| CTRI Number |
CTRI/2022/08/044834 [Registered on: 23/08/2022] Trial Registered Prospectively |
| Last Modified On: |
17/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Psychological Issues Faced by Healthcare Workers during the COVID-19 Pandemic in a tertiary care hospital |
|
Scientific Title of Study
|
Psychiatric morbidity in health care workers managing COVID-19 patients- A cross sectional study in tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preet Patel |
| Designation |
MD Psychiatry Resident Doctor |
| Affiliation |
GMERS Medical College and Hospital, Gotri |
| Address |
OPD# 204, Department of Psychiatry, GMERS Medical College and Hospital, Gotri
Vadodara
GUJARAT
390021
India |
| Phone |
9601060440 |
| Fax |
|
| Email |
drpatelpreet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha Desai |
| Designation |
Associate Professor in Dept. Of Psychiatry |
| Affiliation |
GMERS Medical College and Hospital, Gotri |
| Address |
OPD No:204, Department of Psychiatry, GMERS Medical College and Hospital, Gotri
Vadodara
GUJARAT
390021
India |
| Phone |
|
| Fax |
|
| Email |
drnimishadesai80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preet Patel |
| Designation |
Psychiatry Resident Doctor |
| Affiliation |
GMERS Medical College and Hospital, Gotri |
| Address |
OPD No:204, Department of Psychiatry, GMERS Medical College and Hospital, Gotri
Vadodara
GUJARAT
390021
India |
| Phone |
|
| Fax |
|
| Email |
drpreetpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| GMERS Medical College and Hospital, Gotri, Vadodara, Gujarat |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Preet Patel |
GMERS Medical college and hospital, Gotri |
Wards and OPD of all departments, Old TB hospital Campus, Gotri Road
Vadodara
GUJARAT |
9601060440
drpatelpreet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human 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 |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Health care workers |
|
| ExclusionCriteria |
| Details |
Health care workers not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the prevalence of depression, anxiety and PTSD among health workers managing COVID-19
patients in a tertiary care hospital. |
9 months, 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the predictors of psychiatric morbidity |
9 months, 1 year |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/09/2022 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
COVID-19 pandemic has been associated with significant occupational stressors and challenges for
front-line healthcare workers (HCWs). This study aims to study the prevalence of depression, anxiety
and PTSD among HCWs and to assess factors contributing to
psychiatric morbidity the during the COVID-19 pandemic in a tertiary care hospital which has been
turned into a COVID dedicated hospital. Findings from this study will help in implementing appropriate plans and policies that will help
to mitigate the distress among health care workers so that we can have efficient frontline
health workers to deal with the current pandemic. |