Hypnosis Mask: a New Approach to Management of Pain in Medical Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Visual analogic Scale
研究概览
简要总结
The prostatic biopsies echo-guided are a painful and stressful. The purpose is to test a new medical device created recently, " Hypnos-Pro ", wich uses connected technologies. This connected device is a mask with diodes coupled with an audio headset and a touch pad. This connected mask is an another option to induce an hypnotic state for our patients. the objective is to value hypnotic mask effectiveness, to reduce the level pain and anxiety for the patients who benefit a prostatic biopsies echo-guided with local 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 (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient eligible for prostate biopsies
- •Having accepted and signed the consent, for performing a prostate biopsy ultrasound examination
- •No contraindication to the gesture
- •Supporting the left lateral decubitus
排除标准
- •Patient isolation contact / droplets
- •Patient with hearing and / or epilepticus and / or dementia and / or having a history of stroke and / or allergic to lidocaine
- •Person unable to consent, or benefiting from a system of legal protection (tutelage / curatorship).
- •Patients with epileptic seizures.
- •Patients with known allergies to plastics and other resins that may develop allergic contact dermatitis.
- •Patients who are hypersensitive to radio frequency.
研究组 & 干预措施
standard pain management
干预措施: Periprostatic nerve block (Procedure)
Optimizing pain management
An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro).
干预措施: Periprostatic nerve block (Procedure)
Optimizing pain management
An experimental group receive a standard pain management and benefit the hypnotic mask (Hypnos pro).
干预措施: hypnosis mask (Device)
结局指标
主要结局
Visual analogic Scale
时间窗: at 20 minutes after the removal of the probe
Measure the pain in the scale from 0 to 10
次要结局
- State-Trait Anxiety Inventory ou STAI forme Y-A(Baseline, at 20 minutes after the removal of the probe)
- Percentage of positive response of satisfaction of the operator(at 20 minutes after the removal of the probe)
- Percentage of positive response of satisfaction of the patient(at 20 minutes after the removal of the probe)