Healthy Volunteer Undergoing Painful Stimuli With and Without Virtual Reality Hypnosis (VRH)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Compare physiological and neurophysiological changes to painful stimulation with and without Hypnosis and Virtual Reality (HVR)
研究概览
简要总结
The main purposes of this study are as follows:
Compare the effect of painful stimuli with and without Hypnosis and Virtual Reality (HVR) on healthy volunteers.
- Use of sensors and captors to monitor physiological and neurophysiological changes by painful stimulus
- Monitor level of pain and anxiety with and without HVR
- Monitor level of unpleasantness of the pain with and without HVR
- Monitor level of Anxiety, Absorption, Dissociation, Satisfaction and Comfort with and without HVR
详细描述
The control of pain and anxiety in a hospital environment is usually managed by pharmacological means that involve a series of risks and side effects.
For many years, non-drug solutions have been of interest to the public and the care staff. The benefits of hypnosis and of virtual reality are highlighted in many studies and today allow a different approach to medicine. It is important to invest in tools that are less expensive and also effective for the well-being of the patient and the care staff. The use of a blended solution using both clinical hypnosis and virtual reality has been only scarcely documented.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 18 years old to 70 years of age
排除标准
- •Deaf subject
- •Non-proficiency in French (research language)
- •Psychiatric disorder
- •Patient under 18 years old
- •Phobia of deep water
- •Head or face wounds
- •Claustrophobia
- •Neurological disease
- •Allergy to cutaneous electrodes
- •Chronic pain and/or chronic analgesics consumption
- •Medication affecting the autonomic nervous system
- •Dizziness
结局指标
主要结局
Compare physiological and neurophysiological changes to painful stimulation with and without Hypnosis and Virtual Reality (HVR)
时间窗: During the procedure
To understand the effect of VRH on the Physiological and neurophysiological parameters recorded by sensors and captors
次要结局
- Pain and anxiety(Immediately before and after the procedure)
- Unpleasantness of the pain(Immediately after the procedure)
- Absorption, Dissociation, Satisfaction and comfort, presence and cybersickness(Immediately after the procedure)