| CTRI Number |
CTRI/2020/10/028524 [Registered on: 21/10/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Impact of Covid-19 on mental health among health care workers.
|
|
Scientific Title of Study
|
Impact of Covid-19 on mental health and secondary traumatization among health care workers.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shabnum Thakur |
| Designation |
Senior resident |
| Affiliation |
IGMC Shimla |
| Address |
Room no. 31, 3rd floor, tertiary care cancer center
IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9459830966 |
| Fax |
|
| Email |
thakurshabnum7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shabnum Thakur |
| Designation |
Senior resident |
| Affiliation |
IGMC Shimla |
| Address |
Room no. 31, 3rd floor, tertiary care cancer center
IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9459830966 |
| Fax |
|
| Email |
thakurshabnum7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shabnum Thakur |
| Designation |
Senior resident |
| Affiliation |
IGMC Shimla |
| Address |
Room no. 31, 3rd floor, tertiary care cancer center
IGMC Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9459830966 |
| Fax |
|
| Email |
thakurshabnum7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tertiary Care Cancer Center, IGMC Shimla |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| 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 Shabnum Thakur |
IGMC Shimla |
Room no.: 31,3rd floor, Tertiary care cancer centre
Shimla
HIMACHAL PRADESH |
9459830966
thakurshabnum7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committe IGMC Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Doctors and nurses |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
The health care worker (frontline health worker / back ground health worker) wish to participate and able to further share the survey links in social groups. Participant should know how to use social network groups (what’s-app and email).
|
|
| ExclusionCriteria |
| Details |
The participants fail to submit their survey with in the set time duration of six months (December 2020 to May 2020).
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study the differences in secondary traumas experienced by the frontline workers (doctors and nurses working with COVID-19 patients) and by the background health care professionals( doctors and nurses working with non –COVID-19 patients).
Our results aim to help in the early recognition and remedying of secondary trauma in health care professionals, as well as identifying the important risk factors for future research.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the differences in secondary traumas experienced by the frontline workers (doctors and nurses working with COVID-19 patients) and by the background health care professionals( doctors and nurses working with non –COVID-19 patients).
Our results aim to help in the early recognition and remedying of secondary trauma in health care professionals, as well as identifying the important risk factors for future research.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="632"
Sample Size from India="632"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2020 |
| 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
|
In this COVID era, professionals who work for extended amounts of time with patients with previous traumas are prone to experiencing secondary trauma. It is important to recognise and remedying of secondary trauma in health care professionals, as well as identifying the important risk factors for future research. |