| CTRI Number |
CTRI/2020/10/028485 [Registered on: 20/10/2020] Trial Registered Prospectively |
| Last Modified On: |
19/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Yoga for COVID-19 healthcare workers |
|
Scientific Title of Study
|
EFFICACY OF INTEGRATED YOGA INTERVENTION ON PHYSIOLOGICAL AND PSYCHOLOGICAL OUTCOMES OF COVID-19 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 Satyapriya Maharana |
| Designation |
Associate Professor |
| Affiliation |
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Bangalore |
| Address |
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University,Anekal, Jigani, Bangalore
Bangalore KARNATAKA 560105 India |
| Phone |
8618587448 |
| Fax |
|
| Email |
trisatyapriya77@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Satyapriya Maharana |
| Designation |
Associate Professor |
| Affiliation |
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Bangalore |
| Address |
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University,Anekal, Jigani, Bangalore
Bangalore KARNATAKA 560105 India |
| Phone |
8618587448 |
| Fax |
|
| Email |
trisatyapriya77@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Pragya Jain Shrimal |
| Designation |
PhD Scholar(Yoga) |
| Affiliation |
Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Bangalore |
| Address |
Department of yoga and life science, Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Anekal, Jigani, Bangalore
Bangalore KARNATAKA 560105 India |
| Phone |
9425187845 |
| Fax |
|
| Email |
pragyajain11@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1) MTH, Hospital Indore 2)Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Bangalore |
|
|
Primary Sponsor
|
| Name |
Pragya Jain Shrimal |
| Address |
220, clerk colony, opp to Bhandari Hospital pardeshi pura Indore (M.P.) |
| Type of Sponsor |
Other [Self Funding] |
|
|
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 |
| Pragya Jain Shrimal |
MTH, Hospital |
Mahatma Gandhi Rd, Siyaganj, Indore Indore MADHYA PRADESH |
9425187845
pragyajain11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SVYASA Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COVID-19 Healthcare Workers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group Participants - Routine care activity |
Participants in the control group will follow their Routine care activity. |
| Intervention |
Yoga modules for management of coronavirus disease 2019 |
Integrated yoga-based intervention - delivered for 1 month. Supervised classes will be conducted for 60 minutes every Sunday by Yoga therapist to teach the techniques of Yoga. Participants will be provided Flow charts, Diagrams & Audio-Visual aid for doing self-practice every day for a minimum of 20 minutes at least 3 days per week. Participants will be provided a Monthly chart & Pen to maintain record of their self-practice. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Inclusion of population working in COVID-19 healthcare setup in MTH Hospital Indore.
2) Including Doctors, Nursing staff and Nursing orderly. |
|
| ExclusionCriteria |
| Details |
1) Unwilling for participation.
2) Medical restriction for physical movement.
3) History of recent surgery.
4) Severe Comorbid conditions (Uncontrolled Diabetes, Uncontrolled Hypertension and Cardiac diseases, COPD etc.)
5) Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oxygen Saturation, Heart Rate, Respiratory Rate and Blood pressure |
Day 1 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Stress, Anxiety, Fear, Sleep quality, Quality of life,
Repetitive Negative Thinking |
Day 1 and Day 30 |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/11/2020 |
| Date of Study Completion (India) |
22/12/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
COVID-19 is an infectious
disease caused by recently discovered novel coronavirus (World Health Organization, 2020a). Coronaviruses
are a large family of viruses which may cause illness in animals or humans. In
humans, several coronaviruses are known to cause respiratory infections ranging
from the common cold to more severe diseases such as Middle East Respiratory
Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) (National Health Mission, 2020). The most
recently discovered coronavirus causes coronavirus disease COVID-19 (World Health Organization, 2020).
Medical staffs are the backbone of the fight in the first
line of epidemic prevention and control, endure heavy work tasks, high risk of
infection and work pressure (Wu et al., 2020). Medical staff is facing work
pressure and psychological pressure, which may have a certain impact on their
emotional state and engender psychological stress (Duan et al.,
2020). During the COVID-19 outbreak, medical health workers had
psychosocial problems and risk factors for developing them (W. R. Zhang et
al., 2020). Yoga
and mindfulness administered together seem to be effective to reduce stress and
anxiety in healthcare workers, providing them with more consciousness and
ability to manage work stressful demands (La Torre et al., 2020). The
Harvard Medical School in the US has recommended yoga, meditation and
controlled breathing to address anxiety issues related to the novel coronavirus (Sharp,
2020). |