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CTRI Number  CTRI/2024/09/074132 [Registered on: 20/09/2024] Trial Registered Prospectively
Last Modified On: 09/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga for mental health of healthcare workers 
Scientific Title of Study   Efficacy of 4-week yoga module on sympatho-vagal balance among healthcare workers in a tertiary care hospital: a randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anita Verma 
Designation  PhD Scholar 
Affiliation  All India Institute of Medical Sciences Rishikesh, Uttarakhand  
Address  Department of Community and Family Medicine, AIIMS Rishikesh, Virbhadra Marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9997454915  
Fax    
Email  anita.v.9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vartika Saxena 
Designation  Guide, Professor and HOD 
Affiliation  All India Institute of Medical Sciences Rishikesh, Uttarakhand  
Address  Department of Community and Family Medicine, AIIMS Rishikesh, Virbhadra Marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9997454915  
Fax    
Email  vartika.cfm@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query
 
Name  Anita Verma 
Designation  PhD Scholar 
Affiliation  All India Institute of Medical Sciences Rishikesh, Uttarakhand  
Address  Department of Community and Family Medicine, AIIMS Rishikesh, Virbhadra Marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  9997454915  
Fax    
Email  anita.v.9@gmail.com  
 
Source of Monetary or Material Support  
Defence Institute of Physiology and Allied Sciences (DIPAS), Life Sciences Research Board (LSRB), Defence Research and Development Organisation (DRDO), Delhi-110054, India 
 
Primary Sponsor  
Name  AIIMS Rishikesh 
Address  All India Institute of Medical Sciences (AIIMS) Rishikesh, Virbhadra Road, Rishikesh-249203, Uttarakhand, India  
Type of Sponsor  Research institution and hospital 
 
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 Vartika Saxena  AIIMS Rishikesh  Room no-21, Level-5, Department of Community and Family Medicine, AIIMS Rishikesh, Virbhadra Road, Rishikesh-249203
Dehradun
UTTARANCHAL 
9997454915

vartika.cfm@aiimsrishikesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Rishikesh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sympathovagal balance 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  30-minute medium paced walking  Intervention for this group will consist of 30-minute medium paced walking by the participants for a duration of a minimum of five days per week over a four-week period. This includes “purposeful walking at a pace of 3–6 km/hr (i.e. 1500-3000 meter in 30 minutes) on level firm ground which elicits a moderate, noticeable increase in depth and rate of breathing while still allowing comfortable talking and is relative to a given individual”. 
Intervention  30-minute yoga module developed by DIPAS  Intervention for this group of participants will consist of a validated 30-minute yoga module developed by DIPAS, comprising of loosening exercises, asanas, breathing technique and meditative practices for a minimum of 5 days per week for a total duration of 4 weeks. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Following participants will be included:

a) male and female healthcare workers of AIIMS Rishikesh
b) age range 19-60 years 
 
ExclusionCriteria 
Details  Participants having any of the following condition will be excluded:

a) pregnant women
b) any surgery in past 3 months
c) physical inability to perform yoga module
d) cardiac conditions or abnormalities that could affect HRV measurements, such as arrhythmias, atrial fibrillation, heart failure, or structural heart disease
e) participants in intervention group already doing medium paced walking
f) participants already practicing yoga
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome:
To compare change in heart rate variability (HRV) among participants undergoing DIPAS yoga intervention versus medium paced walking for 4 weeks.

HRV measurements will consist of the following components-
a) Time domain analysis- RR interval, Root Mean Square of Successive Differences between normal heartbeats (RMSSD) and 30:15 ratio.
b) Frequency domain analysis- Low Frequency Power (LF), High Frequency Power (HF) and LF/HF Ratio. 
To measure long term effects, HRV measurements will be done at baseline and after 4 weeks.

To measure short term effects, HRV measurements will be done pre and post intervention on Day 1, Day 14 and Day 28. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes:
To assess the efficacy of DIPAS yoga module as compared to medium paced walking intervention among healthcare workers for immediate change in-
a) state anxiety
b) selective attention 
Short term effects on state anxiety & selective attention will be measured at the start of intervention, at 2 weeks & at 4 weeks. 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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)   23/09/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The concept of sympatho-vagal balance (SVB) shows how our body’s autonomic system is affected by both the sympathetic (fight or flight) and parasympathetic (rest and digest) influences, essentially indicating the balance between these two systems. The balance between these two systems is crucial for maintaining homeostasis in the body, and an imbalance can lead to various health issues including cardiovascular diseases, gastrointestinal disorders, and mental health problems. Research has extensively investigated SVB using various techniques such as heart rate variability (HRV).

The fluctuation in the time intervals between adjacent heartbeats is referred to as HRV. It is a measure of the dynamic interactions between heart and brain, influenced by the autonomic nervous system. In simpler terms, HRV provides insights into the coordination between heart and brain, influencing various aspects of the body’s functioning. HRV analysis techniques can distinguish between the activation of the parasympathetic nervous system, indicating a relaxed state that reflects good health, and the sympathetic nervous system, indicating an agitated state that, when persistently activated, leads to ill health.

Healthcare workers (HCWs) actively involved in patient care at tertiary care hospitals face significant stress and workload, which may adversely impact their overall well-being, including cardiovascular health. According to Joseph and Joseph (2016) “A healthcare worker is one who delivers care and services to the sick and ailing either directly as doctors and nurses or indirectly as aides, helpers, laboratory technicians, or even medical waste handlers”. World Health Organization (WHO) classifies healthcare workers into five broad categories: a) health professionals; b) health associate professionals; c) personal care workers in health services; d) health management and support personnel and; e) other health service providers not elsewhere classified. This classification is provided in table-1 below:

Table 1: Classification of healthcare workers according to WHO

S.no.

Classification

Occupational Group

1.      

Health professionals

Generalist medical practitioners, Nursing professionals, Paramedical practitioners, Pharmacists

2.      

Health associate professionals

Medical technicians, Nursing associate professionals, Ambulance workers, Counsellors

3.      

Personal care workers in health services

Health care assistants, First-aid attendant, Hospital orderly, Medical imaging assistant, Phlebotomist, Sterilization aide

4.      

Health management and support personnel

Health service managers, Clerical workers, Plant and machine operators and assemblers

5.      

Health service providers not elsewhere classified

Medical student intern, Hospital volunteer

 

HCW’s often face substantial stressors in their professional environments, which can significantly impact their SVB. The demanding nature of healthcare duties, including long working hours, emotional strain, and exposure to high-pressure situations, can lead to chronic sympathetic activation and reduced parasympathetic tone among healthcare workers. Prolonged imbalance in sympathovagal activity has been associated with increased risk of cardiovascular disease, impaired immune function, and psychological distress, highlighting the importance of implementing strategies to support the well-being of healthcare professionals.

The dynamic interaction of SVB has frequently been associated with a variety of mind-body interventions, including yoga practices. Yoga, with its multifaceted approach encompassing physical postures, breath control, and meditation, has been suggested to influence autonomic nervous system function and, consequently, SVB. The mechanisms through which yoga influences SVB are multifaceted. Respiratory modulation, a key component of many yogic practices, is believed to play a pivotal role. Additionally, the mind-body connection fostered by yoga practices may impact the central nervous system, further influencing SVB.

Hence, the purpose of the present study is to assess the efficacy of a yoga module (consisting of asana, pranayama and relaxation & meditative practices) developed by Defence Institute of Physiology & Allied Sciences (DIPAS) [Defence Research and Development Organisation (DRDO), Ministry of Defence, Government of India] on SVB among HCWs in a tertiary care hospital. This module is henceforth referred to as DIPAS yoga module. It incorporates a comprehensive approach that combines physical postures, controlled breathing techniques, and mindfulness practices, aligning with the purpose of stress reduction. This module has been validated with content validity ratio (CVR) of 0.89 and an intra-class correlation of 0.78.

 
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