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CTRI Number  CTRI/2019/08/020933 [Registered on: 27/08/2019] Trial Registered Prospectively
Last Modified On: 27/08/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to assess academic stress among class 11 and 12 students in coastal area of Karnataka 
Scientific Title of Study   Academic Stress, Depression and Anxiety among Grade 11 and 12 Learners of Coastal Karnataka: A Cross Sectional Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreemathi S Mayya 
Designation  Professor 
Affiliation  Prasanna School of Public Health 
Address  Dept. of Statistics, Prasanna School of Public Health
Manipal Academy of Higher Education, Manipal-576104
Udupi
KARNATAKA
576104
India 
Phone  09964584055  
Fax    
Email  shreemathi.mayya@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Deepa Marina Rasquinha  
Designation  Assistant Professor 
Affiliation  Manipal College of Health Professionals 
Address  Dept. of Clinical Psychology, Manipal College of Health Professionals
Manipal Academy of Higher Education, Manipal-576104
Udupi
KARNATAKA
576104
India 
Phone  9980057079  
Fax    
Email  deepa.rasquinha@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Shreemathi S Mayya 
Designation  Professor 
Affiliation  Prasanna School of Public Health 
Address  Dept. of Statistics, Prasanna School of Public Health
Manipal Academy of Higher Education, Manipal-576104
Udupi
KARNATAKA
576104
India 
Phone  09964584055  
Fax    
Email  shreemathi.mayya@manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Social Science Research 
 
Primary Sponsor  
Name  Indian Council of Social Science Research 
Address  Ministry of Human Resource Development, JNU Institutional Area, Aruna Asaf Ali Marg, New Delhi-110067 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shreemathi S Mayya  Higher secondary schools  Udupi District
Udupi
KARNATAKA 
09964584055

shreemathi.mayya@manipal.edu 
Shreemathi S Mayya  Higher secondary schools  Uttara Kannada District
Udupi
KARNATAKA 
09964584055

shreemathi.mayya@manipal.edu 
Shreemathi S Mayya  Higher secondary schools  Dakshina Kannada District
Dakshina Kannada
KARNATAKA 
09964584055

shreemathi.mayya@manipal.edu 
 
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  NIL 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  20.00 Year(s)
Gender  Both 
Details  Students of Grade 11 and Grade 12, Studying in Coastal Karnataka 
 
ExclusionCriteria 
Details  None 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Stress, Anxiety and depression Scores
 
Single time point for students of Higher secondary school on the day of visit for the survey from September 1, 2019 to May 1, 2021 
 
Secondary Outcome  
Outcome  TimePoints 
Factors associated stress Anxiety and depression (Demographic and Academic)  At the time of survey in the higher secondary schools from September 1, 2019 to May 1, 2021 
 
Target Sample Size   Total Sample Size="2400"
Sample Size from India="2400" 
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)   02/09/2019 
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="2"
Months="0"
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  

This cross-sectional study will be undertaken among students of grade 11 and 12 of Higher Secondary Schools situated in Costal Karnataka. The Coastal Karnataka comprises three districts, namely Dakshina Kannada, Udupi and Uttara Kannada. From each district ten colleges (5 Government and 5 Private) providing 11th and 12th grade education to science as well as commerce stream will be selected to collect the required data. The rating scale to assess academic stress, depression and anxiety will be administered to classes of science and commerce with a minimum of 20 students, which leads to a minimum of 2400 participants. A tool to assess the Academic Stress, Depression and anxiety developed by the project team, Depression, Anxiety and Stress Scale (DASS) and Perceived Stress Scale (PSS) (10 items) will be used to collect the data. The study is approved by the institutional ethical committee.Consent will be obtained from parents before participating in the study.  Consent/assent will be taken from students.  The questionnaires will be completed during school hours. It will be administered to participants in the respective institution by a trained research assistant after obtaining permission from administrative heads of schools. Participation will be voluntary, and confidentiality of data will be assured. The anonymity of the students, as well as the institution, will be maintained. The data will be analyzed using SPSS version 15. Data will be summarized with appropriate descriptive and inferential statistics.

 
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