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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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  
Outcome  TimePoints 
NA  NA 
 
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. 

 
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