Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds: Multicentric Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- Treatment-induced pain
研究概览
简要总结
Pain management is a priority axis of health insurance spending objectives and contributes to improving the quality of care.There are several types of pain: acute, chronic and induced. These are often found in the management of chronic wounds. The high prevalence of chronic wounds represents a major public health problem. Chronic wounds require long, painful and regular treatment. When dressing these wounds, pain management is essential. Indeed, it can generate healing delays. Usually, pharmacological methods are used to reduce the pain induced by care. But these methods can lead to undesirable effects. Thus, new non-pharmacological techniques are emerging.The investigators therefore wish to assess the effect of virtual reality on pain induced by care during the repair of dressings in the management of chronic wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Knowing how to read and write French
- •Able to understand the issues of the study and give consent
- •Carrier of a chronic wound (ulcers, bedsores or wounds of the diabetic foot)
- •Requiring a weekly dressing treatment in the department for at least 4 successive treatments(4 weeks)
- •With pain during pre-inclusion care at least ≥3 to the Visual Analog Scale
- •Person with cognitive and sensory capacities adapted to Virtual Reality (pre-inclusion verification on a device test of 5 to 10 minutes)
- •Person affiliated or beneficiary of a social security scheme
排除标准
- •Carriers of a wound located on the face or end of the head and interfering with the proper use of the Virtual Reality mask
- •Visually impaired and / or hard of hearing impacting the correct use of the Virtual Reality mask (test of 5 to 10 minutes of the device during the pre-inclusion visit)
- •Patient not fluent in French.
- •Current diagnosis of epilepsy, dementia or other neurological diseases preventing the use of Virtual Reality hardware and software
- •Patients under guardianship or curators
结局指标
主要结局
Treatment-induced pain
时间窗: 4 weeks
(AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable
次要结局
- Level of situational anxiety(4 weeks)
- Duration of treatment(4 weeks)
- Frequency of use of analgesic(4 weeks)
- Time spent thinking about pain(4 weeks)
- Medical Outcome Study Short Form(4 weeks)
- Worse Treatment-induced pain(4 weeks)
- Healing process(4 weeks)
- Tolerance of virtual reality(4 weeks)