Hypnosis in Interventional Electrophysiology (PAINLESS)
Hypnosis Contribution to Interventional Electrophysiology Performed Under Local Anesthesia and Morphine Titration Study PAINLESS : Does Hypnosis Reduce Pain in Electrophysiology Procedures ?
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.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Poitiers、法国
- CHU De Poitiers
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Over 18 years old
- Surgery ablation of atrial flutter
- Agreement to participate of the study
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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安慰剂比较：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.
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Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones
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实验性的：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:
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Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Global pain self-assessment during the procedure
大体时间：Collected 45 min after the procedure
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Assessed with visual analogue pain scale
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Collected 45 min after the procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Anxiety during the procedure
大体时间：Collected after the procedure
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Visual analog scale self-assessment
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Collected after the procedure
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Morphine consumption
大体时间：Collected after the procedure
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milligram
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Collected after the procedure
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Patient sedation evaluation
大体时间：Collected after the procedure
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numerical rating scale; Externally assessed by the electrophysiologist
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Collected after the procedure
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Pain assessed prospectively during the procedure;
大体时间：Evaluated every 5 minutes during the procedure;
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Numerical rating scale score
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Evaluated every 5 minutes during the procedure;
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Placebo的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)完全的造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Luye Pharma Group Ltd.尚未招聘
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Mila (bMotion Technologies)完全的