The Effect of Raga based Music Therapy and Cognitive Behavioral Therapy on Sleep Quality, Anxiety level and Quality of Life among patients with Moderate to Severe Anxiety induced Insomnia - A Randomized control study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Improvement in Sleep quality and reduction in Anxiety level of patients experiencing Insomnia due to Anxiety.
研究概览
简要总结
Title: The Effect of Raga-Based Music Therapy and Cognitive Behavioral Therapy on Sleep Quality, Anxiety Levels, and Quality of Life Among Patients with Moderate to Severe Anxiety-Induced Insomnia “ A Randomized Control Study.
Background and Objective: Anxiety-induced insomnia significantly affects sleep quality, mental health, and overall quality of life. Cognitive Behavioral Therapy for Insomnia (CBT-I) is a proven therapeutic intervention, while raga-based music therapy, rooted in Indian classical music, is emerging as a complementary approach. This study aims to evaluate the combined effects of these interventions on sleep quality, anxiety levels, and quality of life in patients with moderate to severe anxiety-induced insomnia.
Methodology: A randomized controlled trial (RCT) design will be employed. Patients meeting the inclusion criteria will be randomly assigned to two groups: experimental and control group. The Experimental group takes part in Raga-Music therapy and Cognitive-Behavioral therapy (MT + CBT) while the control group will receive routine medical care with psychotropic drugs.
Outcome measures will include sleep quality (assessed using Pittsburgh Sleep Quality Index), anxiety levels (measured using the Hamilton Anxiety Rating Scale), and quality of life (evaluated through WHOQOL-BREF). Assessments will occur at baseline and post-intervention phases.
This trial seeks to establish raga-based music therapy as an effective adjunctive treatment alongside CBT-I for managing anxiety-induced insomnia.
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 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients experiencing insomnia due to anxiety disorder and who are on psychotropics.
- •Patients diagnosed with moderate and severe symptoms of Anxiety and Insomnia.
排除标准
- •Patients with psychosis, substance abuse, adjustment disorders, and other psychiatric disorders will be excluded from the study.
- •Patients with major medical or neurological co-existing conditions.
- •Patients who are not interested in listening to raga-based instrument music.
- •Patients with hearing deficit.
- •Patients who are not willing to participate in the study will be excluded.
结局指标
主要结局
Improvement in Sleep quality and reduction in Anxiety level of patients experiencing Insomnia due to Anxiety.
时间窗: Baseline Assessment (Pre-test), Intervention Phase and Follow-up Assessment (Post-test) will be done in the 10th week.
次要结局
- Improvement in Quality of life(Baseline Assessment (Pre-test), Intervention Phase and Follow-up Assessment (Post-test) will be done in the 10th week.)
研究者
ELAKIYA S
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University)