NCT04129333已完成不适用
HYPIC Hypnosis for Procedural Pain in the Intensive Care Unit
Rennes University Hospital4 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年12月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Pain assessment
研究概览
简要总结
Procedural pain in resuscitation is common in the conscious patient. However, analgesia and sedation may be impossible because of the acute pathology leading to resuscitation, comorbidities or the urgency of the invasive procedure. In addition, the use of analgesics and sedatives is responsible for adverse effects. In this context, hypnosis appears to be an additional analgesic tool that would reduce the consumption of analgesics and sedatives and thus reduce their side effects.
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 (Outcomes Assessor)
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
- •Major patient admitted to intensive care
- •Glasgow score = 15
- •Necessity during the stay of making an invasive gesture among:
- •Thoracic drainage
- •Placement of a central venous catheter or a Swan-Ganz catheter
- •Establishment of a dialysis catheter
- •Introduction of an invasive arterial catheter
- •Patient giving free, informed and written consent
- •Patient affiliated to a social security scheme
- •Non inclusion Criteria:
- •Procedure to be carried out in extreme urgency
- •Confusional state making hypnosis impossible, evaluated by CAM-ICU (Confusion Assessment Method for the Intensive Care Unit)
- •Decompensated psychiatric illness
- •Patient sedated or intravenous analgesia continued at the time of the procedure
- •Patient intubated
- •Patient with a contraindication to sedation or analgesia at the time of the procedure
- •Patient receiving topical anesthesia before the start of the procedure
- •Major person subject to legal protection (court bail, curator, guardianship) or deprived of liberty
- •Patient already included in the study during the completion of a previous invasive procedure
- •Patient participating in a research involving an interventional human person (category 1) on an analgesic / sedative drug
排除标准
- 未提供
结局指标
主要结局
Pain assessment
时间窗: Immediately after the end of the invasive procedure (Hour 0)
Oral assessment scale (0 : no pain - 10 : maximal pain)
次要结局
- Morphine equivalent dose(Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1))
- Comfort scale(Immediately after the end of the invasive procedure (H0) and the first hour after the end of the procedure (H1))
- Pain assessment(The first hour after the end of the procedure (Hour 1))
- Duration(Immediately after the end of the invasive procedure (Hour 0))
- Number of attempts and failures of the procedure(The first hour after the end of the procedure (Hour 1))
- Sedatives dose(Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1))
- Local Anesthesia dose(Immediately after the end of the invasive procedure (Hour 0))
- Anxiety(Immediately after the end of the invasive procedure (Hour 0) and the first hour after the end of the procedure (Hour 1))
- Adverse events(The first hour after the end of the procedure (Hour 1))
- Length of stay in intensive care unit(Day 28)
- Nurse stress(Immediately after the end of the invasive procedure (Hour 0))
研究者
研究点 (4)
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