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CTRI Number  CTRI/2025/04/084173 [Registered on: 04/04/2025] Trial Registered Prospectively
Last Modified On: 04/04/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study to assess the professional competence among undergraduate nursing students. 
Scientific Title of Study   A study to assess the self reported professional competence and factors influencing competence among undergraduate nursing students of selected institutions of Udupi Taluk. 
Trial Acronym  Nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chaithra Prabhu 
Designation  Student 
Affiliation  Manipal College of Nursing  
Address  Room No - 105, First Floor, Manipal College of Nursing MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  8296227247  
Fax    
Email  chaithraprabhu2019@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Melita Sheilini 
Designation  Associate Professor 
Affiliation  Manipal College of Nursing  
Address  Room No.502,Fifth Floor,Department of Medical Surgical Nursing,Manipal College of Nursing MAHE Manipal
Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA
576104
India 
Phone  8095976561  
Fax    
Email  shyli.mel@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Radhika R Pai 
Designation  Assistant Professor-senior scale 
Affiliation  Manipal College of Nursing 
Address  Room No.501,Fifth Floor,Department of Medical Surgical Nursing,Manipal College of Nursing MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  8867785379  
Fax    
Email  radhika.r@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Nursing MAHE Manipal 576104 Udupi District, Karnataka,India 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 Melita Sheilini  Manipal College of Nursing  Room No.502,Fifth Floor,Department of Medical Surgical Nursing,Manipal College of Nursing MAHE Manipal
Udupi
KARNATAKA 
8095976561

shyli.mel@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba 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 Volunteers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  21.00 Year(s)
Gender  Both 
Details  Undergraduate nursing students consenting for participation and available during data collection 
 
ExclusionCriteria 
Details  Under graduate nursing students not available during data collection. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
professional competence and factors influencing professional competence  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   15/04/2025 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   This study is undertaken to assess the self reported professional competency of undergraduate nursing students. It encompasses a range of skills and attributes necessary for effective  nursing practice. It includes core abilities such as patient centered care,communication,evidence based practice, critical thinking,personal traits, quality of practice,collaboration,professional practice evaluation,nursing care management,resource utilization and legal and ethical practice. Understanding students’ self reported competence level helps to recognize domains for rectification to come up with strategies to enhance competence, and thus help in high quality patient care and patient safety. 
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