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CTRI Number  CTRI/2024/02/062706 [Registered on: 15/02/2024] Trial Registered Prospectively
Last Modified On: 09/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assess the Academic stress, Academic performance, and Satisfaction among undergraduate nursing students following the semester system  
Scientific Title of Study   “A Cross-sectional study to assess the Academic stress, Academic performance, and Satisfaction among undergraduate nursing students following the semester system in selected Nursing Colleges in Udupi District, Karnataka. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kalyani Sinha 
Designation  MSC Nursing 2nd year student 
Affiliation   
Address  Manipal
Manipal
Udupi
KARNATAKA
576104
India 
Phone  08895193070  
Fax    
Email  kalyanisinha98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSangeetha p 
Designation  Assistant Professor selection grade.  
Affiliation  Manipal 
Address  Manipal College of Nursing MAHE Manipal. Department of pediatric nursing
Manipal College of Nursing MAHE Manipal. Department of pediatric nursing
Udupi
KARNATAKA
576104
India 
Phone  9844896929  
Fax    
Email  sangeetha.p@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  DrBaby SNayak 
Designation  HOD of Child Health Nursing 
Affiliation  Mnaipal 
Address  Manipal College Of Nursing MAHE Manipal. Department of pediatric Nursing.
Manipal College of Nursing MAHE Manipal. Department of Pediatric Nursing.
Udupi
KARNATAKA
576104
India 
Phone  9632217067  
Fax    
Email  baby.s@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education.Tiger Circle Road ,Madhav Nagar ,Manipal ,Karnataka 576104 
 
Primary Sponsor  
Name  Kalyani Sinha 
Address  Room No-201,2nd floor ,Manipal College of Nursing ,Manipal Academy of Higher Education 
Type of Sponsor  Private medical 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 
Kalyani Sinha  Manipal College of Nursing MAHE Manipal.  Manipal College of Nursing MAHE Manipal.
Udupi
KARNATAKA 
08895193070

kalyanisinha98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Student 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  23.00 Year(s)
Gender  Both 
Details  •Undergraduate nursing students of 2nd and 3rd,4th and 5th semesters studying in selected nursing colleges of Udupi district, Karnataka.
•Undergraduate students who will be available during data collection.
 
 
ExclusionCriteria 
Details  •Students that are unwilling to take part in this research 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Research variables-
Academic Performance, Academic Stress, and Satisfaction
Demographic variables-
Age, gender, health problem.
 
1st December 2023- 31st May2024
6months. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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)   22/02/2024 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study aims to assess the academic stress, academic performance, and academic satisfaction among undergraduate nursing students following the semester system. The findings from the study will give baseline information and help the administrator to plan and incorporate strategies to overcome academic stress and improve academic performance among students.

 
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