| CTRI Number |
CTRI/2020/07/026865 [Registered on: 28/07/2020] Trial Registered Prospectively |
| Last Modified On: |
21/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Aerobic Exercise] |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
THis study is to check the positive outcome of the aerobic exercise on the students who have pain during periods or menstruation. |
|
Scientific Title of Study
|
Effect of aerobic exercise on dysmenorrhoea among adolescent girls |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ibadapbiang Shisha Dkhar |
| Designation |
M.Sc Nursing Student |
| Affiliation |
College of Nursing,Jawaharlal Institute of Post Graduate Medical Education and Research. Pondicherry |
| Address |
Nightingale House Room no 318, Jawaharlal Institute of Post Graduate Medical Education and Research.(JIPMER) Pondicherry
605006 India
Nightingale House Room no 318, Jawaharlal Institute of Post Graduate Medical Education and Research.(JIPMER) Pondicherry
605006 India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8724836348 |
| Fax |
0413-2272066 |
| Email |
doldkhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Vahitha S |
| Designation |
Lecturer, Obstetrics & Gynaecological Nursing |
| Affiliation |
College of Nursing,Jawaharlal Institute of Post Graduate Medical Education and Research. Pondicherry |
| Address |
College of Nursing,Jawaharlal Institute of Post Graduate Medical Education and Research. Pondicherry
College of Nursing,Jawaharlal Institute of Post Graduate Medical Education and Research. Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9840924805 |
| Fax |
0413-2272066 |
| Email |
vahiarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ibadapbiang Shisha Dkhar |
| Designation |
M.Sc Nursing Student, OBG Nursing |
| Affiliation |
College of Nursing,Jawaharlal Institute of Post Graduate Medical Education and Research. Pondicherry |
| Address |
Nightingale House Room no 318, Jawaharlal Institute of Post Graduate Medical Education and Research. Pondicherry
605006 India
Nightingale House Room no 318, Jawaharlal Institute of Post Graduate Medical Education and Research. Pondicherry
605006 India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8724836348 |
| Fax |
0413-2272066 |
| Email |
doldkhar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ibadapbiang Shisha Dkhar |
| Address |
Nightingale House Room no 318, Jawaharlal Institute of Post Graduate Medical Education and Research. Pondicherry
605006 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ibadapbiang Shisha Dkhar |
JIPMER,Puducherry |
College of Nursing,JIPMER Puducherry and MOther Theresa Post Graduate & REsearch Institute of Health Sciences, College of Nursing Puducherry.
Pondicherry
PONDICHERRY |
8724836348
0413-2272066
doldkhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human Studies)JIPMER Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adolescent Girls with Dysmenorrhoea. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AErobic Exercise |
In group 1 Aerobic exercise will be given for 40-45 minutes once in a day daily with pre-test and post test assessment to the students. |
| Intervention |
Aerobic Exercise |
In group 2 no intervention will be given only pretest post test assessment will be done. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
Adolescent girls who are having pain during menstruation |
|
| ExclusionCriteria |
| Details |
Adolescent girls who have other gynaecological problems. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will suggest that Aerobic exercise will reduce the pain during menstruation |
45minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aerobic exercise will be effective for reducing dysmenorrhoea |
3 menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
01/08/2020 |
| 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="0"
Months="3"
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
|
This study is a Cluster randomization trial which will compare the effectiveness of Aerobic Exercise between adolescent girls who are having dysmenorrhoea with intervention and the other group of adolescent girls who will not be getting any intervention. The total sample size is 144 where each group will have 72 sample. Adolesent girls who are 18-19years are included in this study and other girls who are having other gynaecological problems will be excluded from the study. The study will be done in two settings in Collge of Nursing ,JIPMER Puducherry and Mother Theresa Post Graduate & Research Institute of Health Sciences, College of Nursing. |