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CTRI Number  CTRI/2021/01/030414 [Registered on: 12/01/2021] Trial Registered Prospectively
Last Modified On: 23/11/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Healthcare workers reflections on COVID 19 pandemic 
Scientific Title of Study   Reflections of COVID-19 Health Care Workers: a qualitative 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 Bhalendu Vaishnav 
Designation  Professor and Head 
Affiliation  Pramukhswami Medical College 
Address  Department of Medicine Pramukhswami Medical College, Shree Krishna Hospital Karamsad

Anand
GUJARAT
388325
India 
Phone  9825717481  
Fax    
Email  bhalendusv@charutarhealth.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhalendu Vaishnav 
Designation  Professor and Head 
Affiliation  Pramukhswami Medical College 
Address  Department of Medicine Pramukhswami Medical College, Shree Krishna Hospital Karamsad

Anand
GUJARAT
388325
India 
Phone  9825717481  
Fax    
Email  bhalendusv@charutarhealth.org  
 
Details of Contact Person
Public Query
 
Name  Dr Bhalendu Vaishnav 
Designation  Professor and Head 
Affiliation  Pramukhswami Medical College 
Address  Department of Medicine Pramukhswami Medical College, Shree Krishna Hospital Karamsad

Anand
GUJARAT
388325
India 
Phone  9825717481  
Fax    
Email  bhalendusv@charutarhealth.org  
 
Source of Monetary or Material Support  
Pramukhswami Medical College,Karamsad,Gujarat 
 
Primary Sponsor  
Name  Pramukhswami Medical College 
Address  Department of Medicine Pramukhswami Medical College, Shree Krishna Hospital Karamsad 
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 Bhalendu Vaishnav  Pramukhswami Medical College  Academic auditorium, Department of Medicine Pramukhswami Medical Collegee
Anand
GUJARAT 
9825717481

bhalendusv@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE - 2 H M PATEL CENTRE FOR MEDICAL CARE AND EDUCATION, KARAMSAD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthcare professionals involved in care of COVID19 patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Healthcare workers (residents and faculty members) who have completed at least one posting COVID wards and willing to give consent 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Allow recording and analysis of reflections of healthcare workers engaged in care of COVID patients  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Sensitization and Empowerment of Healthcare workers for handling possible future pandemics  1 year 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   21/01/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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 COVID-19 outbreak has been an unprecedented event which has taken the humanity as a whole and health care services in particular by storm. It has been a challenging time for health care workers who have been caring for patients in the COVID-19 isolation hospitals. Little attention has been given to evaluating the impact of working in pandemic on health care workers’ (HCW) own perspectives in Indian context.

This study is needed to uncover what has been the impact of working in pandemic on health care workers’ perspectives and support needs in various sub-themes such as Physical health, safety and security,Concerns for self,Concerns for others,Practical and environmental issues, Workload etc. Methodology: HCW [Residents / Consultants] who are willing and consenting to participate in the study would be called for a Focus-group discussion. Invitation for participation would be sent by Nodal Officer, COVID hospital (PI). Minimum size for the focus-group would be 8 and maximum not more than 12. We would try to keep equal or almost equal gender distribution. The focus group would be conducted by team members AP and JG. They are suitable for this as both have neither been involved in COVID duty. Session would be audio recorded and transcribed for further analysis.


Ethical issues: Confidentiality will be maintained by undertaking following steps:

1. The transcription would be done by the study team members. The transcriptions would not use individual identity of the study participants. Codes would be assigned to the participants in transcriptions e.g. P1, P2 etc.

2. The analysis would be based on the transcribed content. It would be done by team members (BSV and JV) who will be blind to the identity of the participants.

3. Audio recording would only be in possessions of the AP and JG. And will be kept under password protected folder.

 


 
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