| CTRI Number |
CTRI/2024/03/064378 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Mental Health Issues and stress-coping abilities among athletes |
|
Scientific Title of Study
|
Mental Health Issues and Stress Coping abilities among Indian athletes |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chetan Sharma |
| Designation |
Psychiatric Social Worker |
| Affiliation |
PGIMS |
| Address |
Institute of Mental Health. Department of Psychiatry, Room no.8 PGIMS
Rohtak
HARYANA
124001
India |
| Phone |
9896625379 |
| Fax |
|
| Email |
sharmachetan204@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bhupendra Singh |
| Designation |
Associate Professor |
| Affiliation |
Institute of Mental Health, Pt. B. D.Sharma PGIMSRohtak |
| Address |
Institute of Mental Health
Department of Psychiatry, Room no.8. PGIMS
Rohtak
HARYANA
124001
India |
| Phone |
|
| Fax |
|
| Email |
33bhupendrasingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chetan Sharma |
| Designation |
Psychiatric Social Worker |
| Affiliation |
Tulasi Healthcare, Gurugram |
| Address |
Institute of Mental Health Department of Psychiatry, Room no. 8, PGIMS
Rohtak
HARYANA
124001
India |
| Phone |
9896625379 |
| Fax |
|
| Email |
sharmachetan204@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chetan Sharma |
| Address |
Room no. 11 Institute of Mental Health, PGIMS Rohtak |
| Type of Sponsor |
Other [Self-Funded] |
|
|
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 Bhupendra Singh |
Institute of Mental Health |
Institute of Mental Health Department of Psychiatry, Room no.8 PGIMS
Rohtak
HARYANA |
9896625379
33bhupendrasingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B.D. Sharma UHS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Indian Athletes
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
- Athletes who are currently playing at the Inter-district, Inter-state and international.
- Either female or male gender of athletes.
- Athletes who can understand the Hindi Language. |
|
| ExclusionCriteria |
| Details |
- Athletes with any diagnosed physical illness.
- Athletes with mental illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Level of stress coping abilities and mental health issues
|
From last few weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
26/03/2024 |
| 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) |
Closed to Recruitment of Participants |
|
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
|
We are going to conduct a cross-sectional study to assess the mental health issues and stress-coping abilities of athletes and we have constructed a tool to assess the stress-coping abilities of Athletes. This study will also help develop a standardized tool per Indian perspective. |