| CTRI Number |
CTRI/2021/02/030897 [Registered on: 01/02/2021] Trial Registered Prospectively |
| Last Modified On: |
13/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Covid yoga practice among health care professionals having stress anxiety and depression |
|
Scientific Title of Study
|
A pilot project to evaluate efficacy of yoga intervention for stress, anxiety and depression among healthcare professionals working in a frontline COVID-19 tertiary care hospital of New Delhi |
| Trial Acronym |
CYP-HCP-SAD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R P Beniwal |
| Designation |
Associate Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences-Dr Ram Manohar Lohia Hospital |
| Address |
Room No.5 Department of Psychiatry, Centre of Excellence in Mental Health, ABVIMS & Dr. Ram Manohar Lohia Hospital, New Delhi Baba Kharag Singh Marg New Delhi Central DELHI 110001 India |
| Phone |
09811841351 |
| Fax |
|
| Email |
drrpbeniwal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr R P Beniwal |
| Designation |
Associate Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences-Dr Ram Manohar Lohia Hospital |
| Address |
Room No. 5 Department of Psychiatry, Centre of Excellence in Mental Health, ABVIMS & Dr. Ram Manohar Lohia Hospital, New Delhi Baba Kharag Singh Marg New Delhi Central DELHI 110001 India |
| Phone |
09811841351 |
| Fax |
|
| Email |
drrpbeniwal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr R P Beniwal |
| Designation |
Associate Professor |
| Affiliation |
Atal Bihari Vajpayee Institute of Medical Sciences-Dr Ram Manohar Lohia Hospital |
| Address |
Room No. 5 Department of Psychiatry, Centre of Excellence in Mental Health, ABVIMS & Dr Ram Manohar Lohia Hospital, New Delhi. Baba Kharag Singh Marg New Delhi Central DELHI 110001 India |
| Phone |
09811841351 |
| Fax |
|
| Email |
drrpbeniwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Funding from Department of science and Technology, Govt of India. |
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| 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 R P Beniwal |
Room No. 30 Department of Psychiatry, Centre of Excellence in Mental Health |
ABVIMS & Dr RML Hospital, Baba Kharag Singh Marg, New Delhi-110001 Central DELHI |
09811841351
drrpbeniwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ABVIMS,Dr RML Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F439||Reaction to severe stress, unspecified, (2) ICD-10 Condition: F439||Reaction to severe stress, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Yoga Intervention |
Yoga Training (YT): Participants will be imparted YT for twenty-one days, daily for one hour using a manualized protocol (Bhatia et al. 2012). On basis of this manualized protocol we designed this YT module for proposed project which includes postures or Asanas (exercises) and Pranayam (Breathing protocols). The yoga training will start with yogic prayer then shatkarma kriya like kapalbhati and trataka. We practice yogic sukshma and sthula vyayama for warm up the body and for proper joint movements. The asanas comprise of different postures; standing (Kati chakrasan, urdhva hastottanasana, vrikshasana, Trikonasan); supine (Setubandhasana, Naukasana, Urthsarvangasna, Savasana); prone (Makarasan, Bhujangasan, Shalabhasan, Dhanurasan); and sitting postures (Pashimottanasan, Gomukhasan, Vakrasana, Simhasana).
We planned this protocol for our participants and plan to include all forms of asanas (balancing postures, forward and backward bending, meditative and relaxation postures) in our training protocol. After asanas we will practice mudra and bandha followed by pranayam-ujjayi and bhramari. At the end of the session we will train our participants to practice dhyana (meditation). Our yoga protocol designed to include asanas in all positions- sitting, supine and prone position to provide maximum relaxation to participants which is essential for relieving COVID-19 related anxiety. The session will conclude with shanti patha (for wellness of all beings).
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Ability to provide written informed consent
2. Age between 21-60 years
3. Both genders
4. Healthcare Professionals (HP) {nursing officers, junior and senior doctors, paramedical personnel}
|
|
| ExclusionCriteria |
| Details |
1. Major mental illness
2. Those who are already on psychiatry treatment for stress, anxiety and depression
3. Active suicidality
4. Substance Dependence except social use of alcohol and nicotine
5. Pregnancy
6. Unwilling or inability to attend three weeks (at least 4 days a wk.) of yoga
7. Who have already participated in any other yoga studies or yoga training within last six months and/or those who do yoga regularly.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The project will advance ancient Indian therapies for decreasing stress and improving anxiety, depressive symptoms, quality of sleep. It would help to assess level of recent perceived stress, quality of sleep, level of anxiety and depression among healthcare professionals during covid-19 outbreak and to evaluate the effect of a protocolized yoga-meditation intervention in improving quality of sleep and treating stress, anxiety and depression among participants. |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We also anticipate improved physical, physiological and psychological fitness for our participants from our protocols. We also expect the enhancement of the immunity level of study participants after practicing of yogic intervention. Physiological (HR, RR, BP, PFT and SPO2), Physical parameters (weight, height, BMI, waist circumference),and for immune parameters (S. cortisol, S. Interleukin IL-4, 6, TNF-α and Interferon-γ) before and after training. |
One year |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/02/2021 |
| Date of Study Completion (India) |
14/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" 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)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a pilot feasibility study for health care professionals (HCP) with psychiatric symptoms, working in a frontline COVID-19 tertiary care treatment centre. Target symptoms will include sleep disturbance, and symptoms of stress, anxiety and depression. Healthcare professionals in frontline areas faced heavy stress load during the lockdown. The stress of working in the health care field leads to anxiety and depression as well as problems in sleep due to shift duties. Dr Ram Manohar Lohia Hospital has been a frontline treatment center for every epidemic as well as for COVID-19 outbreak since January 2020. Non-pharmacological management like yoga-meditation would provide some innovative solutions, scientiï¬cally recognized as effective methods to enhance quality of sleep, reduce stress, anxiety, depressive symptoms and improve physical work-related issues in healthcare professionals in such circumstances. Studies also reported the positive effect of yoga on body immunity. In this background we propose to investigate role of yoga training among doctors, nurses and paramedical health care professionals of Atal Bihari Vajpayee Institute of Medical Sciences & Dr Ram Manohar Lohia Hospital who consent to participate in the study. The aim of this study is to assess level of recent perceived stress, quality of sleep, symptoms of anxiety and depression among HCP during COVID-19 outbreak and to evaluate the effect of a 21 day protocolized yoga intervention. This will be a pilot study with pre and post evaluation among 50 HCP who score above the cut-off on the General Health Questionnaire (GHQ-60) at screening. The yoga intervention will last for three weeks (five days a week, for 60 minutes). A battery of psychological tests will be administered at baseline before training, and 4th and 8th week of post training. Data including physical, physiological and biochemical parameters will analysed with appropriate statistical application. We will also interview our participants to obtain their views of the benefits, drawbacks if any, and suggestions about yoga training.
Along with detailed socio-demographic information, all those who provide consent will be assessed at baseline on Global Assessment of Recent Stress scale (GARS), Pittsburg Sleep Quality Index (PSQI), HAM-A and HAM-D to check level of stress, quality of sleep, anxiety and depression respectively. The intervention will last for three weeks, five days a week, for one hour daily. All participants will be again assessed on GARS, PSQI, HAM-A and HAM-D within seven days of completion of yoga intervention. This will be their first post intervention assessment. Participants will be advised to continue their yoga practice learned in these sessions at their home regularly for the next one month. They will be re-assessed on all the parameters after one more month (second post intervention assessment) to evaluate the sustainability of effect of yoga on psychological, physiological and biochemical components. |