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临床试验/CTRI/2024/07/071645
CTRI/2024/07/071645进行中(未招募)4 期

An open-label, prospective, randomized controlled, single-centre pilot study evaluating the acceptability, feasibility and exploratory efficacy of transcendental meditation intervention for healthcare professionals in a tertiary care hospital in rural Jndia.

SMSIMSR, Sri Sathya Sai University for Human Excellence1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2024年8月20日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
76
试验地点
1
主要终点
Feasibility and acceptability of TM

研究概览

简要总结

Background: Health Care Professionals (HCPs) experience substantial stress, anxiety and burnout, with recently reported burnout rates of 60% to 70%. The World Health Organization (WHO) defines burnout as an occupational phenomenon resulting from chronic workplace stress that has not been successfully managed. Several randomized clinical trials have evaluated strategies to reduce stress and burnout, such as the use of psychological or sensory-emotional techniques, group discussions, mindfulness or compassion-based programs, auricular acupressure, and cannabidiol treatment. These studies reported short-term improvements; however, small cohorts, high attrition rates, lack of sample diversity, or the need for pharmacological therapy have limited their utility, highlighting the need for rigorously tested interventions for burnout, anxiety, and stress.1

 Transcendental Meditation (TM) is an evidence-based meditation practice in which individuals silently recite a single mantra (a sound that lacks meaning) without concentration or contemplation. Studies on TM practitioners have revealed patterns of increased parasympathetic response leading to attenuation of the stress response. Clinical trials have demonstrated that the efficacy of TM for the reduction of stress and burnout among teachers3 and emergency department clinicians4. The practice of TM has been found to reduce post-traumatic stress disorder symptoms in veterans 5,6, which might be particularly relevant because recent reports of HCW burnout suggest a similarity to the experiences of combat veterans.7

 Aims/Objectives: The primary aim of the study is to evaluate whether engaging in TM intervention is feasible and acceptable for HCPs. The secondary aims are to assess change in measures of wellbeing, burnout, anxiety and stress at baseline, at 1-month and at 3-month follow-up.

 Methodology: This is an open-label, prospective, randomized, controlled, single-centered study based in a tertiary care hospital in Rural India. Healthcare professionals will be randomized using stratified randomization based on age (<40 years vs ≥40 years), gender (male vs female) and medical profession (doctors vs nurses) into study groups A & B. Group A will receive Transcendental Meditation and group B will act as control who will have access to wellness resources. The study will assess whether engaging in TM intervention is feasible and acceptable for HCPs measured by self-report questionnaires. Validated and reliable outcome measures of wellbeing, burnout, anxiety, and stress will be collected at baseline and at 3-month follow-up.

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
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Fulltime healthcare providers, medical doctors or nurses involved in active patient care or direct hospital administration.
  • 18 years or older
  • Willing to complete both baseline and post-testing
  • In the active treatment group, willing to dedicate the time required to learn the TM technique and practicing it twice daily for 20 minutes each time.

排除标准

  • Already instructed in the TM technique
  • Currently unstable psychiatric symptoms as demonstrated by self-report, medical chart, or psychiatric hospitalizations in the past six months
  • Use of antipsychotic or β blocker medications
  • current suicidal ideation.

结局指标

主要结局

Feasibility and acceptability of TM

时间窗: Baseline and 3-month follow up

次要结局

  • 1. Perceived Stress Scale-4 (PSS-4)(2. Generalised Anxiety Disorder Scale (GAD-7))

研究者

发起方
SMSIMSR, Sri Sathya Sai University for Human Excellence
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Rajesh Naithani

Sri Sathya Sai University for Human Excellence

研究点 (1)

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