Single Center Study Evaluating the Possible Effect of Virtual Reality Spectacles on Pain Following Total Knee Replacement Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- VAS pain response
研究概览
简要总结
The trial aims to evaulate the possiblity that use of virtual reality spectacles will affect post operative pain in total knee arthroplasty patients. The trial is a single center open label design. Patients will be randomized into two arm study comparing the effect of the use of virtual reality spectacles on pain levels and analgesic consumption in the perioperative period. The controls shall receive standard post operative care. The endpoints are VAS levels and analgesic use.
详细描述
Evaluation Procedure This is a single center, interventional, randomized, unblinded two arm study assessing pain and analgesic use in post knee arthroplasty patients. The randomization ratio is 2:1 intervention to control. Both groups will receive routine post operative care. The intervention group will be treated with virtual reality spectacles. The control group will receive routine post operative care. Pain levels will be assessed using VAS and analgesic use.
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
- •Patients undergoing total knee arthroplasty gender indifferent, aged over 18 years old
- •Patient with ability to see in three dimensions
排除标准
- •Inability to comply with the study protocol
- •Single eye vision
- •Blindness
研究组 & 干预措施
Conventional therapy
Patient undergoing conventional analgesic therapy after total knee replacement
干预措施: No VR glasses (Device)
Virtual reality glasses
Patient undergoing conventional analgesic therapy after total knee replacement and treated with virtual glasses
干预措施: Virtual reality glasses (Device)
结局指标
主要结局
VAS pain response
时间窗: One week
questionnaires
次要结局
- Analgesic use(one week)
研究者
DROR ROBINSON
Head of orthopedic research unit
Rabin Medical Center