| 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 |
|
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Details of Secondary Sponsor
|
|
|
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
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
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Intervention / Comparator Agent
|
|
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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 |
|
|
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. |