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CTRI Number  CTRI/2017/10/009974 [Registered on: 03/10/2017] Trial Registered Prospectively
Last Modified On: 30/09/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Association between Self compassion and Subjective well being 
Scientific Title of Study   Association between Self compassion and Subjective well being among Undergraduate students  
Trial Acronym  ASCSWBUGS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aswathi Lokanath 
Designation  Student 
Affiliation  Manipal University 
Address  Lovely House, Tuneri PO, Nadapuram via, Calicut Kerala

Kozhikode
KERALA
673505
India 
Phone  8289926049  
Fax    
Email  aswathikurup16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepa M Rasquinha 
Designation  Assistant Professor 
Affiliation  Manipal University 
Address  Dept. of Clinical Psychology, Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  9901108729  
Fax    
Email  peterdeepa8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepa M Rasquinha 
Designation  Assistant Professor 
Affiliation  Manipal University 
Address  Dept. of Clinical Psychology, Manipal University Manipal

Udupi
KARNATAKA
576104
India 
Phone  9901108729  
Fax    
Email  peterdeepa8@gmail.com  
 
Source of Monetary or Material Support  
Department of clinical Psychology, Manipal University, Manipal, Karnataka 576104 
 
Primary Sponsor  
Name  Department of clinical Psychology 
Address  Department of clinical Psychology, School of Allied Health Sciences, Manipal University, Manipal, Karnataka, 576104 
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 
Aswathi Lokanath  School of Allied Health Sciences  Department of Clinical Psychology, School of Allied Health Sciences, Manipal University, Manipal, Karnataka, 576104
Udupi
KARNATAKA 
8289926049

aswathikurup16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC& KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants who are visually or physically handicapped are excluded. Also participants who are or has been under psychiatric medication is also excluded which is asked in the data collection form.  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  22.00 Year(s)
Gender  Both 
Details  Students who have currently completed their first year of Undergraduation in SOAHS, Manipal University.  
 
ExclusionCriteria 
Details  Students who study Psychology as their Major Course.
Students who are visually or physically handicapped.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
In Self Compassion Scale,the score range is:
1-2.5 as low
2.5-3.5 as moderate, and
3.5-5.0 as high in self compassion.

In Subjective well being Inventory,the score range is :
40-60 as low
61-80 as Moderate
81-120 as High in Subjective well being.

 
Single point contact Cross sectional study. No PRE/POST testing involved

 
 
Secondary Outcome  
Outcome  TimePoints 
Statistical data regarding Self compassion and Subjective well being among Undergraduate students.  Not Applicable 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   Phase 1 
Date of First Enrollment (India)   03/10/2017 
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="5"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The study is titled "Association between Self compassion and Subjective well being among Undergraduate students". It aims to study the association between Self compassion and  Subjective well being among Undergraduate students of SOAHS, Manipal University. 
The objectives of the study are:

  •          To examine the association between Self compassion and Subjective well being among Undergraduate students.
  •          To examine the association between Self compassion and gender among Undergraduate students.
  •         To examine the association between Subjective well being and gender among Undergraduate students.

The  Hypotheses of the study are :

·         H0: There is no association between Self compassion and Subjective well being among Undergraduate students.

·          H0: There is no association between Self compassion and gender among Undergraduate students.

·          H0: There is no association between Subjective well being and gender among Undergraduate students


 
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