A Randomized Controlled Trial Comparing Virtual Reality Games Versus Nitrous Oxide for Pain Reduction in Common Outpatient Procedures in Pediatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual face scale of Bieri score two weeks after surgery
研究概览
简要总结
Randomized controlled trial reporting the pain levels and pain control/reduction of children at the age of 6-15 undergoing surgical procedures by using virtual reality gaming (VR) compared to nitrous oxide. Therefore, 50 patients in each treatment group are recruited, resulting in 100 children altogether. The pain levels and pain control/reduction is measured by the standard anesthesia protocol normally used when nitrous oxide is applied and questionnaires that are administered to the patients at baseline and two weeks after surgery including both the primary and secondary outcome.
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
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication to undergo an elective minor surgical procedure (removal of percutaneous osteosynthesis or pin material or dressing change)
- •Written informed consent by parents
- •Written informed consent by patient if patient is 14 or 15 years old
排除标准
- •Inability to understand the VR-program
- •Inability to fill in the questionnaire because of language deficiencies
- •Neurologic disorders
- •Respiratory tract infections
- •Intolerance of the VR headset or VR gaming procedure
研究组 & 干预措施
Virtual Reality Gaming
干预措施: Virtual reality gaming (Other)
Nitrous Oxide
Standard procedure
干预措施: Nitrous oxide (Drug)
结局指标
主要结局
Visual face scale of Bieri score two weeks after surgery
时间窗: Two weeks after surgery
Pain scale to measure pain reduction for children at the age 6-9, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)
Visual analogue scale (VAS) two weeks after surgery
时间窗: Two weeks after surgery
Pain scale to measure pain reduction for children at the age 11-15, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)
Change in objective pain reaction measured by heart frequencies
时间窗: During the procedure, estimated to be in average 15-20min
Elevation of the heart rate indicates pain
Visual face scale of Bieri score directly after surgery
时间窗: Directly after surgery (up to 20 minutes)
Pain scale to measure pain reduction for children at the age 6-9, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)
Change in objective pain reaction measured by blood pressure
时间窗: Before (up to 3 minutes) and directly after the surgery (up to 3 minutes)
Elevation of blood pressure indicates pain, we measure the difference between the two measures
Visual analogue scale (VAS) directly after surgery
时间窗: Directly after surgery (up to 20 minutes)
Pain scale to measure pain reduction for children at the age 11-15, the score results in a pain score from 0-10 (0: minimum value, no pain; 10: maximum value, strongest imaginable pain)
次要结局
- Patient satisfaction directly after surgery(Directly after surgery (up to 20 minutes))
- Fun two weeks after surgery(Two weeks after surgery)
- Time limit of virtual reality gaming(During the surgery (estimated to be 3 to 25 minutes))
- Fun directly after surgery(Directly after surgery (up to 20 minutes))
- Patient satisfaction two weeks after surgery(Two weeks after surgery)
研究者
Cordula Scherer
Dr.med
Insel Gruppe AG, University Hospital Bern