| CTRI Number |
CTRI/2020/06/025764 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
09/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of depression, anxiety and coping strategies among Health care workers working in dedicated COVID-19 hospitals |
|
Scientific Title of Study
|
Assessment of depression, anxiety and coping strategies among Health care workers working in dedicated COVID-19 hospitals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Niteen Abhivant |
| Designation |
Associate Professor |
| Affiliation |
B.J.Government Medical College, Pune Maharashtra |
| Address |
Department of Psychiatry, B. J. Government Medical College, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
8308806099 |
| Fax |
|
| Email |
abhivantniteen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Niteen Abhivant |
| Designation |
Associate Professor |
| Affiliation |
B.J.Government Medical College, Pune Maharashtra |
| Address |
Department of Psychiatry, B. J. Government Medical College, Pune
B-506, Navkar Residency, Bibvewadi, Pune. 411037
Pune
MAHARASHTRA
411001
India |
| Phone |
8308806099 |
| Fax |
|
| Email |
abhivantniteen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Niteen Abhivant |
| Designation |
Associate Professor |
| Affiliation |
B.J.Government Medical College, Pune Maharashtra |
| Address |
Department of Psychiatry, B. J. Government Medical College, Pune
B-506, Navkar Residency, Bibvewadi, Pune. 411037
Pune
MAHARASHTRA
411001
India |
| Phone |
8308806099 |
| Fax |
|
| Email |
abhivantniteen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Psychiatry, B. J. Government Medical College, Pune |
|
|
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 |
| Niteen Abhivant |
B,J, Government Medical college, Pune |
Department of Psychiatry, B. J. Government Medical College, Pune
Pune
MAHARASHTRA |
8308806099
abhivantniteen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| B. J. Government Medical College and Sassoon General Hospitals, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Depression, Anxiety aand coping mechanisms
|
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Health care workers working at different levels in dedicated COVID-19 Hospital.
2. Healthcare workers of both sexes will be included.
3. Those who are willing to give consent. |
|
| ExclusionCriteria |
| Details |
Those who are having pre-existing Psychiatric illness. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be increased level of depression and anxiety among healthcare workers |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient care will be affected due to increased levels of depression and anxiety among healthcare workers |
3 months |
|
|
Target Sample Size
|
Total Sample Size="93"
Sample Size from India="93"
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)
|
22/06/2020 |
| 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="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
|
In view of current unprecedented situation of COVID-19 pandemic, multiple stressors such as changing work schedules, social isolation, restrictions in daily life and the fear of getting infected is expected to lead to a rise in stress, anxiety and depression in healthcare workers working in dedicated COVID-19 hospitals. This will in turn affect their mental and physical health and lead to a reduction of the quality and efficiency of their work performance. Our proposed study will assess the depression and anxiety in health care workers & will study the various coping mechanisms used by them while working in dedicated COVID-19 hospitals. This will help the hospital administration to address the mental health issues in healthcare workers and prepare for betterment of services rendered by them towards patient care. The study will be conducted on health care workers working in dedicated COVID-19 hospital. After the study protocol gets approval from the Institutional Ethics Committee, information regarding the study will be given to health care workers. Those who fulfill inclusion and exclusion criteria will be included in the study after they give written informed consent for the same.GAD-7 (Generalised Anxiety Disorder-7) & PHQ-9 (Patient Health Questionnaire-9) tools will be used in the study to assess anxiety & depression in the participants respectively. Coping Inventory for Stressful Situations-21 (CISS-21) will be used to study coping measures used by the participants. A Semistructured sociodemographic proforma will be prepared consisting of sociodemographic details and above tools. This proforma will be sent to the participants either online Google form or offline as per their convenience. The results obtained will be tabulated and statistical analysis will be done. |