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CTRI Number  CTRI/2020/12/029743 [Registered on: 11/12/2020] Trial Registered Prospectively
Last Modified On: 10/12/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Analysing effect of COVID 19 on mental health of frontline healthcare workers  
Scientific Title of Study   Impact of COVID 19 on mental health of frontline healthcare workers in India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nandani Gulati 
Designation  Attending Consultant 
Affiliation  Max Smart Super Speciality Hospital 
Address  OPD A2, Department of Pulmonary and Sleep Medicine, Ground Floor, Max Smart Super Speciality Hospital, Press Enclave Marg, Saket

South
DELHI
110017
India 
Phone  9158987170  
Fax    
Email  nandanigulati@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nandani Gulati 
Designation  Attending Consultant 
Affiliation  Max Smart Super Speciality Hospital 
Address  OPD A2, Department of Pulmonary and Sleep Medicine, Ground Floor, Max Smart Super Speciality Hospital, Press Enclave Marg, Saket

South
DELHI
110017
India 
Phone  9158987170  
Fax    
Email  nandanigulati@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nandani Gulati 
Designation  Attending Consultant 
Affiliation  Max Smart Super Speciality Hospital 
Address  OPD A2, Department of Pulmonary and Sleep Medicine, Ground Floor, Max Smart Super Speciality Hospital, Press Enclave Marg, Saket

South
DELHI
110017
India 
Phone  9158987170  
Fax    
Email  nandanigulati@gmail.com  
 
Source of Monetary or Material Support  
Max Smart Super Speciality Hospital Saket 
 
Primary Sponsor  
Name  Max Smart Super Speciality Hospital 
Address  Press Enclave Marg, Saket District Centre, Saket, New Delhi, Delhi 110017 
Type of Sponsor  Private hospital/clinic 
 
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 
Nandani Gulati  Max Smart Super Speciality Hospital  OPD A2, Department of Pulmonary and Sleep Medicine, Ground Floor, Max Smart Super Speciality Hospital, Press Enclave Marg, Saket
South
DELHI 		 9158987170

nandanigulati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Max Healthcare Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy healthcare workers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Healthcare workers (Doctors and Nurses) in hospitals taking care of COVID 19 patients
2. Able and willing to provide informed consent.
 
 
ExclusionCriteria 
Details  Participants who meet any of the following criteria:
Previously diagnosed case of any mental health disorders

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
9-item Patient Health Questionnaire Score
7-item Generalized Anxiety Disorder Score
7-item Insomnia Severity Index
Perceived Stress Scale Score
 		 At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
No Secondary outcome  Not Applicable 
 
Target Sample Size   Total Sample Size="246"
Sample Size from India="246" 
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)   21/12/2020 
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="6"
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  

INTRODUCTION & BACKGROUND

 

The world is in the midst of the COVID19 pandemic (1, 2). Frontline healthcare workers directly involved in the diagnosis, treatment and care of patients with COVID 19 are under the risk of developing various mental health symptoms. Rising number of cases in India, overwhelming workload, use of personal protective equipment for long hours, staying away from family, feeling of being inadequately supported and other factors may contribute to mental health problems in them.

Therefore, the purpose of this study is to estimate the prevalence of stress, anxiety, depression and insomnia in frontline healthcare workers.

 

OBJECTIVES

Primary objectives: To assess the impact of COVID 19 on mental health of frontline health care workers in India

 

Rationale for the study: COVID 19 is a highly contagious coronavirus disease which had gripped the whole world bringing unprecedented challenges to the healthcare system. With rising cases in India, it is presenting overwhelming workloads to healthcare workers and simultaneously affecting the mental well-being. There is limited data available in India on its impact on the mental health of healthcare workers working in this pandemic.

 

ELIGIBILITY CRITERIA

Inclusion Criteria: Participants must satisfy all the following criteria to be included in the study:

1. Male, female >= 18 years of age

2. Healthcare workers (Doctors and Nurses) in hospitals taking care of COVID 19 patients

3. Able and willing to provide informed consent.

Exclusion criteria:

Participants who meet any of the following criteria:

1. Previously diagnosed case of any mental health disorders

 

OUTCOMES

Primary outcomes:

9-item Patient Health Questionnaire Score

7-item Generalized Anxiety Disorder Score

7-item Insomnia Severity Index

Perceived Stress Scale Score

STUDY DESIGN

Multicentric Cross sectional online survey-based study

2 Group Analysis

Test group- frontline healthcare workers

Control group- second line healthcare workers

Frontline healthcare workers defined as physicians and nurses in direct contact and directly involved in taking care of COVID 19 patients

Second line healthcare workers defined as physicians and nurses not in direct contact with COVID 19 patients

 

SAMPLE SIZE

With a margin of error of 0.5 in our estimate on either side, the MINIMUM sample size comes to 246. The formula used for this purpose is as follows:

 

where z = 1.96, L is the margin of error and sigma is the SD.

 

In case dropouts are expected, you may like to begin with a larger sample to get a final sample of at least 246

 

 

 

Statistical Analysis

 

Statistical analysis will be done using SPSS 20 for calculations. Quantitative data (i.e. the scores of four measurement tools) will be presented as mean and SD, median and IQ range in normally distributed data and not normally distributed data respectively.

 

Qualitative data will be expressed as percentages and comparison between two groups will be done using chi square test and fisher’s exact test. Comparison between two groups will be done using student t test and Mann whitney test respectively.

 

A level of 5% will be used for statistical significance.

 
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