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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  
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 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  
Status 
Not Applicable 
 
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, scientifically 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. 

 
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