CTRI Number |
CTRI/2020/06/026188 [Registered on: 26/06/2020] Trial Registered Prospectively |
Last Modified On: |
26/06/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Psychological Assessment of adult COVID-19 patients |
Scientific Title of Study
|
Assessment of psychological health of patients diagnosed with COVID-19 |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Jayaprakash Russell Ravan |
Designation |
Associate Professor and Unit Head |
Affiliation |
Kalinga Institute of Medical sciences, KIIT University |
Address |
Department of Psychiatry
Kalinga Institute of Medical Sciences
Basement of Hospital building
Room no 003
KIIT university Bhubaneswar Odisha
Khordha ORISSA 751024 India |
Phone |
8763213999 |
Fax |
|
Email |
jayaprakashrussell.ravan@kims.ac.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Jayaprakash Russell Ravan |
Designation |
Associate Professor and Unit Head |
Affiliation |
Kalinga Institute of Medical sciences, KIIT University |
Address |
Department of Psychiatry
Kalinga Institute of Medical Sciences
Basement of Hospital building
Room no 003
KIIT university Bhubaneswar Odisha
Khordha ORISSA 751024 India |
Phone |
8763213999 |
Fax |
|
Email |
jayaprakashrussell.ravan@kims.ac.in |
|
Details of Contact Person Public Query
|
Name |
Dr Jayaprakash Russell Ravan |
Designation |
Associate Professor and Unit Head |
Affiliation |
Kalinga Institute of Medical sciences, KIIT University |
Address |
Department of Psychiatry
Kalinga Institute of Medical Sciences
Basement of Hospital building Room no 003
KIIT university Bhubaneswar Odisha
Khordha ORISSA 751024 India |
Phone |
8763213999 |
Fax |
|
Email |
jayaprakashrussell.ravan@kims.ac.in |
|
Source of Monetary or Material Support
|
Dean and Principal Kalinga Institute of Medical Sciences
Patia Bhubaneswar PIN 751024 Orissa |
|
Primary Sponsor
|
Name |
KIMS KIIT University |
Address |
Bhubaneswar
patia
751024 |
Type of Sponsor |
Private 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 Jayaprakash Russell Ravan |
Kalinga Institute of Medical Sciences |
Departrment of Psychiatry
KIIT Deemed to be University Bhubaneswar 751024 Khordha ORISSA |
8763213999
jayaprakashrussell.ravan@kims.ac.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics committee, Kalinga institute of medical sciences, KIIT university |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Those willing to give consent |
|
ExclusionCriteria |
Details |
Children
Those under ventilatory support
Those not willing to give consent |
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
Assessment of psychological health : prevalence of depression, anxiety and PTSD symptoms in COVID 19 adult patients in Odisha COVID hospital |
3 months |
|
Secondary Outcome
|
|
Target Sample Size
|
Total Sample Size="240" Sample Size from India="240"
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)
|
06/07/2020 |
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
|
Rationale of the study: Psychological Disturbances among Survivors at the individual level, many people can experience a crisis, defined as a situation caused by an external life event that exceeds a person’s emotional response capacity. Essentially, that person’s coping skills may be insufficient, and a psychological imbalance or failure to adapt occurs. Certain feelings and reactions are common in very emotionally significant situations, such suffering from a serious disease like COVID-19. Moreover, the memory of what happened will be part of the patient’ lives and may never be erased from their memories. However, while some psychological manifestations are the understandable and transitory response to living through traumatic experiences, they can also be indicators that the person is developing a pathological condition. The most common immediate psychological disturbances among survivors are depression and acute, transitory stress reactions and PTSD like symptoms (Peters, C.J, 2002) The main purpose of this study is to measure the prevalence and severity of this psychological distress and therefore provide a concrete basis for tailoring and implementing relevant mental health intervention policies to cope with this challenge efficiently and effectively. |