| CTRI Number |
CTRI/2021/11/037993 [Registered on: 12/11/2021] Trial Registered Prospectively |
| Last Modified On: |
11/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Stress and coping methods used by undergraduate medical students
|
|
Scientific Title of Study
|
Perceived stress and coping mechanisms among undergraduate medical students |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikram Singh |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine
3rd floor, Pathology Block
2, Bahadur Shah Zafar Marg,
Maulana Azad Medical College, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9953456616 |
| Fax |
|
| Email |
vik2find@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Singh |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine
3rd floor, Pathology Block
Bahadur Shah Zafar Marg,
Maulana Azad Medical College, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9953456616 |
| Fax |
|
| Email |
vik2find@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandini Sharma |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Community Medicine
3rd floor, Pathology Block
Bahadur Shah Zafar Marg,
Maulana Azad Medical College, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9811089659 |
| Fax |
|
| Email |
drnandini1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department of Community Medicine
3rd floor, Pathology Block Bahadur Shah Zafar Marg
Maulana Azad Medical College
New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Vikram Singh |
Maulana Azad Medical College |
Department of Community Medicine
3rd floor, Pathology Block
Bahadur Shah Zafar Marg
Central
DELHI |
9953456616
vik2find@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Medical Students, Stress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Undergraduate students from second year and final year MBBS batches of Maulana Azad Medical College.
|
|
| ExclusionCriteria |
| Details |
Those medical students with pre-existing psychiatric illness diagnosed before getting admission in the medical college.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of Perceived Stress. |
10 days before professional examination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find out factors associated with stress amongst the medical students.
2. Coping mechanism used by the medical students to overcome stress.
|
one year |
|
|
Target Sample Size
|
Total Sample Size="440"
Sample Size from India="440"
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)
|
21/11/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
Study will be carried out among second and final year undergraduate medical students of Maulana Azad Medical College with the aim to determine the perceived stress among the medical students and to assess the various coping mechanisms in response to stress among the students and also to find out factors associated with stress amongst the medical students.
|