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CTRI Number  CTRI/2025/11/097218 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 08/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assess the clinical skills and factors affecting clinical skills among final year B.Sc Nursing students studing in selected colleges in Udupi district, Karnataka. 
Scientific Title of Study   An exploratory study to assess the perceived clinical competence and factors affecting clinical competence among final year B.Sc Nursing students in selected colleges of Udupi District,Karnataka. 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
Nill  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ananya Nandy 
Designation  MSC Nursing 2nd year student 
Affiliation  Manipal College Of Nursing 
Address  Room no: 15, Sharada Hostel, Department of Child Health Nursing, Manipal Collge Of Nursing, Manipal Academy Of Higher Education, Madhava Nagar,Manipal,Karnataka State, India.

Udupi
KARNATAKA
576104
India 
Phone  8250243291  
Fax    
Email  nandyananya9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Anjalin D Souza 
Designation  Assistant Professor-Selection Grade, 
Affiliation  Manipal College Of Nursing 
Address  Manipal Collge Of Nursing, Manipal Academy Of Higher Education, Madhava Nagar,Manipal,Karnataka State, India.

Udupi
KARNATAKA
576104
India 
Phone  8250243291  
Fax    
Email  anjeline.d@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ananya Nandy 
Designation  MSC Nursing 2nd year student 
Affiliation  Manipal College Of Nursing 
Address  Room no:15, Sharada hostel, Department of Child Health Nursing,Manipal Collge Of Nursing, Manipal Academy Of Higher Education, Madhava Nagar,Manipal,Karnataka State, India.

Udupi
KARNATAKA
576104
India 
Phone  8250243291  
Fax    
Email  nandyananya9@gmail.com  
 
Source of Monetary or Material Support  
ManipalAcademy of Higher Education. Tiger Circle Road,Madhav Nagar, Manipal, Karnataka 576104 
 
Primary Sponsor  
Name  Ananya Nandy 
Address  Room No-15, ground floor, Manipal College Of Nursing, Madhava Nagar, Manipal, Karnataka State. Pin-576104, India. 
Type of Sponsor  Other [Self] 
 
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 Anjalin D Souza  Manipal College Of Nursing  Madhava Nagar, Manipal, Karnataka State, India, Pin: 576104
Udupi
KARNATAKA 
9845378098

anjeline.d@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-2(student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nursing students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1.4th year B.Sc Nursing students studying in selected nursing college of Udupi district.

2. 4th year B.SC nursing students who will be available during data collection and willing to participate in the study. 
 
ExclusionCriteria 
Details  1. 1ST Year,2nd Year and 3rd year B.Sc nursing students. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. perceived clinical competence   Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Factors affecting clinical competence  Baseline 
 
Target Sample Size   Total Sample Size="309"
Sample Size from India="309" 
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)   28/11/2025 
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   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 will be conducted for final year B.Sc nursing students, studing in selected nursing colleges in Udupi District, Karnataka.
Purpose
The purpose of the study is to assess the level of perceived clinical competence among nursing students.

Objective
1. To assess the perceived clinical competenece among nursing students as measured by clinical competence questionnaire.

2. Explore the factors affecting clinical competence among final year B.Sc Nursing students.

3. Find the association between perceived clinical competence and selected demographic variables.

Methodology
It is a quantative study, data will be collected by sending the goggle form to the participants,.
Three tools or questionnaires were decided for this study
1. Clinical competence questionnaire
2. Rating scale on assessing factors affecting Clinical competence among nursing students.
3. Background proforma.
study design
Explorative survey design.



 
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