| CTRI Number |
CTRI/2024/04/065227 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Qualitative Study exploring well being of adult Indian population who practice community tele-yoga. |
|
Scientific Title of Study
|
A Qualitative Study exploring community tele-yoga practice in adult Indian population: intra & interpersonal relationship, quality of life and adherence. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandini M K |
| Designation |
Post Graduate Student |
| Affiliation |
National Institute of Mental Health and Neuroscience. |
| Address |
New Yoga Centre Building, 3rd floor, Room no.2, Department of
Integrative Medicine, NIMHANS, Bangalore, Karnataka, India.
Bangalore
KARNATAKA
560029
India
Bangalore
KARNATAKA
560029
India |
| Phone |
9663937361 |
| Fax |
|
| Email |
nandinimk73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Bhargav |
| Designation |
Associate Professor of Yoga |
| Affiliation |
National Institute of Mental Health and Neuroscience. |
| Address |
First floor, Department of Integrative Medicine, NIMHANS,
Bangalore, Karnataka, India. Bangalore, Karnataka 560029, India.
Bangalore
KARNATAKA
560029
India
Bangalore
KARNATAKA
560029
India |
| Phone |
8762019348 |
| Fax |
|
| Email |
yogaforstress.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishita Jasti |
| Designation |
Scientist-B |
| Affiliation |
National Institute of Mental Health and Neuroscience. |
| Address |
First floor, Department of Integrative Medicine, NIMHANS,
Bangalore, Karnataka, India. Bangalore, Karnataka 560029, India.
Bangalore
KARNATAKA
560029
India
Bangalore
KARNATAKA
560029
India |
| Phone |
8762150803 |
| Fax |
|
| Email |
nishitha.jasti910@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Integrative Medicine, Yoga centre, NIMHANS, Bangalore, Karnataka 560027. |
|
|
Primary Sponsor
|
| Name |
Dr Nandini M K |
| Address |
3rd Floor, New Yoga Centre, Department of Integrative Medicine, NIMHANS, Bangalore - 560029, Karnataka, India. |
| 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 |
| Dr Nandini M K |
NIMHANS |
1st floor, Yoga Centre, Department of Integrative Medicine, NIMHANS,
Bangalore, Karnataka
560029, India.
Bangalore
KARNATAKA |
9663937361
nandinimk73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee for Research in AYUSH and Integrative Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z55-Z65||Persons with potential health hazards related to socioeconomic and psychosocial circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults of age 18 years and above.
2.English, Hindi, Marathi or Kannada speaking, who have completed at least high school.
3.Those regularly attending tele-yoga sessions organized by NIMHANS Institute at least for last 1 year (with more than or equal to 60% attendance) or those who discontinued after joining initially (with less than 30% attendance and no tele-yoga sessions in last 1 year)
4.Those who give written informed consent for participation in the study
5.Broad-band internet connection and willingness to have interviews through video conference.
|
|
| ExclusionCriteria |
| Details |
1.Cognitive impairment.
2.Severe medical illness that prevents interviewing.
3.Impairment of auditory functions.
4.Psychosis or other severe mental illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Intrapersonal &interpersonal relationships.
2.Factors affecting adherence to tele yoga.
3.Quality of life
|
one time point
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Perceived Stress Scale(PSS).
2.Satisfaction with life. |
one-time point, no follow up. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The study includes
video conference interviews,
it will be conducted via online platform by using a structured interview guide
with open-ended questions. The open-ended questions to understand and address
how their intra-interpersonal relationship, quality of life and what factors
made them to adhere to the practice of yoga. The videoconference interviews will
be conducted by a single researcher and would last approximately up to 30
minutes. These digitally recorded interviews will be transcribed using a software Atlas Ti by the
researcher. We shall conduct qualitative analysis on Atlas Ti and employ a
reflexive thematic analysis, acknowledging subjectivity and
emphasize theme development. The six-step approach by Braun and Clarke(24) will guide the analysis. It will involve data familiarisation,
initial code creation, text coding, aggregating codes with supporting data,
grouping codes into themes, evaluating and revising themes and codes. Three
independent researchers will generate and agree on the codes.
In addition to the
qualitative data, participant scores on the WHO Quality of Life Scale will also be gathered to assess how they feel about their
quality of life, health, or other areas of life. Demographic and quantitative data will be
analysed by using SPSS software.
|