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临床试验/CTRI/2024/12/077573
CTRI/2024/12/077573尚未招募3 期

Effect of MSRT (Mind Sound Resonance Technique) and Yoga Nidra on Heart Rate Variability and Oxidative Stress Markers in Mixed Depressive Anxiety Disorder (MDAD) - A Randomized Control Clinical Trial

Institute of Medical Sciences Banaras Hindu University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年12月11日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
120
试验地点
1
主要终点
to compare the impact of MSRT and Yoga Nidra on Anxiety, And Depression in Mixed Depressive Anxiety disorder.

研究概览

简要总结

Mixed depressive and anxiety disorder (MDAD) is characterized by symptoms of both anxiety and depression more days than not for a period of two weeks or more.Yoga is a powerful tool for managing anxiety and depression, with significant positive effects on HRV by promoting a balanced autonomic nervous system, enhancing parasympathetic activity, and reducing stress, yoga can improve overall mental health and well-being.

High HRV is generally associated with good health and a well-functioning stress response system, while low HRV is linked to stress, anxiety, depression, and other health issues. Yoga can play a significant role in managing anxiety and depression by positively influencing HRV.

Yoga mantras and prayers have been found beneficial for many physiological and psychological functions of the body.(Bernardi et al., 2001). A study conducted by (Amin et al., 2016) found Om chanting has beneficial effects on depression, anxiety and stress scores.

another study validates the effectiveness of Om chanting and Yoga Nidra in reducing depression, anxiety, stress and improving sleep quality and autonomic functions in hypertensive patients.(Rajagopalan et al., 2023a)

This study has the potential to enhance evidence-based interventions for individuals experiencing depression and anxiety. We will investigate how MSRT and Yoga Nidra affect psychophysiological factors alongside biochemical measurements.

Additionally, there is no report of an earlier comparative study on the efficacy of MSRT and Yoga Nidra on Anxiety and Depression so far. Although, many good RCT studies on Depression and Anxiety have been done where Om chanting and Yoga Nidra was reported to be more efficacious.

So, considering all, the proposed study admits to correcting the limitations of previous studies by evaluating the effect of Yoga Nidra and MSRT on Heart Rate Variability,Oxidative Stress Markers, Depression and Anxiety.

AIM OF THE STUDY:

The present study aims to assess the effects of MSRT (Mind Sound Resonance Technique – A Yoga-Based Relaxation Technique) and Yoga Nidra on Heart Rate Variability, Oxidative Stress, Anxiety and Depression and compare with control group.

Objective of the study: -

i        to evaluate the effect of MSRT and Yoga Nidra on Heart Rate Variability in patients with Mixed Depressive Anxiety disorder.

ii  to evaluate the impact of MSRT and Yoga Nidra on biochemical and inflammatory markers related to oxidative stress among the subject of Mixed Depressive Anxiety disorder.

iii    to compare the impact of MSRT and Yoga Nidra on Anxiety, And Depression in Mixed Depressive Anxiety disorder.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Eighteen (20) to sixty (60) years of age.
  • Patients to have met the ICD 11 diagnostic criteria for MDAD (will be assessed by the referring clinician).
  • Sex – male and female.
  • Patients who will be able to understand the instruction in Hindi or English language.
  • Willingness to participate in the trial.

排除标准

  • Exclusion criteria (Hypertension, renal, endocrine, cardiovascular and respiratory disorders are known to affect autonomic system of the body in many ways; that’s why these were chosen as exclusion criteria).
  • Patients with hypertension Any history of blood transfusion within 3 months.
  • Patients with renal and endocrine disorders Patients with cardiovascular disorders Patients with respiratory disorders or any other chronic disease.
  • Sleeping pills (masking of intervention effects) Cannabis within 30 d (masking intervention effects) Smoke cigarettes and alcoholism (interference with relaxation and may influence cognitive functions and sensory and motor variables).

结局指标

主要结局

to compare the impact of MSRT and Yoga Nidra on Anxiety, And Depression in Mixed Depressive Anxiety disorder.

时间窗: outcome will be assessed at baseline, 6 weeks and 12 weeks

次要结局

  • to evaluate the impact of MSRT(and Yoga Nidra on biochemical & inflammatory markers related to oxidative stress among the subject of Mixed Depressive Anxiety disorder.)
  • to evaluate the effect of MSRT & Yoga Nidra on Heart Rate Variability in patients with Mixed Depressive Anxiety disorder.(outcome will be assessed at baseline, 6 weeks & 12 weeks)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Mayank Vishwakarma

Institute of Medical Sciences, Banaras Hindu University, Uttar Pradesh-221005.

研究点 (1)

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