Hypnosis Contribution to Interventional Electrophysiology Performed Under Local Anesthesia and Morphine Titration Study PAINLESS : Does Hypnosis Reduce Pain in Electrophysiology Procedures ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Global pain self-assessment during the procedure
研究概览
简要总结
Hypnosis has already shown to decrease pain and anxiety in different surgical specialities. Nevertheless, its input has never been studied in cardiology. This research is a prospective, monocentric, controlled and randomized study.
Patients over 18 years old and hospitalized for atrial flutter ablation may be included and randomized into one of the arms: placebo or hypnosis.
Global pain will be assessed by a visual analogue pain scale. Anxiety, morphine consumption, and patient sedation will also be assessed.
The aim of this study is to improve the care given to patient undergoing atrial flutter ablation.
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 (Participant)
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
- •Over 18 years old
- •Surgery ablation of atrial flutter
- •Agreement to participate of the study
排除标准
- •Person who does not speak French or deaf
- •Chronic pain with the visual analogue scale > 5
- •Psychiatric pathology
- •Contraindication to paracetamol, lidocaine, morphine
- •Pregnant women, or breast-feeding women or without effective contraception
研究组 & 干预措施
Placebo
Placebo will be the suggestion of self-relaxation methods (for example, "try to relax" ,"try to think of pleasant moment ") and the diffusion of "white noise" during surgery.
干预措施: Placebo (Other)
Hypnosis
Hypnosis will be associated with the usual anesthesia. Hypnosis is a temporary modification of consciousness technique based on suggestion.
It is divided into three phases:
- induction: attention of the patient fixed on an object or a part of the body,
- the dissociation where the patient cuts off auditory, visual and tactile perceptions,
- and finally the opening towards a hypnotic experience thanks to the imaginary.
干预措施: Hypnosis (Other)
结局指标
主要结局
Global pain self-assessment during the procedure
时间窗: Collected 45 min after the procedure
Assessed with visual analogue pain scale
次要结局
- Pain assessed prospectively during the procedure;(Evaluated every 5 minutes during the procedure;)
- Anxiety during the procedure(Collected after the procedure)
- Morphine consumption(Collected after the procedure)
- Patient sedation evaluation(Collected after the procedure)