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CTRI Number  CTRI/2020/07/026798 [Registered on: 25/07/2020] Trial Registered Prospectively
Last Modified On: 24/07/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Depression, Anxiety and Stress among healthcare workers during the curved 19 pandemic 
Scientific Title of Study   Prevalence and Correlates of Depression,Anxiety and Stress among health care workers 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  Dr Ridhima Sharma 
Designation  Assistant professor 
Affiliation  Super Speciality Paediatric Hospital and Post Graduate Teaching Institute 
Address  Department of Paediatric anaesthesia Second floor Room no 3 Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida sec 30
Department of Paediatric anaesthesia Second floor Room no 3 Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida sec 30
Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  08054549458  
Fax    
Email  drridhimasharma@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ridhima Sharma 
Designation  Assistant professor 
Affiliation  Super Speciality Paediatric Hospital and Post Graduate Teaching Institute 
Address  Department of Paediatric anaesthesia Second floor Room no 3 Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida sec 30
Department of Paediatric anaesthesia Second floor Room no 3 Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida sec 30
Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  08054549458  
Fax    
Email  drridhimasharma@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ridhima Sharma 
Designation  Assistant professor 
Affiliation  Super Speciality Paediatric Hospital and Post Graduate Teaching Institute 
Address  Department of Paediatric anaesthesia Second floor Room no 3 Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida sec 30
Department of Paediatric anaesthesia Second floor Room no 3 Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida sec 30
Gautam Buddha Nagar
UTTAR PRADESH
201307
India 
Phone  08054549458  
Fax    
Email  drridhimasharma@yahoo.com  
 
Source of Monetary or Material Support  
Dr Ridhima Sharma Assistant Professor Department of Paediatric anaesthesia Second floor Room no 3 Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida sec 30 
 
Primary Sponsor  
Name  DrRidhima Sharma 
Address  Department of Paediatric anaesthesia Second floor Room no 3 Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida sec 30 
Type of Sponsor  Other [Self] 
 
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 Ridhima Sharma  Super Speciality Paediatric hospital and postgraduate teaching institute  Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida sec 30
Gautam Buddha Nagar
UTTAR PRADESH 		 08054549458

drridhimasharma@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Superspeciality Paediatric hospital and post graduate teaching institute Ethice committe CDSCO registration ECR1320Ins/UP2019  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  All the healthy health care workers HCW working in our COVID care center 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The outbreak of the COVID-19 virus pandemic has taxed an unrivalled psychological stress substantially affecting the medical health care workers. However, there is a definitive lack of an evidence-based assessment and mental health attributes in the front-line health workers. To notify this gap, the current study was performed to evaluate the prevalence of depression, stress and anxiety among the health care workers and its correlation with various factors.
Methods: The current cross-sectional study was conducted in 200 HCW in our tertiary care center. The primary outcomes were to compare the prevalence of depression, anxiety and stress among the health care workers. Thereafter we used multivariate regression to determine the factors correlated to either depression, anxiety or stress. The secondary outcome was to compare DASS (depression, anxiety, stress) between the first line worker and the second line worker and other commonly associated factors responsible for increased DASS-21 scores.
 
 
ExclusionCriteria 
Details  Healthcare workers who were not willing to participate or already have clinically diagnosed depression anxiety or any other mental illness were excluded from the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Primary outcome were to compare the prevalence of depression, anxiety and stress among the health care workers and administrative staff. Thereafter we used multivariate regression to determine the factors correlated to either depression, anxiety or stress.
The secondary outcome was to compare DAS between the first line worker and the second line worker and multiple factors attributing to increased DAS were noted.
 		 1 week
 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome was to compare DAS between the first line worker and the second line worker and multiple factors attributing to increased DAS were noted.

 		 1 week 
 
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)   03/08/2020 
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="5" 
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   The outbreak of the COVID-19 virus pandemic has taxed an unrivaled psychological stress substantially affecting the medical health care workers. However, there’s a definitive lack of an evidence- based assessment and mental health attributes in the front-line health workers. To notify this gap,the current study was performed to evaluate the prevalence of depression, stress and anxiety among the HCWs and its correlation with various factors. 
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