| CTRI Number |
CTRI/2020/05/025220 [Registered on: 17/05/2020] Trial Registered Prospectively |
| Last Modified On: |
16/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of COVID-19 pandemic and Psychological Well-being of Healthcare Professionals and Support Staff in Max Super Speciality Hospital, Saket in New Delhi, India. |
|
Scientific Title of Study
|
Impact of COVID-19 Pandemic on Psychological Wellbeing of Healthcare Professionals 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 |
Hiba Siddiqui |
| Designation |
Senior Psycho- Oncologist |
| Affiliation |
Max Super Speciality Hospital,Saket |
| Address |
Max Super Speciality Hospital,A Unit of Devki Devi Foundation,2,Press Enclave Road,Saket
272 Jamia Nagar Teachers College Road,New Delhi
South
DELHI
110017
India |
| Phone |
9911175205 |
| Fax |
|
| Email |
hiba.siddiqui16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hiba Siddiqui |
| Designation |
Senior Psycho- Oncologist |
| Affiliation |
Max Super Speciality Hospital,Saket |
| Address |
Max Super Speciality Hospital,A Unit of Devki Devi Foundation,2,Press Enclave Road,Saket
272 Jamia Nagar Teachers College Road,New Delhi
South
DELHI
110017
India |
| Phone |
9911175205 |
| Fax |
|
| Email |
hiba.siddiqui16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hiba Siddiqui |
| Designation |
Senior Psycho- Oncologist |
| Affiliation |
Max Super Speciality Hospital,Saket |
| Address |
Max Super Speciality Hospital,A Unit of Devki Devi Foundation,2,Press Enclave Road,Saket
272 Jamia Nagar Teachers College Road,New Delhi
South
DELHI
110017
India |
| Phone |
9911175205 |
| Fax |
|
| Email |
hiba.siddiqui16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital(A Unit of Devki Devi foundation),Saket |
|
|
Primary Sponsor
|
| Name |
Hiba Siddiqui |
| Address |
Max Super Speciality Hospital,A Unit of Devki Devi Foundation,2,Press Enclave Road,Saket,New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Hiba Siddiqui |
Max Super Speciality Hospital,(A Unit of Devki Devi Foundation),Saket |
Max Super Speciality Hospital(A Unit of Devki Devi Foundation),2,Press Enclave Road,Saket,New Delhi
South
DELHI |
9911175205
hiba.siddiqui16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Max Super Speciality Hospital(A Unit of Devki Devi Foundation)Saket,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthcare Professionals |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthcare professionals working in Max Super Speciality Hospital,Saket,New Delhi.
2.Healthcare professionals inclusive of doctors,nurses,paramedics,front office employee and support staff.
3.Healthcare professionals above 18years of age.
4.Healthcare professionals residing in India. |
|
| ExclusionCriteria |
| Details |
1.Non-employees of Max Super Speciality Hospital,Saket,New Delhi.
2.Healthcare professionals residing outside India. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Specific to the sub-scale domain assessed, individual psychotherapy sessions would
be provided to the identified healthcare professionals reporting severity of psychological
distress and if the individual is in need of further management or somatic symptom
related treatment, they will be guided for pharmacotherapy. |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Resilience building and planning will be implemented via individual, group and/or
online based training portals to the cohort falling in the range of mild-moderate levels of
psychological distress. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="1300"
Sample Size from India="1300"
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)
|
20/05/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To Study the epidemiology of psychological distress among healthcare professionals of Max Super Speciality Hospital,Saket,New Delhi in India during the COVID-19 Pandemic and assess the implications for providing psychological interventions(or Therapeutic services) |