| CTRI Number |
CTRI/2020/08/027166 [Registered on: 14/08/2020] Trial Registered Prospectively |
| Last Modified On: |
13/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of stress, depression and anxiety in healthcare workers doing COVID duty |
|
Scientific Title of Study
|
Evaluation of stress, depression and anxiety among healthcare workers doing duty for COVID-19 patients in tertiary healthcare facilities |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aatman Parikh |
| Designation |
Psychiatry resident |
| Affiliation |
GCS Medical College Hospital and Research Center |
| Address |
GCS Medical College, Hospital and Research Center, Opp. DRM office, nr. Chamunda Bridge, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
|
| Fax |
|
| Email |
aatmanparikh1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aatman Parikh |
| Designation |
2nd year Psychiatry resident doctor |
| Affiliation |
GCS Medical College Hospital and Research Center |
| Address |
GCS Medical College Hospital and Research Center, Opp. DRM Office, nr. Chamunda bridge, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
9408276620 |
| Fax |
|
| Email |
aatmanparikh1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aatman Parikh |
| Designation |
Psychiatry resident |
| Affiliation |
GCS Medical College Hospital and Research Center |
| Address |
GCS Medical College Hospital and Research Center, Opp. DRM Office, nr. Chamunda bridge, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
|
| Fax |
|
| Email |
aatmanparikh1@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS Medical College Hospital and Research Center |
|
|
Primary Sponsor
|
| Name |
GCS Medical College Hospital and Research Center |
| Address |
GCS Medical College Hospital and Research Center, Opp. DRM Office, nr. Chamunda bridge, Naroda road, Ahmedabad |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| GCS Medical College Hospital and Research Center |
GCS Medical College Hospital and Research Center, Opp. DRM Office, nr. Chamunda bridge, Naroda road, Ahmedabad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aatman Parikh |
GCS Medical College Hospital and Research Center |
Opp. DRM Office, nr. Chamunda bridge, Naroda road, Ahmedabad 380025
Ahmadabad
GUJARAT |
9408276620
aatmanparikh1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee GCS Medical College Hospital and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHCARE WORKERS |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Willing to give consent |
|
| ExclusionCriteria |
| Details |
Not willing to participate/give consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence and severity of depression, anxiety and stress among doctors doing COVID-19 duty
Prevalence and severity of depression, anxiety and stress among para medical staff doing COVID-19 duty |
Baseline day0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of depression, anxiety and stress among doctors and paramedical staff |
Baseline day0 |
|
|
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)
|
18/08/2020 |
| 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="0"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a cross sectional study to evaluate the prevalence and severity of depression, anxiety and stress among doctors and paramedical staff doing COVID-19 duty. The study will help compare the prevalence of depression, anxiety and stress between the two groups of healthcare workers. Various factors like length and place of duty will be correlated. |