NCT05092906已完成不适用
Randomized Controlled Study Evaluating The Contribution of a Hypnosis Intervention During a Lumbar Puncture in the Neurology Department.
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2021年11月9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
- 74
- 试验地点
- 2
- 主要终点
- Maximum pain felt during LP
研究概览
简要总结
The purpose of this study is to assess the effect of hypnosis, as add on therapy, on patients requiring a lumbar puncture (LP) as part of their medical management.
详细描述
This study will follow the zelen's methodology randomization. It is an add-on study design.
- The study will be presented to patients as an assessment of their comfort during the LP. The intervention group is not presented to the patient.
- Patients are asked to sign the consent of the standard of care group.
- Randomization into two equally sized groups:
- Intervention arm : LP with complementary hypnoanalgesia
- Control arm : LP without complementary hypnoanalgesia
- Patients who have been randomized into the control group, will have LP according to the standard of care.
Patients who have been randomized into the hypnoanalgesic group will be informed about the hypnoanalgesia intervention and then asked to sign the consent of the hypnosis group.
- if the patient accepts, he will benefit from hypnosis during LP.
- if the patient refuses, he will re-join the control group without hypnosis.
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
- None
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
- •Required a lumbar puncture for diagnosis
- •Affiliated with social security system
- •Patient's written consent
排除标准
- •LP contraindication
- •History of previous LP
- •Psychiatric disorder making the realization of a hypnosis irrelevant
- •Cognitive-behavioural abilities that do not allow the completion of the study
- •Persons who are protected under the act. Person deprived of liberty by judicial decision
- •Pregnant or Breastfeeding woman
结局指标
主要结局
Maximum pain felt during LP
时间窗: Immediately at the end of LP procedure
The maximum pain experienced will be assessed in the immediate post procedure using a Numeric Pain Rating Scale (NPRS). The NPRS is a 10 points scale, ranging from 0 (no pain) to 10 (maximal pain).
次要结局
- Ratio of patients with a Numeric Pain Rating Scale (NPRS) score >= 4.(Immediately at the end of LP procedure)
- Comfort felt during LP(Immediately at the end of LP procedure)
- Acceptation of hypnosis(Day1)
- State and Trait anxiety before LP(Before randomization)
- Assess pain at Day 3 and Day 7(Three days and then seven days after the LP.)
- Timeframe for resumption of usual activities.(Seven days after the LP.)
研究者
研究点 (2)
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