Pilot Study of the ANI (Analgesia Nociception Index) Validity on the Nociception Assessment in Healthy Volunteers in State of Hypnosis, Compared to Painful Numerical Verbal Scale (EVN).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- EVN value of pain intensity versus average value of the ANI
研究概览
简要总结
Healthy subjects should assess pain on a numerical scale (EN), during painful skin stimuli of variable intensity delivered by a CO2 laser used at the power of 0.3 W, known for its safety. ANI (Analgesia Nociception Index) will be raised simultaneously. This sequence will be made on subjects at rest and in a state of hypnosis using the technique of "remembering a pleasant memory" and the ideo-sensory technique of "protective glove".
The average value of the ANI will be compared to the value of the EVN of pain intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Knowledge of the state of hypnosis
- •Healthy volunteers
- •Capable adults
- •Free and informed consent
排除标准
- •Heart diseases
- •Medication affecting the heart rate
- •Medication affecting the skin sensitivity
研究组 & 干预措施
painful stimuli
No drug and no placebo will be used in this study. The study participants will only rate their pain on a numerical scale (EN) following cutaneous painful stimulation (6 for each phase) of variable intensity, delivered by a CO2 laser. ANI (Analgesia Nociception Index) will be raised simultaneously by the ANI monitor. This sequence will be performed on subjects at rest and in a state of hypnosis by the technique of "remembering a pleasant memory" and the ideo-sensory technique of "protective glove".
干预措施: CO2 laser and ANI monitor (Device)
结局指标
主要结局
EVN value of pain intensity versus average value of the ANI
时间窗: ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation
ANI value (0 to 100, without unit of measure) recorded continuously for 60 seconds after the painful stimulation compared to the EVN value of the pain intensity, from zero to ten (numerical verval scale), and this for each of 6 painful stimuli intensities of each three consecutive phases of the study.
次要结局
- EVN value of the arduousness of pain perception versus ANI value(ANI average value : measured continuously for 60 seconds after the painful stimulation. EVN value : raised a few seconds after the painful stimulation)