| CTRI Number |
CTRI/2022/01/039424 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
13/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A survey to assess social, emotional and mental changes in college students post COVID-19
|
|
Scientific Title of Study
|
Psychosocial Adaptability, Emotional Adjustment and Mental Health Status Among College Students in The New Normal Condition: An Exploratory Research
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kathika Chattopadhyay |
| Designation |
Professor HOD Psychiatry Incharge RnD Cell, BHMC&H, Greater Noida |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Room No G 20
Ground Floor
Bakson Homoeopathic Medical College & Hospital
36 B
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9910860193 |
| Fax |
|
| Email |
dr.kathika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kathika Chattopadhyay |
| Designation |
Professor HOD Psychiatry Incharge RnD Cell, BHMC&H, Greater Noida |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Room No G 20
Ground Floor
Bakson Homoeopathic Medical College & Hospital
36 B
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9910860193 |
| Fax |
|
| Email |
dr.kathika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr CP Sharma |
| Designation |
Principal |
| Affiliation |
Bakson Homoeopathic medical college & hospital |
| Address |
Room No G 22
Ground Floor
Bakson Homoeopathic Medical College & Hospital
36 B
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9899101747 |
| Fax |
|
| Email |
principal@bakson.net |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College & Hospital Greater Noida |
|
|
Primary Sponsor
|
| Name |
Bakson Homeopathic Medical College and Hospital Greater Noida |
| Address |
Bakson Homoeopathic Medical College & Hospital
36 B
Knowledge Park 1
Greater Noida |
| Type of Sponsor |
Private 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 Kathika Chattopadhyay |
Bakson Homeopathic Medical college & Hosoital Greater Noida |
Inpatient Department
Room No LG 1 & LG 2
Lower Ground Floor
36 B
Knowledge Park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9910860193
dr.kathika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Bakson Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Survey |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age Group- Above 18 years
Students from Technical College, Non-Technical College and Medical Colleges.
Both Sexes
Subjects willing to consent for the study
|
|
| ExclusionCriteria |
| Details |
All adult subjects having any major medical & neuropsychiatric problem.
All adult subjects having any form of disability
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that in majority of the students, psychosocial adaptability, emotional adjustment and mental health status changed in the new normal conditions
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
20/01/2022 |
| 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="6"
Days="1" |
|
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
|
To assess changes at emotional, mental and adaptability level for college going students post COVID-19. no publication has been published as yet. |