| CTRI Number |
CTRI/2024/04/065387 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
01/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study female athletes awareness, experience and views about menstruation and its relation with physical, mental and sports performance |
|
Scientific Title of Study
|
Knowledge, attitude, and Perception of Female Athletes Towards Menstruation on physical, psychological and sports performance indices |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sajal Sharma |
| Designation |
Physiotherapist |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Room No QS 10, Q Block Physiotherapy Department MRIIRS Aravalli Campus,
Sector – 43, Delhi–Suraj Kund
Road
Faridabad
HARYANA
121004
India |
| Phone |
9877638924 |
| Fax |
|
| Email |
sharmasajal450@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasmine Kaur Chawla |
| Designation |
Associate Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
QS 06 Q Block Department Of physiotherapy MRIIRS Aravalli Campus, Sector – 43, Delhi–Suraj Kund
Road
Faridabad
HARYANA
121004
India |
| Phone |
9888263685 |
| Fax |
|
| Email |
Jasminekaur.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasmine Kaur Chawla |
| Designation |
Associate Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
QS 06 Q Block Department of Physiotherapy MRIIRS Aravalli Campus, Sector – 43, Delhi–Suraj Kund
Road
Faridabad
HARYANA
121004
India |
| Phone |
9888263685 |
| Fax |
|
| Email |
Jasminekaur.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International institute of Research and Sciences,Faridabad- 121004, India |
|
|
Primary Sponsor
|
| Name |
Dr Jasmine Kaur Chawla |
| Address |
MRIIRS Aravalli Campus,
Sector – 43, Delhi–Suraj Kund
Road |
| 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 |
| Dr Jasmine Kaur Chawla |
Manav Rachna outpatient department |
QG 09 Deparment of Physiotherapy Manav Rachna University aravalli hills sector -43 Delhi -suraj kund
Faridabad
HARYANA |
9888263685
Jasminekaur.sahs@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Manav Rachna International Institute of Research and Studies, Faridabad, Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menarche |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Those who give consent for the study.
Should be able to understand & comprehend English and Hindi language.
|
|
| ExclusionCriteria |
| Details |
Athletes who diagnosed with any psychiatric condition who have previously had one, or who have declined to participate. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge, attitude and preception towards menstruation score |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="275"
Sample Size from India="275"
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)
|
20/04/2024 |
| 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="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Participants will be included on the based on inclusion and exclusion criteria. Subject will be informed prior about the study and to read and signed an informed consent form. A self structured questionnaire will be developed. Validity and reliability will be done. Demographics data will be obtained and self constructed questionnaire twill be distributed to the participants to be filled on pen /paper mode . Filled questionnaire will be collected. The questionnaire will divided into 3 domains: Knowledge domain Attitude domain Perception domain |