| 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
|
|
|
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
|
|
|
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 individualâ€. |
| 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 handlersâ€. 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. |