| CTRI Number |
CTRI/2018/02/012206 [Registered on: 28/02/2018] Trial Registered Prospectively |
| Last Modified On: |
28/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of yoga on stress among nursing staff in a tertiary care hospital. |
|
Scientific Title of Study
|
Effect of structured yoga program on stress and professional quality of life among selected nursing staff in a tertiary care hospital of Delhi - A small scale phase-II trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Puneet Misra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Centre for Community Medicine,
OLD OT block,
AIIMS, Ansarinagar.
South West
DELHI
110029
India |
| Phone |
9810696386 |
| Fax |
|
| Email |
doctormisra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suprakash Mandal |
| Designation |
Junior resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Centre for Community Medicine,
OLD OT block,
AIIMS, Ansarinagar
South West
DELHI
110029
India |
| Phone |
7318922150 |
| Fax |
|
| Email |
hasnudotcom@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suprakash Mandal |
| Designation |
Junior resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Centre for Community Medicine,
OLD OT block,
AIIMS, Ansarinagar
South West
DELHI
110029
India |
| Phone |
7318922150 |
| Fax |
|
| Email |
hasnudotcom@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Puneet Misra |
| Address |
Room no-35, Centre for Community Medicine, Old OT Block, AIIMS, New Delhi-110029 |
| 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 Puneet Misra |
AIIMS |
AIIMS, Ansarinagar
South West
DELHI |
9810696386
doctormisra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Under variable perceived stress and professional quality of life. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal day to day activity. |
The comparator group will be wait-list control group. They will not do any practice but they will be offered Yoga for 3 months (from 3rd month to 6th month). |
| Intervention |
Structured Yoga |
Intervention group will practice structured Yoga under supervision of professional yoga expert 2 sessions of 50 minutes each per week at CIMR, AIIMS and 3 sessions of same duration at their home for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
All in service nursing staff working at AIIMS for at least a year. |
|
| ExclusionCriteria |
| Details |
Those who are already under pharmacological treatment for stress and anxiety disorder at the time of enrolment.
Those who are not able to do Yoga due to any reason.
Who are going to retire in next year.
Those who will not willing to consent for blood investigations.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change of perceived stress and professional quality of life. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sustainability of this structured yoga program. |
3rd to 6th months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "113"
Final Enrollment numbers achieved (India)="113" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/03/2018 |
| Date of Study Completion (India) |
25/07/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study will be done to see whether structured yoga practice has a potential to reduce perceived stress or not beside improving professional quality of life. As a secondary objective sustainability of yoga programme may be assessed. The study design is a small-scale randomized controlled trial of phase II. In service nursing staff of AIIMS hospital, New Delhi will be the study population. Sample size will be total 100, 50 in each arm. The total study period will be of 6 months, wherein 1st 3-month intervention group will practice yoga both at CIMR, AIIMS and at home. The second or the wait-list control group will do nothing at that time period. The 2nd group will be offered yoga at CIMR for another 3 months and that time the 1st group will be asked to practice at home. Periodic assessment ( at 0th, 3rd and 6th month) of their perceived stress level (using PSS-10 questionnaire) and professional quality of life ( using PrOQOL questionnaire) will be done along with some baseline blood investigations (Hb%, FBS, PPBS, HbA1c, lipid profile, CRP, ESR, serum cortisol) will be carried out. After collecting all the data they will be analyzed using an appropriate statistical method and be compared. |