Comparison of the Efficacy of Hypnosis on Pain and Anxiety Versus Standard Care During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Self-reported pain during the lumbar puncture
研究概览
简要总结
Lumbar puncture is a diagnostic procedure performed as part of the etiological assessment of cognitive disorders. Despite good tolerance and very rare complications, lumbar puncture is still perceived as being painful or anxiety-provoking by patients. Hypnosis could improve pain and anxiety when performing lumbar puncture.
详细描述
Lumbar puncture is an invasive procedure potentially inducing pain and anxiety indicated in elderly patients for cognitive assessment. Indeed, the measure of amyloid biomarkers and tau in the cerebrospinal fluid is useful in the etiological diagnosis of cognitive disorders. With the ageing of the population and the increase incidence of cognitive disorders, this diagnostic procedure will be more and more frequent. Many studies have shown the efficiency of hypnosis during invasive procedure, especially in young children. The absence of side-effect is a major asset in elderly patients at high iatrogenic risk. It represents an interesting alternative to anxiolytic or sedative treatments. Nevertheless, its effectiveness in the elderly during lumbar puncture remains to be demonstrated. Investigators hypothesized that hypnosis may decrease pain and anxiety during lumbar puncture associated to setting comfort situation (relational care, music, transcutaneous anesthesia).
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 (Investigator)
盲法说明
the investigator will blindly collect the subject's self-rated pain and anxiety scales.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 70 years old
- •Indication for a lumbar puncture for etiological diagnosis of cognitive impairment
- •Understanding French Language
- •Written and informed consent for this study signed by the patient
- •Affiliated to Health Insurance
排除标准
- •MMS< 17 or cognitive impairment not allowing informed consent
- •Contraindication to lumbar puncture
- •Refusal to sign the written and informed consent
- •Patient deprived of freedom by court or administrative order
结局指标
主要结局
Self-reported pain during the lumbar puncture
时间窗: 1 day
Pain is assessed by visual analogue scale, a self-reported pain rating scale (0 "no pain" to 10 "worst pain")
次要结局
- Pain assessed by the physician during the lumbar puncture using Algoplus© score(1 day)
- Assessment of anxiety during the lumbar puncture according a visual analogue scale(1 day)
- Assessment of anxiety during the lumbar puncture according a numeric scale(1 day)
- Assessment of anxiety during the lumbar puncture by monitoring the heart rate(1 day)
- Assessment of anxiety during the lumbar punctureby monitoring the Galvanic Skin Response(1 day)