Effectiveness Of Ananda Bhairavi Raga For Claustrophobic Patients Undergoing MRI: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Generalized Anxiety Disorder-7 (GAD-7) scale
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of Raga Ananda Bhairavi, an Indian classical raga, in reducing anxiety and claustrophobic symptoms among patients undergoing MRI. A total of 100 participants aged 18–65 years will be randomly assigned to either the intervention group, which receives music therapy using Raga Ananda Bhairavi during the MRI scan along with deep breathing exercises, or the control group, which practices deep breathing only without music. Anxiety levels will be measured using the Generalized Anxiety Disorder-7 (GAD-7) scale, claustrophobic symptoms with the Claustrophobia Questionnaire (CLQ), and subjective experience through the Visual Analogue Scale (VAS), both pre- and post-scan. Additional qualitative feedback will be collected via open-ended questions. The study aims to explore a safe, cost-effective, and culturally relevant non-pharmacological intervention to improve patient comfort, reduce anxiety-related scan terminations, and enhance the overall MRI experience.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants may need to fall within a certain age range (e.g., 18-65 years old) for factors related to age and emotional regulation.
- •Patients must be able to understand the study and the informed consent to the participant will be given.
- •Participants must have their MRI procedure eligibility confirmed by the Department of Radiodiagnosis as patients must be eligible to undergo an MRI scan (e.g., no metal implants, pacemakers, or other contraindications).
- •Only participants undergoing MRI scans with the head end positioned inside the MRI machine will be considered for the study.
- •Any score or response from the pre-test anxiety and stress questionnaire will be considered for analysis, ensuring inclusion regardless of initial anxiety or stress levels.
- •Participants should not have taken sedatives or other medications that might alter the results of the anxiety or claustrophobia response during the MRI.
排除标准
- •Individuals with severe anxiety disorders (other than claustrophobia), mood disorders, psychosis, or intellectual disabilities might be excluded due to potential confounding factors.
- •Individuals who do not consent to participate or are unable to cooperate during the procedure will be excluded.
- •Pediatric patients and the patient who are unconscious are excluded.
- •Patients with Acute window stroke, and uncontrolled chronic illnesses, particularly those that might contraindicate MRI (e.g., severe cardiovascular or neurological conditions), would typically be excluded.
- •Individuals who are unable to hear the music (if it is auditory music therapy) would likely be excluded, as they would not be able to experience the intervention as intended.
- •Participants who have previously undergone an MRI scan or those scheduled for repeated scans will be excluded from the study.
结局指标
主要结局
Generalized Anxiety Disorder-7 (GAD-7) scale
时间窗: Primary Outcome: | Change in anxiety levels assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale. | Time Points: | Baseline (immediately before MRI scan) | Post-intervention (immediately after MRI scan) | Description | This outcome evaluates the effectiveness of Raga Ananda Bhairavi in reducing pre-procedural anxiety among claustrophobic patients by comparing anxiety scores before and after the MRI procedure.
次要结局
- Claustrophobia Questionnaire (CLQ)(Outcome Name:)
- Visual Analogue Scale (VAS)(Outcome Name)
- open-ended questions post-MRI(Outcome Name:)
研究者
Gana Pilinja
Nitte Institute of Physiotherapy