| CTRI Number |
CTRI/2021/09/036594 [Registered on: 17/09/2021] Trial Registered Prospectively |
| Last Modified On: |
26/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pranayama and yoga for well-being of healthcare workers |
|
Scientific Title of Study
|
Effectiveness of pranayama and yoga-based interventions on the well-being of healthcare professionals |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Balaji Bharadwaj |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room 1081 Ground Floor
Hospital Block
JIPMER Hospital
Dhanvantri Nagar
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132296282 |
| Fax |
|
| Email |
bharadwaj.balaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balaji Bharadwaj |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room 1081 Ground Floor
Hospital Block
JIPMER Hospital
Dhanvantri Nagar
Puducherry
PONDICHERRY
605006
India |
| Phone |
04132296282 |
| Fax |
|
| Email |
bharadwaj.balaji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balaji Bharadwaj |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Room 1081 Ground Floor
Hospital Block
JIPMER Hospital
Dhanvantri Nagar
Puducherry
PONDICHERRY
605006
India |
| Phone |
04132296282 |
| Fax |
|
| Email |
bharadwaj.balaji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, Government of India |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| Address |
Technology Bhavan,
New Delhi - 110016. |
| Type of Sponsor |
Government funding agency |
|
|
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 Balaji Bharadwaj |
Department of Psychiatry |
Room 1081, Ground Floor, Hospital Block,
JIPMER Hospital,
Dhanvantri Nagar,
Pondicherry
PONDICHERRY |
04132296282
bharadwaj.balaji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institute Ethics Committee for Human Studies (Interventional) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthcare professionals. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Workshop |
Comprehensive package consisting of Yogasanas, Pranayama with cyclical breathing techniques, Methods to handle stressful situations.
Intervention is given over four-days, followed by daily self-practice for 12 weeks. |
| Comparator Agent |
Pranayama and Mindfulness |
Pranayama - Alternate nostril breathing and Mindfulness technique
Intervention is delivered in a single session, followed by daily self-practice for a period of 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthcare workers including doctors, nursing officers, laboratory technicians and nursing attendants working in any healthcare facility in India
2. Age between 18 to 60 years
3. Should be able to read and comprehend English |
|
| ExclusionCriteria |
| Details |
1. Those who are already regular practitioners of Sudarshan Kriya or any meditation technique and have been practicing it regularly, i.e. three or more days per week within the last 3 months
2. Those who have pre-existing severe mental illnesses such as Bipolar disorder or schizophrenia
3. Those who have epilepsy will be excluded
4. Participants who have been diagnosed to have active tuberculosis as per self-report
5. Pregnancy and first 6-months postpartum
6. Uncontrolled hypertension defined as BP > 160/110 mmHg despite taking medications - by self-report
7. Heart disease – myocardial infarction within last 3 months or unstable angina or congestive heart failure by self-report
8. Only one person from the same family will be allowed to participate in the study to prevent contamination |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in depressive, anxiety and stress levels (on DASS-21 scale) |
Baseline, 2 weeks, 6 weeks, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Resilience (Connor-Davidson Resilience Scale) |
Baseline, 2 weeks, 6 weeks, 12 weeks |
| Sleep Quality (Pittsburgh Sleep Quality Index) |
Baseline, 2 weeks, 6 weeks, 12 weeks |
| Burnout (Oldenburg Burnout Inventory) |
Baseline, 2 weeks, 6 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="296"
Sample Size from India="296"
Final Enrollment numbers achieved (Total)= "63"
Final Enrollment numbers achieved (India)="63" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2021 |
| Date of Study Completion (India) |
19/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
19/09/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
No publications yet. The study has not begun. The study aims to note the difference in the reduction of stress, anxiety and depression, and burnout as well as improvement in sleep and resilience of healthcare workers who undergo a comprehensive four day workshop versus those who undergo single pranayama for well being |