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CTRI Number  CTRI/2021/01/030680 [Registered on: 22/01/2021] Trial Registered Prospectively
Last Modified On: 21/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to find out the stress among the dental students before and during the Covid-19 situation  
Scientific Title of Study   A study to assess the stress among dental students before and during the covid -19 pandemic 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pratik Kumar Bal 
Designation  Post Graduate Student 
Affiliation  Prasanna School of Public Health, MAHE 
Address  Room no. 62, First floor, Prasanna School of Public Health, Mahadev Nagar, Manipal, Karantaka, 576104
Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India 
Phone  08114791602  
Fax    
Email  pratikkumar18101994@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arathi Rao 
Designation  Coordinator, MPH Programme 
Affiliation  Prasanna School Of Public Health 
Address  Room no. 60, First floor, Prasanna School of Public Health, Mahadev Nagar, Manipal, Karantaka, 576104
Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India 
Phone  08202923111  
Fax    
Email  arathi.anil@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Arathi Rao 
Designation  Coordinator, MPH Programme 
Affiliation  Prasanna School Of Public Health 
Address  Room no. 60, First floor, Prasanna School of Public Health, Mahadev Nagar, Manipal, Karantaka, 576104
Udupi Karnataka 576104 India
Udupi
KARNATAKA
576104
India 
Phone  08202923111  
Fax    
Email  arathi.anil@manipal.edu  
 
Source of Monetary or Material Support  
Prasanna School of Public heatlh, MAHE 
 
Primary Sponsor  
Name  Prasanna school of Public Health 
Address  Room no. 63, Prasanna School of Public Health, Mahadev Nagar, Manipal, Karnataka, 576104 
Type of Sponsor  Other [Private Institution of education and research] 
 
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 Atul Anand Bajoria  Kalinga Institute of Dental Sciences  Department of Oral Medicine and Radiology, ground floor, Klainga Institute of Dental Sciences, kiit university, Bhubaeswar, 751024
Khordha
ORISSA 
7978112602

atultink@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Mental and behavioural disorders 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  24.00 Year(s)
Gender  Both 
Details  Students doing internship (dental) at Kalinga Institute of Dental Sciences, Bhubaneswar 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To examine the stress during clinical postings among dental students before and during the ongoing pandemic.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To consider the results and design future interventions for managing stress among the dental students.  6 months - 1 year 
 
Target Sample Size   Total Sample Size="77"
Sample Size from India="77" 
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)   27/01/2021 
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="2"
Days="10" 
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   This is a cross-sectional study to explore the stress level among the dental students before and during the pandemic. The study will be conducted in Kalinga Institute of Dental Sciences, Bhubaneswar on all the interns currently posted in the institute. The primary outcome will be to examine the stress during clinical postings among dental students before and during the ongoing pandemic. The secondary outcome will be to consider these results and design future interventions for managing stress among the dental students. 
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