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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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). 

 
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