| CTRI Number |
CTRI/2018/03/012338 [Registered on: 05/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
05/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The effect of yoga and meditation on stress among healthcare workers |
|
Scientific Title of Study
|
The effect of yoga and meditation on coping strategies among healthcare workers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chethan Singh H |
| Designation |
Post Graduate Student |
| Affiliation |
Prasanna School of Public Health |
| Address |
Prasanna School of Public Health
Udupi
KARNATAKA
576104
India |
| Phone |
8884797879 |
| Fax |
|
| Email |
drchethansingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Bryal Dsouza |
| Designation |
Asst Professor |
| Affiliation |
Prasanna School of Public Health |
| Address |
Prasanna School of Public Health Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9900405393 |
| Fax |
|
| Email |
brayal.dsouza@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chethan Singh H |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Prasanna School of Public Health |
| Address |
Prasanna School of Public Health Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8884797879 |
| Fax |
|
| Email |
drchethansingh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
prasanna school of public health |
| Address |
prasanna school of public health manipal |
| Type of Sponsor |
Research institution |
|
|
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 CHETHAN SINGH H |
KASTURBA HOSPITAL MANIPAL |
Dept of Yoga, opp nursing hostel
KASTURBA HOSPITAL MANIPAL
Udupi
KARNATAKA |
8884797879
drchethansingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee kasturba hospital manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Yoga,Meditation and Stress |
Intervention is related to the effect of yoga and meditation on stress level.
Hatha Yoga techniques,cyclic meditation and MSRT are used.
Total five sessions are given,
each session for 90mins..
Total duration of the study is 6 months.
Drugs are not used in this study. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
HEALTHCARE WORKERS THOSE WHO ARE WILLING TO TAKE PART IN THE STUDY |
|
| ExclusionCriteria |
| Details |
HEALTHCARE WORKERS THOSE WHO ARE NOT WILLING TO TAKE PART IN THE STUDY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| STRESS MANAGEMENT |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Healthy Living |
4 months |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="90"
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)
|
19/01/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Distributing questionnaire to the healthcare workers to assess the stress level. Teaching Yoga and Meditation classes to those who got high stress score. Again distributing stress questionnaire to know the effect of Yoga and Meditation classes on stress management. |