| CTRI Number |
CTRI/2020/02/023422 [Registered on: 18/02/2020] Trial Registered Prospectively |
| Last Modified On: |
17/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
descriptive survey |
| Study Design |
Other |
|
Public Title of Study
|
"A study to assess the self-kindness, self-respect and wellness among elderly in udupi talik, karnataka" |
|
Scientific Title of Study
|
“A study to assess the self-compassion, self-esteem and wellbeing among elderly in selected villages of Udupi taluk, Karnataka†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tsering dolma |
| Designation |
student |
| Affiliation |
Manipal academy of higher education |
| Address |
Second year M.Sc Nursing,
6th floor
Manipal college of Nursing
MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9871328918 |
| Fax |
|
| Email |
tsering412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MrsAsha K Nayak |
| Designation |
Assistant Professor |
| Affiliation |
Manipal academy of Higher education |
| Address |
Department of Mental health Nursing, 6th floor,MCON, MAHE Manipal,Udupi, Karnataka
576104
India
nil
Udupi
KARNATAKA
576104
India |
| Phone |
9448252940 |
| Fax |
|
| Email |
asha.np@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
MrsAnusuya Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Child Health, 2 floor, Nursing, MCON, MAHE Manipal, Udupi, Karnataka
576104
India
Nil
Udupi
KARNATAKA
576104
India |
| Phone |
9901731734 |
| Fax |
|
| Email |
anusuya.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tsering Dolma |
| Address |
Second year Msc Nursing
6th floor,
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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| tsering dolma |
Modubelle, Belle Gramapanchayat |
Manipal college of Nursing, Manipal academy of higher education, Manipal
Udupi
KARNATAKA |
9871328918
tsering412@gmail.com |
|
|
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 |
to assess self-compassion,self-esteem and wellbeing |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Elderly people 60 years and above.
Those who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Elderly with dementia and disorientation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Higher self-compassion increase self-esteem and wellbeing |
1 Time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase the awareness about self-copassion,self-esteem and wellbeing |
1 Time |
|
|
Target Sample Size
|
Total Sample Size="386"
Sample Size from India="386"
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)
|
24/02/2020 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. BACKGROUND OF THE STUDY Self-compassion is ‘‘being open to and moved by one’s own suffering, experiencing feelings of caring and kindness toward oneself, taking an understanding, non-judgmental attitude toward one’s inadequacies and failures, and recognizing that one’s experience is part of the common human experience’’ by Kristine Neff, (Neff, 2003). Self-compassion can be distinguished from self-esteem in that it provides a safe and caring context whereby one can connect with the negative aspects of self (Breines & Chen, 2012) without engaging in suppression or exaggeration of these feelings (Neff, Kirkpatrick, & Rude, 2007).Study showed that self-compassion may protect older individuals who experience negative life events from a decline in well-being. In part, this effect is probably due to the coping strategies that are inherent in the self-compassionate mind-set (Allen & Leary, 2010).
Most of the older adults have moderate level of emotional well-being and they adapt to the cognitive changes and regulate their emotions than suppressing it. Emotion regulation is helpful for older adults which lead to improved well-being. (Fave D. A., 2018). “A study to assess the self-compassion, self-esteem and wellbeing among elderly in selected villages of Udupi taluk, Karnataka†Purpose of the study: • The purpose of the study is to gain insight of self-compassion and to identify its relations on self-esteem and wellbeing. • It will help the health team members and family members to plan health promotion activities that stimulate a change in giving care to the elderly people.
|