CTRI/2024/11/077431尚未招募2/3 期
Efficacy Of Yoga Nidra And Nadi Sodhana Pranayama In The Management Of Anidra- A Randomised Comparative Clinical Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- This study will provide information about efficacy of Yoga nidra and Nadi sodhana pranayama in the improvement AIS & quality of sleep.
研究概览
简要总结
Research Question: Is there a difference between Yoga Nidra and Nadi Shodhana Pranayama on the Athens Insomnia Scale (AIS) in patients with Anidra?
Hypotheses
- Null Hypothesis (H0): No difference exists between Yoga Nidra and Nadi Shodhana Pranayama in improving AIS in Anidra patients.
- Alternate Hypothesis (H1): There is a difference between Yoga Nidra and Nadi Shodhana Pranayama in improving AIS in Anidra patients.
Introduction
- Sleep (Nidra) is one of the three pillars of life in Ayurveda, vital for maintaining health.
- Anidra (insomnia) is a psychosomatic condition caused by stress, poor lifestyle, and other factors, leading to impaired quality of life.
- Ayurveda describes imbalances in Tarpaka Kapha, Sadhaka Pitta, and Prana Vayu as the cause of Anidra.
- Yoga Nidra is a meditative technique offering mental and physiological relaxation, while Nadi Shodhana Pranayama (a breathing practice) improves stress levels, emotional stability, and sleep.
Need for the Study
- Insomnia affects a large portion of the population and is often managed with sedative drugs, which can have side effects.
- Non-pharmacological, natural interventions like Yoga Nidra and Nadi Shodhana provide a safer and sustainable approach to managing insomnia.
Objective
- Primary: Compare the effects of Yoga Nidra and Nadi Shodhana Pranayama on improving AIS.
- Secondary: Enhance the quality of sleep and life in Anidra patients.
Literature Review
- Yoga Nidra improves sleep patterns, reduces stress, and enhances physiological rest.
- Nadi Shodhana Pranayama promotes emotional stability, reduces anxiety, and calms the nervous system.
- Previous research supports the effectiveness of both interventions in improving sleep quality and mental health.
Study Design
- Type: Clinical, prospective study.
- Sample Size: 36 participants per group (72 total).
- Groups:
- Group A: Yoga Nidra (30 minutes daily at 10 PM).
- Group B: Nadi Shodhana Pranayama (15 minutes, twice daily at 8 AM and 8 PM).
- Duration: 30 days with a follow-up after 15 days.
Outcome Measures
- Primary Outcome: Change in Athens Insomnia Scale (AIS) scores.
- Secondary Outcome: Improvement in sleep quality and overall quality of life.
Data Analysis
- Categorical variables: Summarized with frequency and percentages.
- Quantitative variables: Analyzed using mean, SD, or non-parametric methods as appropriate.
- Tests: Paired t-test, Wilcoxon rank test, and unpaired t-test.
- Software: SPSS and EZR.
Techniques and Interventions
- Yoga Nidra: Guided meditation based on a recorded script, including body relaxation, breath awareness, and visualization.
- Nadi Shodhana Pranayama: Alternate nostril breathing performed in a structured manner.
Expected Outcomes
- Insight into the comparative effectiveness of Yoga Nidra and Nadi Shodhana Pranayama in managing Anidra.
- Recommendations for safer, non-invasive treatments for insomnia.
4o
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients of the age group between 21 to 50 years irrespective of gender, caste, religion, etc.
- •2.Patients having different types of disturbed sleep patterns e.g. sleep onset insomnia, sleep maintenance insomnia, and nocturnal awakening.
- •3.Patients with the chronicity of Anidra of atleast 3 months.
排除标准
- •1.Patients on hypnotic medicine or other drugs known to cause drowsiness.
- •2.Patients suffering from any chronic metabolic disorder.
- •3.Taking treatment for any psychiatric issues.
- •4.Subjects on systemic or oral steroids.
- •5.Patients with alcohol or drug dependency.
- •6.patients suffering from fatal familial insomnia.
结局指标
主要结局
This study will provide information about efficacy of Yoga nidra and Nadi sodhana pranayama in the improvement AIS & quality of sleep.
时间窗: after 30 days it will be assessed
次要结局
未报告次要终点
研究者
Dr Niral Priyadarshi
All India Institute of Ayurveda
研究点 (1)
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