Intraoperative Music Therapy in TAVR Patients: A Randomized Controlled Trial to Reduce Anxiety and Improve Patient Experience
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the effect of intraoperative music on patient anxiety and comfort during transcatheter aortic valve replacement (TAVR) procedures.
详细描述
This study is exploring whether listening to music during a minimally invasive heart valve procedure called transcatheter aortic valve replacement (TAVR) can help reduce patient anxiety. TAVR is often done with light sedation, so patients may be awake and aware during parts of the procedure, which can sometimes feel stressful. In this study, patients will be randomly assigned to either listen to relaxing music through headphones during the procedure or to wear headphones without music.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The surgeon will also be blinded.
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
- •Scheduled to undergo elective transfemoral TAVR under MAC (Monitored Anesthesia Care) at Rhode Island Hospital
- •Able to answer questions about anxiety
排除标准
- •Transfemoral TAVR procedures requiring general anesthesia
- •Emergent TAVR procedures
- •Significant hearing impairment that would preclude ability to hear music via headphones
- •Documented severe claustrophobia or inability to tolerate headphones
- •Inability to complete questionnaires
- •Inability or unwillingness to provide informed consent
研究组 & 干预措施
Control Group (No music)
Open ear headphones will be placed on the patient in the operating room and will remain in place for a minimum of 45 minutes. Headphones will be removed at the conclusion of surgery when standard monitoring is discontinued.
干预措施: Control Group (no music) (Behavioral)
Music Group
Open ear headphones will be placed on the patient in the operating room and will remain in place for a minimum of 45 minutes. Headphones will be removed at the conclusion of surgery when standard monitoring is discontinued.
干预措施: Music (Behavioral)
研究者
Shyamal Asher, MD
Principal Investigator
Rhode Island Hospital