| CTRI Number |
CTRI/2020/10/028257 [Registered on: 06/10/2020] Trial Registered Prospectively |
| Last Modified On: |
01/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Psychological Impacts Of The COVID-19 Pandemic On Medical Students In India: A Web-Based Cross-Sectional Study |
|
Scientific Title of Study
|
The Psychological Impact Of The COVID-19 Pandemic On Medical Students In India: A Web-Based Cross-Sectional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ria Tyagi |
| Designation |
UG Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
D-148 Saket
New DElhi-110017
South
DELHI
110017
India |
| Phone |
9560489361 |
| Fax |
|
| Email |
m0116075@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Natarajan |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department Of Psychiatry, Room Number-11, Sri Ramachandra Institute Of Higher Education And Research
Porur Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9843730810 |
| Fax |
|
| Email |
natarajans@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Natarajan |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department Of Psychiatry,
Room Number-11
Sri Ramachandra Institute Of Higher Education And Research
Porur Chennai 600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9843730810 |
| Fax |
|
| Email |
natarajans@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 |
| Ria Tyagi |
Sri Ramachandra Institute Of Higher Education and Research |
Department Of Psychiatry , Room number-11
Sri Ramachandra Institute Of Higher Education and Research
Porur, Chennai-600116
Chennai
TAMIL NADU |
9560489361
m0116075@sriramachandra.edu.in |
|
|
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 |
Nil |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants aged 18 years and above.
2.Participants will be recruited from regions
afflicted by the COVID-19 pandemic.
3.Participants willing to participate in the
study.
4.Participants with the ability to read, write and understand English language.
|
|
| ExclusionCriteria |
| Details |
1.Participants who are less than 18 years
of age
2.Participants who suffer from a known primary
psychiatric disorder.
3.Participants from regions not affected by with the COVID-19 pandemic.
4.Participants who are unwilling to participate
in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Life Orientation Test- Revised and K-10 Scales and Questionnaire Scores |
Baseline values |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
N/A |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
10/10/2020 |
| 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="1"
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
|
There is an urgent need to address the mental health issues of medical students during this pandemic. Separation from family, the disruption of teaching and the transition from conventional teaching methods to online methods may lead to increased screen time and may place additional strain on the mental well-being of students. This can also lead to decreased mobility of the students resulting in laziness. All of these factors can contribute to frustration, boredom, low mood and even depression in some cases. It is hence essential to underscore the importance of conducting a study such as ours in the medical student community that is already known to have a demanding lifestyle, in order to understand these psychological effects more thoroughly during these immensely challenging and uncertain times. This study therefore aims to provide insights regarding the impact of COVID-19 on medical students’ well-being and to provide an opportunity to address their concerns. |