| CTRI Number |
CTRI/2020/09/028085 [Registered on: 28/09/2020] Trial Registered Prospectively |
| Last Modified On: |
25/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Coping methods of stress among frontline Healthcare workers
|
|
Scientific Title of Study
|
Coping Strategies among Healthcare Providers directly involved in covid-19 care: A 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 |
Dr Yudhyavir Brahmachari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room 5011, %th floor
Teaching Block
AIIMS , Ansari Nagar East
Room NO. 312, third floor
Jai Prakash Narayan Apex Trauma Centre
New delhi
New Delhi
DELHI
110029
India |
| Phone |
9811140057 |
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yudhyavir Brahmachari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room 5011, %th floor
Teaching Block
AIIMS , Ansari Nagar East
Room NO. 312, third floor
Jai Prakash Narayan Apex Trauma Centre
New delhi
DELHI
110029
India |
| Phone |
9811140057 |
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yudhyavir Brahmachari |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
Room 5011, %th floor
Teaching Block
AIIMS , Ansari Nagar East
Room NO. 312, third floor
Jai Prakash Narayan Apex Trauma Centre
New delhi
DELHI
110029
India |
| Phone |
9811140057 |
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jai Prakash Narayan Apex Trauma Centre, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
no sponser |
| Address |
no sponser |
| Type of Sponsor |
Other [no sponser] |
|
|
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 Ridhima Bhatia |
Jai Prakash Narayan Apex Trauma Centre, New Delhi |
Room No. 322
Department of Anesthesiology, Pain Medicine and Critical Care
New Delhi
DELHI |
9876933393
dr.rids90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Depression?anxiety/Mental illness screening in frontline healthcare workers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Healthcare workers involved in direct care of patients with covid 19 disease.
2) Age >18 years and <60 years
3) No h/o prior psychiatric illness
|
|
| ExclusionCriteria |
| Details |
1) Healthcare workers not involved in direct care of patients with covid 19 disease.
2) H/o prior psychiatric illness
|
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
The primary objective is to identify Frontline healthcare workers having difficulty coping with stress related to Covid 19
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objective is to evaluate difference in coping mechanism in
different age group healthcare workers
healthcare workers with different educational level
relation to gender
healthcare workers looking after critically ill patients versus stable patients
|
baseline |
|
|
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)
|
05/10/2020 |
| 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
|
|
The extreme pressures experienced by
healthcare workers during a pandemic may not only increase their risk of
burnout, but also, have adverse outcomes for individual wellbeing, patient
care and the healthcare system. Hence, it is necessary to evaluate the
ability of healthcare workers to cope with the stress.
Till date, there are no studies to evaluate coping
strategies being used by frontline healthcare workers. “Coping†is defined broadly as an effort used to minimize
distress associated with negative life experiences.
Psychological assistance services, including
telephone-, internet and application-based counselling or intervention, have
been widely deployed by local and national mental health institutions in
response to the COVID-19 outbreak. However, evidence-based evaluations and
mental health interventions targeting front-line health care workers are
relatively scarce. So we plan to do this study involving healthcare workers working in covid designated areas and involved in direct care of patients with covid 19 disease
|
|