FEAT: Functional Change in Endothelium After Cardiac cAtheterization, With and Without Music Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- change in reactive hyperemia index measured by peripheral arterial tonometry
研究概览
简要总结
The purpose of this study is to determine the effect of music therapy before, during, and after cardiac catheterization is associated on (a) change in reactive hyperemia index measured before and after catheterization using peripheral arterial tonometry and (b) patient stress and discomfort measured by a questionnaire, as compared to the standard of care (no music during cardiac catheterization).
The hypothesis of the study is that music therapy during cardiac catheterization will be associated with more favorable change in reactive hyperemia and higher patient satisfaction compared to no music playback.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Referred for clinically-indicated cardiac catheterization
排除标准
- •Refusal or inability to provide signed informed consent
- •Significant hearing loss
研究组 & 干预措施
Music therapy
The music played will be by MusiCure, by Niels Eje (slow, relaxing music designed for therapeutic use), and will be played from an audio pillow beneath the patient's head.
干预措施: Music therapy (Other)
No music therapy
结局指标
主要结局
change in reactive hyperemia index measured by peripheral arterial tonometry
时间窗: PAT will be performed within 2 hours before cardiac catheterizaiton and repeated within 2 hours after the end of cardiac catheterization
次要结局
- Stress and anxiety questionnaire(questionnaire will be completed within 2 hours after the end of cardiac catheterization)
研究者
Emmanouil Brilakis
Director, Cardiac Catheterization Laboratories
North Texas Veterans Healthcare System