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CTRI Number  CTRI/2021/04/032802 [Registered on: 13/04/2021] Trial Registered Prospectively
Last Modified On: 26/11/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship between emotional maturity and perceived stress regarding life among nursing students  
Scientific Title of Study   Relationship between emotional maturity and perceived stress regarding life among nursing students in selected nursing colleges of Mangaluru 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preeval Josna Saldanha 
Designation  4th year B.Sc Nursing Student 
Affiliation  Laxmi Memorial College of Nursing  
Address  Laxmi Memorial College of Nursing, A.J. Towers, Balmatta, Mangalore-575002, Dakshina Kannada, Karnataka
Laxmi Memorial College of Nursing, A.J. Towers, Balmatta, Mangalore-575002, Dakshina Kannada, Karnataka
Dakshina Kannada
KARNATAKA
575002
India 
Phone  9980968782  
Fax    
Email  josnasaldanha2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Preeval Josna Saldanha 
Designation  4th year B.Sc Nursing Student 
Affiliation  Laxmi Memorial College of Nursing  
Address  Laxmi Memorial College of Nursing, A.J. Towers, Balmatta, Mangalore-575002, Dakshina Kannada, Karnataka
Laxmi Memorial College of Nursing, A.J. Towers, Balmatta, Mangalore-575002, Dakshina Kannada, Karnataka
Dakshina Kannada
KARNATAKA
575002
India 
Phone  9980968782  
Fax    
Email  josnasaldanha2@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Patsey Sera Castelino 
Designation  Assistant Professor  
Affiliation  Laxmi Memorial College of Nursing 
Address  Laxmi Memorial College of Nursing, A.J. Towers, Balmatta, Mangalore-575002, Dakshina Kannada, Karnataka

Dakshina Kannada
KARNATAKA
575002
India 
Phone  7204546246  
Fax    
Email  pcastelino44@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi University of Health Sciences 
 
Primary Sponsor  
Name  Rajiv Gandhi University of Health Sciences 
Address  4th T Block, Jayanagar, Bengaluru-560 041 
Type of Sponsor  Other [Health Sciences University] 
 
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 Larissa Martha Sams  Laxmi Memorial College of Nursing  A.J. Towers, Balmatta, Mangalore 575002 Department of Research, 2nd floor, Room no. 10
Dakshina Kannada
KARNATAKA 
9945303531

vasini71@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee A.J. Institute of Medical Sciences & Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Relationship between emotional maturity and perceived stress regarding life 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1st year B.Sc nursing students; both male and female
In the age group of 17-35 years
Willing to participate in the research study 
 
ExclusionCriteria 
Details  Nursing students who are not willing to participate
Nursing students who are not present at the time of data collection 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To find the relationship between emotional maturity and perceived stress regarding of nursing students as measured by Emotional Maturity Scale and Perceived Stress Scale   at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To find the association of emotional maturity and perceived stress of nursing students with selected demographic variables  at baseline 
 
Target Sample Size   Total Sample Size="205"
Sample Size from India="205" 
Final Enrollment numbers achieved (Total)= "205"
Final Enrollment numbers achieved (India)="205" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/04/2021 
Date of Study Completion (India) 26/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
The research study is published in Journal of Clinical and Diagnostic Research, 2021 Nov, Vol-15(11): 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
A descriptive correlational research design will be used to identify the relationship between emotional maturity and perceived stress regarding life of nursing students. Emotional maturity and perceived stress will be assessed by administering Emotional Maturity Scale and Perceived Stress Scale developed by Dr. Yashwir Singh and Dr. Mahesh Bhargava and Cohen respectively. 
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