| CTRI Number |
CTRI/2020/08/027174 [Registered on: 15/08/2020] Trial Registered Prospectively |
| Last Modified On: |
07/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Psychological Impact of COVID 19 on frontline health care workers |
|
Scientific Title of Study
|
Psychosocial impact and coping strategies of frontline healthcare workers in Western Rajasthan during COVID-19 pandemic |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KAMLESH KUMARI |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9780040150 |
| Fax |
|
| Email |
kamlesh.gmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAMLESH KUMARI |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9780040150 |
| Fax |
|
| Email |
kamlesh.gmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KAMLESH KUMARI |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur
Department of Anaesthesiology and Critical Care, AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9780040150 |
| Fax |
|
| Email |
kamlesh.gmch@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aiims Jodhpur |
| Address |
AIIMS Jodhpur |
| 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 Kamlesh Kumari |
AIIMS Jodhpur |
Department of Anesthesiology and Critical Care, AIIMS JODHPUR
Jodhpur
RAJASTHAN |
9780040150
kamlesh.gmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, AIIMS Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Frontline Health care workers in COVID -19 Pandemic |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All frontline health care workers (Doctors and Nursing Staff) who have done COVID duties wearing PPE KIt |
|
| ExclusionCriteria |
| Details |
Frontline health care workers working in COVID Suspect areas without PPE Kit |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the sources of stress, psychosocial impact and coping strategies amongst frontline HCW working in PPE suit in western Rajasthan during the COVID-19 outbreak |
10 Days after mailing online Google form |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the proportion of various problems |
10 Days after mailing online Google form |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present cross-sectional observational study is planned to know the sources of stress, psychosocial impacts, and coping strategies among frontline health care workers working in personal protective equipment (PPE) kit in western Rajasthan during COVID-19 pandemic |