A Randomized Controlled Trial of Virtual Reality for Pain Management in the Post-Operative Period Following Orthopedic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Timing of pain medication
研究概览
简要总结
Use an RCT study design to measure pain experience, medication use, medical side effects, and length of hospital stay with and without availability of VR following spine fusion surgery
详细描述
The purpose of this study is to prospectively assess the utility of virtual reality (VR) for pain and anxiety management in the post-operative period following major orthopedic surgery. While there is substantial evidence supporting the use of VR during dressing changes for burn victims, there is little known about VR use in post-surgical settings. In the proposed study, patients will be randomized to either receive VR in addition to standard of care or to receive only standard of care during their post-operative care following spinal fusion surgery for idiopathic scoliosis or neuromuscular scoliosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is having a spinal fusion at Gillette Children's Specialty Healthcare
- •Patient with a diagnosis of adolescent idiopathic scoliosis (AIS) or a diagnosis of neuromuscular scoliosis
排除标准
- •Non-English speaking parents/patients
- •Patients with history of motion sickness
- •Patients with epilepsy
- •Patients with a ventricular shunt
- •Patients with severe/profound cognitive impairments
研究组 & 干预措施
Virtual Reality Post Spinal Fusion
Patients randomized to the VR group will have the opportunity to utilize VR during the post operative period, and will also experience VR during research visits each day following surgery.
干预措施: Virtual Reality (Device)
Standard of Care
Patients randomized to the non-VR condition will experience the usual standard of care following spinal fusion surgery. This will include 15-30 minutes of movie viewing during research visits.
结局指标
主要结局
Timing of pain medication
时间窗: 4 days
Timing of morphine equivalent opioids (mg/kg/day) and adjunctive medications (e.g., Tylenol, Diazepam, Propofol, Midazolam, etc.; mg/kg/day).This will be collected retrospectively from the patient medical record following the conclusion of treatment.
Doses of pain medication
时间窗: 4 days
Doses of morphine equivalent opioids (mg/kg/day) and adjunctive medications (e.g., Tylenol, Diazepam, Propofol, Midazolam, etc.; mg/kg/day).This will be collected retrospectively from the patient medical record following the conclusion of treatment.
次要结局
- Length of stay(4 days)
- Pain assessment scores(4 days)
- Parents' Postoperative Pain Measure(4 days)
- Visual analogue scale(4 days)
- Faces Pain Scale-Revised(4 days)
- Time patient out of bed(4 days)
研究者
Chantel Burkitt
Principal Investigator
Gillette Children's Specialty Healthcare