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CTRI Number  CTRI/2021/07/035274 [Registered on: 29/07/2021] Trial Registered Prospectively
Last Modified On: 26/07/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Yoga]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga based intervention to deal with psychological distress among family members of people involved in management of COVID- 19 
Scientific Title of Study   Development and evaluation of a yoga-based intervention program to deal with the psychological distress among family members of the healthcare workers engaged in the management of COVID-19 patients  
Trial Acronym  Yoga for COVID-19 distress (YOCODis) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr PIyush Ranjan 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 10 SRB Lab Department of Medicine All India Institute of Medical Sciences Ansari Nagar

South
DELHI
110029
India 
Phone  9268714198  
Fax    
Email  drpiyushdost@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr PIyush Ranjan 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 10 SRB Lab Department of Medicine All India Institute of Medical Sciences Ansari Nagar

South
DELHI
110029
India 
Phone  9268714198  
Fax    
Email  drpiyushdost@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr PIyush Ranjan 
Designation  Additional Professor  
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 10 SRB Lab Department of Medicine All India Institute of Medical Sciences Ansari Nagar

South
DELHI
110029
India 
Phone  9268714198  
Fax    
Email  drpiyushdost@gmail.com  
 
Source of Monetary or Material Support  
DST Satyam and Department of Medicine All India Institute of Medical Sciences  
 
Primary Sponsor  
Name  DST Satyam 
Address  Technology Bhavan, New Mehrauli Road, Block C, Qutab Institutional Area, New Delhi, Delhi 110016 
Type of Sponsor  Government funding agency 
 
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 
Dr Piyush Ranjan  All India Institute of Medical Sciences  Room no. 10 SRB Lab Department of Medicine
South
DELHI 
9268714198

drpiyushdost@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee, All India Institute of Medical Science, Ansari Nagar, New Delhi-110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers with no significant acute medical illness.  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard care  medical management if required and general counselling including dietary counseling and physical activity 
Intervention  Yoga with standard care   medical management if required and general counselling including dietary counseling and physical activity advice Yoga-based intervention: It will include 30 minutes of yogic exercises in addition to clinical features and associated distress and a follow- up on 6 months after the intervention  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Family members of the healthcare workers

Intend to follow up regularly will be included in the study

Individuals should be able to comprehend the instructions of a structured scale

Individuals who are able to read and write
 
 
ExclusionCriteria 
Details  Patients with Known psychiatric illnesses

Patients with significant psychiatric comorbidity warranting hospitalization
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement in mental well being as measured by DASS scores   6 months 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/08/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Background: The outbreak of the novel coronavirus, COVID-19, has been declared a Public Health Emergency. It has caused serious psychological distress stress, anxiety and depression in the general population, especially amongst asymptomatic and affected patients, healthcare workers, caregivers and family members. Amongst these, family members of healthcare workers is an important section of the society which might get overlooked. There is no treatment protocol to manage stress in this section during COVID pandemic. Yoga as an adjunct therapy with standard care has been useful in managing psychological distress in the general population.

Also, there is no evidence on the effect of yoga on management of stress among family members of healthcare workers. 

Rationale: The outbreak of COVID 19 has led to unprecedented strict quarantine measures to contain the virus in India, which is proving to be a threat to psychological wellbeing of the general population. Amongst these, family members of healthcare workers will be the worst affected. Moreover, temporary isolation faced by family members from healthcare staff might enhance their distress. These groups require effective counselling techniques to reduce psychological distress. Yoga is known to be an effective intervention in managing psychological distress. There is a lack of an integrated yoga based intervention module to deal with psychological distress amongst this section, which is simple, effective and can be easily instructed through the internet and practiced at home. Besides, quarantine and isolation in current time warrants development of a noble way of learning and practising yoga which is effective yet practical.

Hypothesis

We hypothesize that yoga-based intervention will be more effective in overcoming psychological distress during the time of pandemic family members of the healthcare workers engaged in the management of COVID 19 patients.

Primary objective

To study the effectiveness of yoga-based intervention in reducing the psychological distress among family members of healthcare workers engaged in management of COVID 19 patients.

Secondary objective

  1. To develop a yoga-based intervention to manage psychological distress in family members of healthcare workers engaged in management of COVID 19 patients.

Methodology: The aim of this study is to develop and evaluate the efficacy of yoga based intervention programs to manage psychological distress stress, depression and anxiety in family members of healthcare workers. The study will be conducted in three phases. Phase I will involve development of a yoga based intervention module by extensive literature review and focus group discussion with the experts. In phase II, 364 family members will be screened using Depression Anxiety Stress Scale DASS to be enrolled in the third phase of the study. Phase III is a randomised controlled trial RCT to assess the effectiveness of the devised yoga based intervention. In this RCT, we intend to recruit 54 family members. Twenty seven family members will receive yogic intervention with standard care and 27 family members will receive only standard care. The change in DASS scores will be studied post intervention as outcome measures.


Proposed Outcome The study will provide a yoga module which can be used to cope with distress among family members. The family members practicing this intervention will have improvement in physical and mental wellbeing and will become an effective support system for healthcare workers engaged in the management of COVID 19 patients.

This module can be further developed to be implemented in family members of patients suffering from chronic disease.


 
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