跳至主要内容
临床试验/CTRI/2024/09/074132
CTRI/2024/09/074132进行中(未招募)不适用

Efficacy of 4-week yoga module on sympatho-vagal balance among healthcare workers in a tertiary care hospital: a randomized controlled trial

AIIMS Rishikesh1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年9月23日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
108
试验地点
1
主要终点
Primary outcome:

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
19.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Following participants will be included: a) male and female healthcare workers of AIIMS Rishikesh b) age range 19-60 years.

排除标准

  • 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.

结局指标

主要结局

Primary outcome:

时间窗: 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.

To compare change in heart rate variability (HRV) among participants undergoing DIPAS yoga intervention versus medium paced walking for 4 weeks.

时间窗: 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.

HRV measurements will consist of the following components-

时间窗: 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.

a) Time domain analysis- RR interval, Root Mean Square of Successive Differences between normal heartbeats (RMSSD) and 30:15 ratio.

时间窗: 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.

b) Frequency domain analysis- Low Frequency Power (LF), High Frequency Power (HF) and LF/HF Ratio.

时间窗: 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.

次要结局

  • Secondary outcomes:(To assess the efficacy of DIPAS yoga module as compared to medium paced walking intervention among healthcare workers for immediate change in-)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anita Verma

All India Institute of Medical Sciences Rishikesh, Uttarakhand

研究点 (1)

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