Pain's Treatment With Virtual Reality in Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Pain measured by using the revised Faces Pain Scale - Revised (FPS-R)
研究概览
简要总结
Pain is a frequent and difficult to treat symptom in patients with advanced kidney disease undergoing hemodialysis. Pharmacokinetics and pharmacodynamics have complex pharmacokinetics and pharmacodynamics in these types of patients, so non-pharmacological therapies could be very useful. In this project the investigators propose to test whether the use of a virtual reality platform, designed by the company Psious and tested in other clinical settings, can reduce the pain that patients experience during connection to the dialysis session.
For this the investigators have designed a crossover clinical trial, which will be carried out on 107 hemodialysis patients, in which the intensity of pain (primary objective) and anxiety (secondary objective) that patients experience in the sessions in which participants are treated Using virtual reality, it will be compared with the intensity of pain and anxiety experienced by these same patients, in sessions in which the virtual reality platform is not used.
The results of this clinical trial can support the use of virtual reality as an adjunctive pain treatment in patients with advanced kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Hemodialysis for at least 3 months
- •Pain for for at least 3 months
- •Signature of informed consent
排除标准
- •Pain from a traumatology disease
- •Formal diagnose of dementia
结局指标
主要结局
Pain measured by using the revised Faces Pain Scale - Revised (FPS-R)
时间窗: From the moment of connection to dialysis until 30 minutes later
Pain measured by using the revised Faces Pain Scale - Revised (FPS-R). The scale ranges from 0 to 10, with 0 being the absence of pain and 10 being the maximum pain
次要结局
- Anxiety measured by using the Hamilton scale(From 1 hour before dialysis connection to 30 minutes after)