| 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
|
|
|
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
|
|
|
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 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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