Effect of Language and Confusion on Pain During Peripheral Intravenous
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 294
- 试验地点
- 6
- 主要终点
- numerical rating scale for pain from 0 to 10
研究概览
简要总结
The purpose of this study is to compare three communications during peripheral intravenous catheterization and measure pain patient: one hypnotic, confusion (HYPNOSIS), an other with negative connotation (NOCEBO) and at least with neutral connotation (NEUTRAL).
详细描述
Clinicians used to warn patients of pain or discomfort before potentially painful procedures like peripherical intravenous catheterization (PIVC). However, suggestions for negative perceptual experiences causes more pain and anxiety. During This does not improve at all the real-life experience of the act. On the contrary, the use of gentler words improves pain perception and subjective patient experience. Furthermore, hypnosis has been demonstrated as efficient and the pain perception seems to be modulate by hypnotic suggestions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •at least 18 years
- •peripheral intravenous catheterization of 20 G on the dorsal face of the hand before a planned surgery
- •written and informed patient consent
- •Non inclusion Criteria:
- •patient unable to communicate in french
- •difficult vein access characteristics
- •premedication
- •pregnant, breast-feeding woman
- •patient subject of legal protection
排除标准
- •failed of the first attempt of peripheral intravenous catheterization
研究组 & 干预措施
HYPNOSIS
hypnotic communication, confusion procedure during peripheral intravenous catheterization
干预措施: Hypnotic communication (Other)
HYPNOSIS
hypnotic communication, confusion procedure during peripheral intravenous catheterization
干预措施: peripheral intravenous catheterization (Other)
NOCEBO
negative connotation communication during peripheral intravenous catheterization
干预措施: negative connotation communication (Other)
NOCEBO
negative connotation communication during peripheral intravenous catheterization
干预措施: peripheral intravenous catheterization (Other)
NEUTRAL
neutral connotation communication during peripheral intravenous catheterization
干预措施: neutral connotation communication (Other)
NEUTRAL
neutral connotation communication during peripheral intravenous catheterization
干预措施: peripheral intravenous catheterization (Other)
结局指标
主要结局
numerical rating scale for pain from 0 to 10
时间窗: data collected within 3 min after the end of peripheral intravenous catheterization procedure
self-evaluation of pain catheterization
次要结局
- evolution of numerical rating scale for comfort from 0 to 10(data collected just before and within 3 min after peripheral intravenous catheterization procedure)
- presence of unprompted vocalization by word(s) or sound(s)(data collected within 3 min after the end of peripheral intravenous catheterization procedure)
- presence of spontaneous patient arm withdrawal(data collected within 3 min after the end of peripheral intravenous catheterization procedure)
- evolution of numerical rating scale for anxiety from 0 to 10(data collected just before and within 3 min after peripheral intravenous catheterization procedure)