| CTRI Number |
CTRI/2021/02/031331 [Registered on: 16/02/2021] Trial Registered Prospectively |
| Last Modified On: |
15/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Yoga on wellbeing in undergraduate healthcare students |
|
Scientific Title of Study
|
Effect of Yoga on wellbeing in undergraduate healthcare students: A salutogenic approach |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushant Bharat Singh |
| Designation |
PhD Scholar |
| Affiliation |
Sri Balaji Vidyapeeth |
| Address |
Center for Yoga Therapy Education & Research (CYTER), 1st floor, I Block
Mahatma Gandhi Medical College, Sri Balaji Vidyapeeth
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8600747781 |
| Fax |
|
| Email |
sushantsingh8@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meena Ramanathan |
| Designation |
Deputy Director & Associate Professor |
| Affiliation |
CYTER, Sri Balaji Vidyapeeth |
| Address |
CYTER, 1st floor, I Block
Mahatma Gandhi Medical College, Sri Balaji Vidyapeeth
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8600747781 |
| Fax |
|
| Email |
saineema@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meena Ramanathan |
| Designation |
Deputy Director & Associate Professor |
| Affiliation |
CYTER, Sri Balaji Vidyapeeth |
| Address |
CYTER, 1st floor, I Block
Mahatma Gandhi Medical College, Sri Balaji Vidyapeeth
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8600747781 |
| Fax |
|
| Email |
saineema@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Balaji Vidyapeeth |
| Address |
Pondicherry Cuddalore EC road,
Pillayarkuppam, Puducherry- 607402
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Sushant Singh |
CYTER of Sri Balaji Vidyapeeth |
1st floor, I Block
MGMCRI, Pillayarkuppam,
Pondicherry
PONDICHERRY |
8600747781
sushantsingh8@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committe, Mahatma Gandhi Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Undergraduate Healthcare Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Undergraduate Healthcare students who will not be a part of yoga training in these 6 months |
| Intervention |
Yoga |
Regular weekly guided 90 minutes yogabhyasa for 6 months |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
a)Undergraduate healthcare students studying at Sri Balaji Vidyapeeth
b) Age: 17 years to 21 years
c) Can understand & communicate in the English language
|
|
| ExclusionCriteria |
| Details |
a) Under regular medication for any chronic conditions (e.g. Diabetes, Hypertension, Asthma, Thyroid, psychiatric disorders, etc.)
b) Regularly practising Yoga
c) Any recent surgery
d) Inability to perform the Practices
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of guided yoga training in healthcare students on
1) Physiological parameters: Handgrip strength (HGS) and handgrip endurance (HGE), Resting Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Heart Rate (HR)
2) Psychological parameters: General Well-being Scale (GWBS), Perceived Stress Scale (PSS), WHO Quality of Life Bref (WHOQOL-Bref)
3) Body Composition
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
N/A |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
20/02/2021 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sushantsingh8@hotmail.com].
- For how long will this data be available start date provided 01-04-2022 and end date provided 31-03-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Introduction: High levels of stress have been identified in healthcare students. As stress can affect psychophysiological well-being which can interfere with learning and clinical performance, there is a clear argument for universities to include healthcare students’ well-being as an outcome in the core curriculum. Yoga can be a great tool as it is inexpensive, potentially rewarding, and safe when taught by experienced certified trainers. In this controlled trial we shall study the effect of regular weekly guided Yoga for healthcare students done over a period of 6 months on physical and mental wellbeing. The results of this study may help generate public interest to introduce yoga as a regular activity in colleges & universities and help the general health of society at large.
Objectives: To evaluate the effect of guided yoga training in healthcare students on 1) Physiological parameters: Handgrip strength (HGS) and handgrip endurance (HGE), Resting Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and Heart Rate (HR) 2) Psychological parameters: General Well-being Scale (GWBS), Perceived Stress Scale (PSS), WHO Quality of Life Bref (WHOQOL-Bref) 3) Body Composition.
Hypothesis: Regular weekly guided Yogabhyasa will improve Physical and Mental wellbeing in undergraduate healthcare students
SUBJECTS AND METHODS: The present study will be conducted with undergraduate (UG) healthcare students studying in Sri Balaji Vidyapeeth (SBV), Pondicherry. After fulfilling the inclusion and exclusion criteria, subjects will be informed about the study and their consent will be taken. There will be two study groups, Group A and Group B. Group A will be undergoing 90 minutes of Yoga Training once a week for a period of 6 months. Whereas group B will be controlled and will not be a part of yoga training in these 6 months. Physiological, psychological and anthropometric parameters will be recorded for all participants before and after the study period.
|