| CTRI Number |
CTRI/2020/07/026609 [Registered on: 15/07/2020] Trial Registered Prospectively |
| Last Modified On: |
15/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoganidra benefits on COVID health care workers |
|
Scientific Title of Study
|
Effect of Yoganidra on COVID health care workers: Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mallikarjun Gunjiganvi |
| Designation |
Assistant Professor of Trauma Surgery |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
620, Faculty Block,
Apex Trauma Center,
SGPGIMS,
Lucknow- 226014
Dept. of Critical Care Medicine,
SGPGIMS, Lucknow- 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004900947 |
| Fax |
|
| Email |
gunjiganvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mallikarjun Gunjiganvi |
| Designation |
Assistant Professor of Trauma Surgery |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
620, Faculty Block,
Apex Trauma Center,
SGPGIMS,
Lucknow- 226014
Dept. of Critical Care Medicine,
SGPGIMS, Lucknow- 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004900947 |
| Fax |
|
| Email |
gunjiganvi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mallikarjun Gunjiganvi |
| Designation |
Assistant Professor of Trauma Surgery |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
620, Faculty Block,
Apex Trauma Center,
SGPGIMS,
Lucknow- 226014
Dept. of Critical Care Medicine,
SGPGIMS, Lucknow- 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004900947 |
| Fax |
|
| Email |
gunjiganvi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGPGIMS |
| Address |
SGPGIMS, Rae Bareli Road,
Lucknow- 226014 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mallikarjun Gunjiganvi |
SGPGIMS |
Faculty Block, Apex Trauma Center, SGPGIMS,
Rae Bareli Road,
Lucknow- 226014
Lucknow
UTTAR PRADESH |
05222496701
gunjiganvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COVID Health Care Workers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SUPINE RELAXATION MUSIC |
SUPINE RELAXATION is state of lying down in supine position and listening to the sleep relaxation music.
Frequency -On daily basis at a suitable and convenient time due to multiple shift nature of duty hours (inherent to COVID infection)
Time: Administered daily for 30 minutes duration |
| Intervention |
YOGANIDRA |
YOGANIDRA is state of Conscious sleep performed by lying down in supine position. In this technique, participants will be awake and are aware about the different body parts.
Frequency -On daily basis at a suitable and convenient time due to multiple shift nature of duty hours (inherent to COVID infection)
Time: Administered daily for 30 minutes duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Covid health care workers in the frontline of COVID-19 duty (Physicians, Residents and Staff Nurses) willing to participate in the study and should have the knowledge of English Language
|
|
| ExclusionCriteria |
| Details |
Covid health care workers who become symptomatic of COVID-19 disease during the study period needing hospitalization. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Impact of Yoganidra on Depression, Anxiety and Insomnia among
Covid Warriors using: Patient Health Questionnaire (PHQ-9) scale; Generalized Anxiety Disorder (GAD-7) scale; 7-item Insomnia Severity Index scale. |
Baseline, 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feasibility of Study |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/07/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
COIVD19, a pandemic of 2020 is requiring dedicated professional health care workers due to highly
contagious nature of this disease. Due to this, COVID warriors are experiencing emotional and
psychological problems like stress, anxiety, depression and insomnia including post traumatic stress
disorders. Among many therapies (psychotherapy and Mind Body Therapy) available including
Yoganidra have been studied and documented to decrease stress and anxiety, and improve general
well being among PTSD and insomnia patients. However, search for effect of Yoganidra on covid19
warriors is not available in the literature (PUBMED). Hence, a pilot study is planned to assess the
impact of Yoganidra. This study is an open label randomized controlled trials. It consists of 2 groups
each 30 participants: a) Yoganidra group and b) Sleep relaxation group. Health care workers having
covid duty will be contacted telephonically 1 day prior to start of duty and study will be explained in
detail. Consented participants will be block randomized and allotted to particular therapy. They will
be given respective therapy demonstration and video link of each therapy will be sent to them.
Baseline characteristics, GAD-7 scale, PHQ-9 scale and Insomnia Severity Index score will be
recorded. They will be given respective therapy during covid duty and during quarantine period if
quarantine is applicable as per hospital policy. GAD-7 scale, PHQ-9 scale and Insomnia Severity
Index scores will be assessed at the end of covid duty and quarantine period and compared to the
baseline between intra-group and inter-groups. Outcomes will be assessed for level of Depression,
Anxiety and Insomnia among covid health care workers over the period in both the groups. |