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CTRI Number  CTRI/2023/03/050173 [Registered on: 01/03/2023] Trial Registered Prospectively
Last Modified On: 28/02/2023
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 the academic stress, perceived parental pressure and anxiety and general wellbeing of adolescents studying in selected Pre-University Colleges of Udupi District, Karnataka. 
Scientific Title of Study   A study to assess the academic stress, perceived parental pressure and anxiety related to competitive entrance examination and the general wellbeing among adolescents in selected Pre-University Colleges of Udupi District, Karnataka. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khriebeizonuo Pienyu 
Designation  Post Graduate Student 
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal 
Address  Department of Child Health Nursing, Second Floor, Manipal College of Nursing, Manipal Academy Of Higher Education, Manipal, Karnataka, India-576104

Udupi
KARNATAKA
576104
India 
Phone  8258052925  
Fax    
Email  felicitapienyuooo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr E Binu Margaret 
Designation  Assistant Professor- Selection Grade  
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal 
Address  Department of Child Health Nursing, Second Floor, Manipal College of Nursing, Manipal Academy Of Higher Education, Manipal, Karnataka, India-576104

Udupi
KARNATAKA
576104
India 
Phone  9844602532  
Fax    
Email  binu.m@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr E Binu Margaret 
Designation  Assistant Professor- Selection Grade  
Affiliation  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal 
Address  Department of Child Health Nursing, Second Floor, Manipal College of Nursing, Manipal Academy Of Higher Education, Manipal, Karnataka, India-576104

Udupi
KARNATAKA
576104
India 
Phone  9844602532  
Fax    
Email  binu.m@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Nursing, Manipal Acdemy of Higher Education, Manipal, Karnataka 
 
Primary Sponsor  
Name  Manipal College of Nursing, Manipal Acamedy of Higher Education, Manipal  
Address  Department of Child Health Nursing, Second Floor, Manipal College of Nursing, Manipal Academy Of Higher Education, Manipal, Karnataka, India-576104  
Type of Sponsor  Other [Private Nursing 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 
Khriebeizonuo Pienyu  Manipal College of Nursing, Manipal Academy of Higher Education, Manipal  Department of Child Health Nursing, Second Floor, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal,Udupi District, Karnataka India - 576104
Udupi
KARNATAKA 
8258052925

felicitapienyuooo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institution Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adolescents who are studying in Pre-University and planning to give competitive entrance examination 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  21.00 Year(s)
Gender  Both 
Details  Students from 11thand 12th standard studying in selected English Medium Pre-University Colleges of Udupi District, Karnataka
Students who are planning to appear for competitive entrance examination.
Students who are willing to participate in the research study.
Student who will be present at the time of data collection
 
 
ExclusionCriteria 
Details  Student who are not willing to participate in the research study and who are not planning to give competetive entrance examination. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Academic Stress, Perceived parental pressure, Anxiety   1 year 
 
Secondary Outcome  
Outcome  TimePoints 
General wellbeing  1 year 
 
Target Sample Size   Total Sample Size="570"
Sample Size from India="570" 
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)   06/03/2023 
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="1"
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)?  

Response - NO
Brief Summary   This study is a cross-sectional survey design to assess the academic stress, perceived parental pressure, anxiety related to competitve entrance examination and the general-wellbeing among adolescents in selected Pre-University colleges of Udupi District, Karnataka. The study also aims to find the relationship between academmic stress, perceived parental pressure, anxiety and general well-being related to competitve entrance examination. The finding of the study will give the baseline information and help in identifying adolescents at risk for mental health concerns and referring them to health care facility, to be better able to reduce the consequences related to it in future. 
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