Study
Modification(s)
|
A randomized controlled trial of exercise and hot water bottle in the treatment of primary dysmenorrhoea in school girls of Chandigarh,India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrAditi Chaudhuri |
| Designation |
|
| Affiliation |
PGIMER Chandigarh |
| Address |
78c, Binoba Bhave Road,P.O.Sahapur.
junior resident, department of community medicine, postgraduate institute of medical education & research. chandigarh, sector-12. INDIA.
Kolkata
WEST BENGAL
700038
India |
| Phone |
09216224575 |
| Fax |
|
| Email |
draditipgi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Aditi Chaudhuri |
| Designation |
|
| Affiliation |
|
| Address |
78c, Binoba Bhave Road,P.O.Sahapur.
Kolkata
WEST BENGAL
700038
India |
| Phone |
09216224575 |
| Fax |
|
| Email |
draditipgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Aditi Chaudhuri |
| Designation |
|
| Affiliation |
|
| Address |
78c, Binoba Bhave Road,P.O.Sahapur.
Kolkata
WEST BENGAL
700038
India |
| Phone |
09216224575 |
| Fax |
|
| Email |
draditipgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| postgraduate institute of medical education & research.chandigarh, sector -12.pincode-160012. |
|
|
Primary Sponsor
|
| Name |
dr.aditi chaudhuri. |
| Address |
|
| Type of Sponsor |
|
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr.aditi chaudhuri |
government model high school, sector -12, chandigarh. |
government model senior secondary school, sector -10, chandigarh.,-160012
Chandigarh
CHANDIGARH |
09216224575
draditipgi@gmail.com |
| dr.aditi chaudhuri |
government model senior secondary school, sector-10, chandigarh. |
,-
Chandigarh
CHANDIGARH |
draditipgi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| postgraduate institute of medical education & research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
primary dysmenorrhoea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
exercise |
10-15 minutes each time, twice a day during the whole month, except on the days of menstruation |
| Comparator Agent |
hot water bottle |
to be used for 15-20minutes each time, for 2-3 times a day, during menstrual pain. |
|
|
Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
all school girls of standard 8th to 10th who complains of primary dysmenorrhoea. |
|
| ExclusionCriteria |
| Details |
1. whose parents have not given consent.
2. who are physically handicapped.
3. who are suffering from any condition in which exercise is contraindicated- respiratory disease, heart disease,recent surgery.
4.those with severe dysmenorrhoea and on any medical treatment.
5. those who are not willing to answer the questions or practise the interventions. |
|
Method of Generating Random Sequence
Modification(s)
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| change in pain score |
at 1st, 2nd, 3rd month after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in MENSTRUAL DISTRESS QUESTIONNAIRE score. |
at 1st, 2nd, 3rd month after intervention.
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
19/04/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this study is a randomized, parallel group, active control trial comparing the effect of exercise and hot water bottle in the treatment of primary dysmenorrhoea among school girls of 2 schools in Chandigarh.The primary outcome measures will be change in the intensity of pain and severity of menstrual symptoms after 1st , 2nd, 3rd month after interventions. |