| CTRI Number |
CTRI/2020/07/026788 [Registered on: 25/07/2020] Trial Registered Prospectively |
| Last Modified On: |
23/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Qualitative study regarding stress and coping in Front-line Health Care Doctors at a tertiary-care hospital. |
|
Scientific Title of Study
|
A qualitative study of stress and coping in health care workers during COVID 19 pandemic at a tertiary referal hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ivan Stanley Netto |
| Designation |
Associate Professor |
| Affiliation |
B.J.Government Medical College, Pune Maharashtra |
| Address |
Department of Psychiatry,
B.J.Government Medical College,
Pune
Department of Psychiatry,
B.J.Government Medical College,
Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9422081275 |
| Fax |
|
| Email |
drisnetto@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ivan Stanley Netto |
| Designation |
Associate Professor |
| Affiliation |
Indian Psychiatric Society |
| Address |
Department of Psychiatry,
B.J.Government Medical College,
Pune
My personal address is E 10 Parmar Plaza, Shivarkar Road, Fatimanagar, Pune, Maharashtra 411040
Pune
MAHARASHTRA
411001
India |
| Phone |
9422081275 |
| Fax |
|
| Email |
drisnetto@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ivan Stanley Netto |
| Designation |
Associate Professor |
| Affiliation |
B.J.Government Medical College, Pune, Maharashtra |
| Address |
Department of Psychiatry,
B.J.Government Medical College,
Pune
Department of Psychiatry,
B.J.Government Medical College,
Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9422081275 |
| Fax |
|
| Email |
drisnetto@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Psychiatry |
| Address |
Department of Psychiatry,
B.J.Government Medical College,
Pune |
| Type of Sponsor |
Government medical college |
|
|
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 Ivan Stanley Netto |
B.J.,Government Medical College |
Department of Psychiatry,
B.J.,Government Medical College,Pune
Pune
MAHARASHTRA |
9422081275
drisnetto@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| B.J.Government Medical College and Sassoon General Hospital,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress and coping |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthcare workers working in a tertiary referral hospital during Covid 19 pandemic.
2. Healthcare workers both male and female
3. Healthcare workers who are willing to consent for the study. |
|
| ExclusionCriteria |
| Details |
1.Healthcare workers with pre-existing psychiatric disorders. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Due to the Covid Pandemic there will be increased stress among frontline health care workers |
The data will be analysed within the next 6 months by 31 st December 2020 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient care will be affected due to increased stress and difficulties with coping in health care workers. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
17/08/2020 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Paper will be published at the end of study after analysis of results. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Title: A qualitative study of stress and coping in health care workers during the COVID 19 pandemic at a tertiary referral hospital. Introduction:The 2019 coronavirus disease (COVID-19) began as an epidemic in China and now is a global health pandemic, The outbreak was first revealed in late December 2019 when clusters of pneumonia cases of unknown etiology were found to be associated with epidemiologically linked exposure to a seafood market and untraced exposures in the city of Wuhan of Hubei Province. Since then, the number of cases has continued to escalate exponentially within and beyond Wuhan, spreading to all 34 regions of China by 30 January 2020 and now to different countries of the world. The World Health Organization (WHO) declared the COVID-19 outbreak a public health emergency of international concern.Healthcare workers are at the fore front of fighting the Covid – 19 pandemic. Many health care workers have lost their lives in caring for Covid -19 cases. Maintaining health care workers psychological health is essential to better control Covid 10 pandemic, although the best approach remains unclear.This is a qualitative study to assess the stress and coping due to the psychological impact of the COVID-19 outbreak at a tertiary level hospital.This will assist government agencies in safeguarding and planning for the psychological wellbeing of the health care workers in the face of COVID-19 outbreak in the state. Aim & Objectives: A qualitative study of stress and coping in health care workers during the COVID 19 pandemic at a tertiary referral hospital Material & Methods: This is a qualitative study using focus group discussions and in�’depth interviews with health care workers Interview guide: The investigators will use the following probes as the interview guide: • What are the details they elicit as part of the stress & coping in health care workers of Covid -19 cases?• What are the difficulties they experience as part of stress related to Covid-19? • What are the ways in which they resolve these difficulties? After conducting a pilot in�’depth interview, the study recruitment will be initiated. After completing 2–3 interviews, the investigators will code and analyse the transcripts. The investigators will recruit health care workers and coded& analysed transcripts till data saturation will be achieved. As part of availability of participants due to quarantine procedures, the investigators will conduct in-depth interviews & focus groups. The investigators will achieve thematic saturation after completing the analysis of transcripts of all participants and subsequently discontinued data collection. Statistical Analysis: Content analysis was used to identify direct and latent themes Risks involved & Expected Results: No risks involved in the study. The participants will be given online in-depth interviews. |