Effect of Intra-procedure Music on Anxiety for Interventional Radiology Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- State-Trait Anxiety Inventory (STAI) score
研究概览
简要总结
The purpose of this study is to examine the effects of intra-procedure music intervention on procedural anxiety, physiological stress and sedation requirements in patients undergoing moderate sedation procedures. Study participants will be randomly assigned into two groups: 1. Control - standard care without music intervention. 2. Intervention - standard of care plus music intervention. The State-Trait Anxiety Inventory questionnaire will be provided pre, intra and post procedure to all subjects in addition to an exit survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult (>18 years old) patients
- •Scheduled for moderate sedation procedures in the Interventional Radiology department at Tisch Hospital, NYU Langone Health in New York, New York
- •Able to read and write in English at a sixth grade level (STAI is written at sixth grade comprehension level)
排除标准
- •Not a moderate sedation candidate (hemodynamically unfit, not optimized for procedure, pregnant)
结局指标
主要结局
State-Trait Anxiety Inventory (STAI) score
时间窗: Up to 12 months
To examine the effects of intra-procedure music on subjects' anxiety surrounding (pre, during, post) procedures in interventional radiology. Anxiety will be measured by a validated questionnaire called the State-Trait Anxiety Inventory (STAI)
次要结局
- Heart rate(Up to 12 months)
- Amount of sedation required(Up to 12 months)
- Respiration rate(Up to 12 months)
- Blood pressure(Up to 12 months)
- Pain score(Up to 12 months)
- RASS score(Up to 12 months)