Utility of Hypnosis for Transesophageal Echocardiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Level of patient comfort
研究概览
简要总结
The purpose of this study is to determine the additive value of hypnosis to improve patient comfort during transesophageal echocardiography (TEE).
详细描述
TEE is a widely used diagnostic test in cardiovascular medicine. However, the test may be a source of discomfort to the patient. Patient intolerance of the echocardiography probe limits the duration of the procedure and therefore its diagnostic success. Current strategies to reduce patient discomfort involve global anesthesia, which carries its own side effects and risks of adverse events. Hypnosis may reduce patient discomfort without impairing alertness. The main goal of this study is to determine the additive value of hypnosis to improve patient comfort during TEE.
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
- Single (Investigator)
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
- •Patient with indication for a Transesophageal Echo (TEE)
- •Patient competent to provide written informed consent
排除标准
- •Patient not subscribed to French Social Security System
- •Patient non-French speaking
- •Age < 18 years
- •Follow-up not possible
- •patient declared non competent to give informed consent for the study
- •History of severe personality disorder
- •Patient with a psychiatric treatment started 30 days before the exam
- •Patient pregnant or breast-feeding
- •Emergency TEE
- •Other indication for general anesthesia
研究组 & 干预措施
Conventional procedure
Local anaesthesia (Lidocaïne)
干预措施: Conventional procedure (Procedure)
Conventional procedure + Hypnosis
Local anaesthesia (Lidocaïne) and Hypnosis
干预措施: Conventional procedure + Hypnosis (Procedure)
结局指标
主要结局
Level of patient comfort
时间窗: at Day 0
Visual Analogic Scale
次要结局
- Quality of the procedure as assessed by the operator(at Day 0)
- Rate of procedure failure or non-diagnostic study(at Day 0)
- Duration of the procedure(at Day 0)