FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/08/027492 [Registered on: 31/08/2020] Trial Registered Prospectively
Last Modified On: 29/08/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Mental health status, adjustment strategies due to covid19 pandemic and related factors  
Scientific Title of Study   Mental health status, coping strategies owing to covid19 pandemic and associated factors among students of healthcare profession 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jayanti MIshra 
Designation  Professor , Hod 
Affiliation  Kalinga Institute of Medical Sciences, KIIT University. 
Address  Department of Physiology, campus-5, KIMS, KIIT University
C5/2, Chandrama Complex, Kharavela Nagar, Bhubaneswar,Odisha, 751001
Khordha
ORISSA
751024
India 
Phone  9438461373  
Fax    
Email  jayanti.mishra@kims.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Jayanti MIshra 
Designation  Professor , Hod 
Affiliation  Kalinga Institute of Medical Sciences, KIIT University. 
Address  Department of Physiology, campus-5, KIMS, KIIT University
C5/2, Chandrama Complex, Kharavela Nagar, Bhubaneswar, Odisha, 751001
Khordha
ORISSA
751024
India 
Phone  9438461373  
Fax    
Email  jayanti.mishra@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  Jayanti MIshra 
Designation  Professor , Hod 
Affiliation  Kalinga Institute of Medical Sciences, KIIT University. 
Address  Department of Physiology, campus-5, KIMS, KIIT University
C5/2, Chandrama Complex, Kharavela Nagar, Bhubaneswar, Odisha, 751001
Khordha
ORISSA
751024
India 
Phone  9438461373  
Fax    
Email  jayanti.mishra@kims.ac.in  
 
Source of Monetary or Material Support  
Kalinga Institute of Medical Sciences, KIIT University, Bhubaneswar, Odisha,751024 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [Cross sectional ] 
 
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 
Prof Dr Jayanti Mishra  Kalinga Institute of Medical Sciences, KIIT University  Research Lab,Department of Physiology, KIMS, KIIT University, Bhubaneswar, 751024
Khordha
ORISSA 		 9438461373

jayanti.mishra@kims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, KIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  GOOD 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  20.00 Year(s)
Gender  Both 
Details  Four hundred first year and second year students of Medical,Dental and Nursing School 
 
ExclusionCriteria 
Details  Those students having Known cardiovascular, respiratory and endocrine abnormalities or any other systemic diseases  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Significant number of subjects may be having a mental status amounting to depression and the coping strategies maynot be appropriate among them.  Twelve Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1.The study may reveal that the covid-19 pandemic has a deleterious effect on the sleeping pattern and eating habits of a significant number of subjects.
2.There may be a positive correlation between the depression scores and sleeping pattern and eating habit scores.
 		 3 months 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
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)   06/09/2020 
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   The COVID 19 pandemic represents a massive impact on human mental health, causing sudden life style changes.Optimizing public health during this pandemic requires not only knowledge from the medical and biological sciences, but also of all human sciences related to life style, social and behavioural  studies, including dietary habits and life style. Objective of study is to assess the mental health status and coping practices adapted by students of health care profession during covid 19 pandemic and socio demographic or psychosocial factors associated with mental health status of the students of health care profession. Sample size : 400, duration 6 months and it is a cross sectional study. Mental status would be assessed from the DASS 21 scale, and PHQ9. Their Coping status would be assessed by the use of brief COPE. Sleep pattern would be assessed by PSQI with google online forms. Significant number of subjects may be having a mental status amounting to depression and coping strategies may not be appropriate among them. The study may reveal that the covid 19 pandemic has a deleterious effect on the sleeping pattern and eating habits of a significant no of subjects. There may be a positive correlation between the depression scores and sleeping pattern and eating habit. 
Close