| CTRI Number |
CTRI/2022/01/039790 [Registered on: 28/01/2022] Trial Registered Prospectively |
| Last Modified On: |
07/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the relationship between Body image, Appearance Contingent Self- Worth, and Self- Compassion among youth |
|
Scientific Title of Study
|
A study to assess the correlation between Body image, Appearance Contingent Self- Worth, and Self- Compassion among youth studying in selected colleges of Udupi, Karnataka |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Preejana Sharma |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
Manipal Academy of Higher Education, Manipal |
| Address |
Manipal College of Nursing, MAHE, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7679971835 |
| Fax |
|
| Email |
preejana.sharma@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Asha K Nayak |
| Designation |
Assistant Professor- Senior Scale |
| Affiliation |
Manipal Academy of Higher Education, Manipal |
| Address |
Manipal College of Nursing, MAHE, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9448252940 |
| Fax |
|
| Email |
asha.np@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Flavia Sharlet Noronha |
| Designation |
Lecturer |
| Affiliation |
Manipal Academy of Higher Education, Manipal |
| Address |
Manipal College of Nursing, MAHE, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9483927967 |
| Fax |
|
| Email |
flavia.noronha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing, MAHE , Manipal |
|
|
Primary Sponsor
|
| Name |
Preejana Sharma |
| Address |
Manipal College of Nursing, MAHE, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suja Karkada |
CSI Lombard college of Nursing |
CSI Lombard college of Nursing Mission Street Udupi
Udupi
KARNATAKA |
08202520384
lmconudupi@gmail.com |
| DrSharath Kumar Rao |
Kasturba Medical College, Manipal |
Kasturba Medical College, Madhavnagar, Manipal, Udupi
Udupi
KARNATAKA |
08202922367
dean.kmc@manipal.edu |
| Dr Judith Angelitta Noronha |
Manipal College of Nursing |
Manipal College of Nursing, MAHE, Manipal
Udupi
KARNATAKA |
08202922443
office.con@manipal.edu |
| Dr Anil Rana |
Manipal Institute of Technology |
Manipal Institute of Technology, MAHE, Manipal
Udupi
KARNATAKA |
08202571060
anil.rana@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No specific health condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Youth between 18-24years age studying for 1st year professional courses such as engineering, medical and nursing of selected colleges of Udupi, Karnataka. |
|
| ExclusionCriteria |
| Details |
Youth who are not ready to take part in the study.
Youth who are having congenital birth defects.
Youth who have any health issues which have affected their body image.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| correlation between Body image, appearance contingent self- worth and self- compassion |
one point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body image, appearance contingent self- worth and self- compassion |
one point |
|
|
Target Sample Size
|
Total Sample Size="480"
Sample Size from India="480"
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)
|
10/02/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is descriptive correlational survey to assess the Body image, Appearance Contingent Self- Worth,
and Self- Compassion among youth studying in selected colleges of Udupi, Karnataka.
It is one point study where the data will be collected using stratified proportionate sampling technique among the 1st year professional college students studying MBBS, Engineering and B.Sc. Nursing. The data will be collected by administering structured questionnaire to the participants. |