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CTRI Number  CTRI/2020/05/025347 [Registered on: 25/05/2020] Trial Registered Prospectively
Last Modified On: 25/05/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Psychological impact of COVID-19 pandemic on health care workers 
Scientific Title of Study   Weathering the storm: Psychological impact of COVID-19 pandemic on clinical and non-clinical health care workers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Margiben Tusharbhai Bhatt 
Designation  Senior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Critical care medicine, Kasturba medical college and hospitals, Madhavnagar, Manipal, Karnataka, India.

Udupi
KARNATAKA
576104
India 
Phone  8980025142  
Fax    
Email  margi.bhatt@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunil R 
Designation  Assistant professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Critical care medicine, Kasturba medical college and hospitals, Madhavnagar, Manipal, Karnataka, India.

Udupi
KARNATAKA
576104
India 
Phone  8095800142  
Fax    
Email  sunil.r@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Margiben Tusharbhai Bhatt 
Designation  Senior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Critical care medicine, Kasturba medical college and hospitals, Madhavnagar, Manipal, Karnataka, India.

Udupi
KARNATAKA
576104
India 
Phone  8980025142  
Fax    
Email  margi.bhatt@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospitals, Manipal Academy of higher education, Madhavnagar, Manipal-576104, Karnataka, India 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Department of Critical Care Medicine, Kasturba Medical College, Manipal, Karnataka 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Margiben Tusharbhai Bhatt  Kasturba Medical College  Department of Critical Care medicine,ICU1/2 complex, 1st floor, casaulty and trauma block,Kasturba Medical College, Madhavnagar, Manipal-576104
Udupi
KARNATAKA 		 8980025142

margi.bhatt@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH institutional ethics committee, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Psychological status- insomnia,stress, anxiety, depression 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Clinical and non-clinical Health care workers aged > 21 years 
 
ExclusionCriteria 
Details  Healthcare workers with pre-existing psychiatric illness, Healthcare workers not consenting for the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the psychological impact in terms of insomnia, depression, anxiety, and stress experienced by the health care workers in India.  outcomes will be assessed only at baseline, at a given point of time 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the prevalence of insomnia, depression, anxiety and stress between clinical health care workers and non-clinical health care workers.
To look for the measures to cope up with the added mental burden 		 outcomes will be assessed only at baseline, at a given point of time 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   01/06/2020 
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="4"
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)?  

Brief Summary  

COVID-19 pandemic has spread across the globe creating a significant health crisis. Healthcare workers across the globe are under tremendous pressure in dealing with this pandemic. Mental well-being of health care workers is as important as their physical well-being in this crisis. It is crucial to assess psychological impact of COVID-19 pandemic on the health care workers working as a frontline warrior. This study aims to provide an assessment of mental health burden among Indian health care workers in terms of magnitude of insomnia, depression, anxiety and stress. Understanding of this impact can serve as an important evidence to create awareness about the mental wellbeing among health care workers.

 
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