Hypnosis Efficacy for the Prevention of Anxiety During a Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- State Anxiety
研究概览
简要总结
The purpose of this study is to confirm the utility for hypnosis in the coronary angiographic examination. The technique would be an alternative to prevent the consumption of anesthesic drugs.
详细描述
The coronary angiography is a medical imaging acquisition used in cardiology to highlight the coronary arteries after a coronary disease suspicion. According to an expert consensus it is performed under local anesthesia. Indeed the examination is quite painless, apart from the initial arterial puncture. Moreover, any patient chest pain must be detected during the examination to locate the guilty coronary injury. This is not possible with a patient under general anesthesia.
But, no general anesthesia may be a source of anxiety for patients, and the technique can be painful at several times: during the puncture, the exploration of probe into the winding, spastic or over-calcified arteries, or even during the dilation by the balloon swelling which obstructs downstream the artery.
The efficiency evaluation of the hypnosis made by INSERM in 2015 concludes that "the use of hypnosis during a surgical practice or during a medical or a interventional radiological act allows to reduce the consumption of sedative drugs and/or pain medication preoperatively".
The study hypothesis, is that hypnosis can contribute to a decreasing of anxiety and the pain for patients undergoing coronary angiography, and even a decreasing of complications due to a better control of hemodynamic (heart rate and blood pressure).
It could entail a better comfort for operator during the coronary angiography.
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
- 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
- •coronary angiography scheduled with or without stenting
- •registered with a social security scheme
- •people informed clearly by the investigator
排除标准
- •coronary angiography already performed
- •not well french speaking and understanding
- •with functional disabilities (mental disorder, ...)
- •known background of schizophrenia
- •deaf or hard of hearing
- •patient under legally protection
研究组 & 干预措施
Control group
No hypnosis session before the coronary angiography
Hypnotised group
Hypnosis session before the coronary angiography
干预措施: Hypnosis session (Behavioral)
结局指标
主要结局
State Anxiety
时间窗: 1 day
Spielberger State-Trait Anxiety Inventory (STAI):
次要结局
- Heart rate(1 day)
- Blood pressure(1 day)
- Pain(1 day)
- Comfort for the operator of the angiography(1 day)
- Major complications(1 day)
- dose of sedative drugs(1 day)