| CTRI Number |
CTRI/2020/07/026799 [Registered on: 25/07/2020] Trial Registered Prospectively |
| Last Modified On: |
15/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga for Nurses (COVID-19) |
|
Scientific Title of Study
|
Effect of integrated Yoga on fear, stress, anxiety, sleep and quality of life among nurses working in COVID-19 hospital |
| Trial Acronym |
COVID-19 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Patil NJ |
| Designation |
Associate Professor and incharge HoD Integrative Medicine |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka |
| Address |
Dept. of Integrative Medicine
Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
9886211008 |
| Fax |
|
| Email |
ayushnitin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Patil NJ |
| Designation |
Associate Professor and incharge HoD Integrative Medicine |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka |
| Address |
Dept. of Integrative Medicine
Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
9886211008 |
| Fax |
|
| Email |
ayushnitin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Patil NJ |
| Designation |
Associate Professor and incharge HoD Integrative Medicine |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka |
| Address |
Dept. of Integrative Medicine
Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka
Kolar
KARNATAKA
563103
India |
| Phone |
9886211008 |
| Fax |
|
| Email |
ayushnitin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Patil NJ
Associate Professor & In-charge,HoD - Integrative Medicine
Sri Devaraj Urs Academy of Higher Education and Research Kolar Karnataka - 563103
Mob:98862 11008
Email: ayushnitin@gmail.com |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education and Research Kolar Karnataka |
| Address |
Dept. of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka- 563013 |
| Type of Sponsor |
Other [A Deemed to be University ] |
|
|
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 Patil NJ |
R L Jalappa Hospital and Research Center Tamaka Kolar |
Dept. of Integrative Medicine
Room No. 413
Fourth Floor
R L Jalappa Hospital and Research Center Tamaka Kolar, Karnataka
Kolar
KARNATAKA |
9886211008
ayushnitin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Devaraj Urs Medical College Kolar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nurses working in COVID-19 Hospital |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Yoga |
Group 1 : Integrated Yoga
1.Loosening Exercises
(Neck movements, Shoulder rotation, Twisting, Forward and backward bending)
2.Hand in and out breathing
Hand stretch breathing
3.Suryanamaskar
4.Nadishuddi and Bhramari
Pranayama
5.Deep Relaxation Technique
|
| Comparator Agent |
No specific Intervention |
No specific Intervention Routine day today activities will carry out |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Female nurses working in COVID-19 hospital with minimum 1 month of working history.
2. Age 21 to 50 years
3.Employed at the hospital at least six months
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy and lactating mother
2.Practiced Yoga in last 3 months
3.Underwent recent surgery
4. Any other severe illness
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Depression, Anxiety, Stress scale-21 (DASS-21)
Fear of COVID-19 scale
Perceived Stress Scale (PSS)
Pittsburgh Sleep Quality Index (PSQI) |
Day 01
Day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| WHO Quality of Life – BREF (WHOQOL-BREF) |
Day 01
Day 42 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/08/2020 |
| Date of Study Completion (India) |
31/03/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
COVID-19 is highly contagious, lack of known treatment and vaccination further provoked psychological disturbance especially in healthcare professionals. Nurses are the one who spend most of the time with patients seems to be psychologically disturbed due to nature of the disease. Yoga is an ancient mind-body therapy emerged as instrument for boosting the immunity and treating psychosomatic diseases. Ministry of AYUSH recommended Yoga in this testing time.
|