Interest of Immersive Virtual Reality on Stress During Botulinum Toxin Injections in Spasticity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Heart rate variability (HRV) before injection and during the injections
研究概览
简要总结
The main objective of the study is to investigate the effect of exposure to a virtual reality session during botulinum toxin injections on injection-induced stress.
The secondary objectives are to study the effect of exposure to a virtual reality session during botulinum toxin injections, on the pain induced by the injection. And study the evolution of the effects of virtual reality with the repetition of the sessions.
详细描述
Botulinum toxin injections is very frequently used in the treatment of spasticity after central neurological damage (stroke, multiple sclerosis, spinal cord injury, head trauma). The injections may be painful and the tolerance of the injections varies from one patient to another. The pain felt during the injection causes in most patients great stress during the injection.
Virtual reality is a video technique with 360 ° vision simulating the physical presence of the patient in an "existing" environment outside the hospital setting. This technique has been used in painful procedures but only one publication, in pediatrics, has shown a decrease in pain and agitation during botulinum toxin injections.
The hypothesis of this research is that an immersive virtual reality system can, in adults, reduce stress and the painful experience of botulinum toxin injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The processing of the heart rate data will be carried out blind from the device used. Indeed, the investigator must not be aware of the device used during the session so as not to have an influence and draw hasty conclusions.
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
- •Adult patient, male or female, suffering from spasticity of neurological origin (multiple sclerosis, stroke, head trauma, etc.) and eligible for treatment by botulinum toxin injection
- •Able to give an informed consent to participate in research
- •Affiliation to Social Security.
排除标准
- •Contraindication to virtual reality (epilepsy, schizophrenia, strabismus, amblyopia, anisometropia, local contraindication to wearing a helmet (lesion of the face or the skull)
- •Major cognitive disorders
- •Any medical condition deemed by the investigator to be incompatible with the research.
- •Indication of sedation by MEOPA during botulinum toxin injection sessions.
- •Patients who have already experienced virtual reality
- •Drug treatment or medical condition that may affect heart rate variability
- •Pregnant or breastfeeding women
- •Patients under safeguard of justice
- •Refusal of participation.
结局指标
主要结局
Heart rate variability (HRV) before injection and during the injections
时间窗: during the procedure
The stress measurement is carried out using a watch and a belt (heart rate monitor) which, thanks to several parameters, will allow us to carry out an HRV analysis on the KUBIOS software.
次要结局
- Effect on the pain induced by the injection(during the procedure)
- Quality of the conditions for performing botulinum toxin injections(during the procedure)