Virtual Reality Distraction for Reduction in Acute Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 2
- 主要终点
- Pain Scores (Numerical Rating Scale)
研究概览
简要总结
Using a randomized controlled design, the investigators goal is to estimate the effect of VR on postoperative analgesia and opioid consumption.
详细描述
Specifically, the investigators propose to test the primary hypothesis that the use of AppliedVR software in Pico G2 4K headsets decreases acute postoperative pain scores (with a 1 point difference considered clinically important) compared to sham treatment on a 0-10 scale 15 minutes after each use in the first 48 hours after surgery or hospital discharge, whichever comes first.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology Physical Status 1-3;
- •Scheduled for elective, primary total hip arthroplasty;
- •Anticipated hospitalization of at least 1 night;
- •Expected to require parenteral opioids for postoperative pain;
- •Able to use IV PCA systems.
- •Exclusion criteria:
- •History of chronic pain or care by a pain management specialist;
- •Use of more than 30 mg/day of oral oxycodone (or equivalent);
- •Greater than 12 weeks of current and continued opioid use;
- •History of seizures, epilepsy, motion sickness, stroke, dementia;
- •Non-English speaking;
- •Women who are pregnant or breastfeeding;
- •History of substance use disorder.
排除标准
- 未提供
结局指标
主要结局
Pain Scores (Numerical Rating Scale)
时间窗: From the end of surgery until 48 hours after surgery or discharge, whichever comes first
The primary outcome was post-intervention pain score, adjusted for the corresponding pre-intervention pain score. Pain scores were measured by the Numerical Rating Scale which ranges from 0 (lowest pain) to 10 (highest pain) We targeted 3 interventions per day for each patient, and thus, correspondingly 3 pre-post pain measurements per day. The reported value is the least squares mean calculated using a mixed model for repeated measures.
次要结局
- Perception of Video System Usability(Once between last intervention time and hospital discharge (up to 8 days after end of surgery))
- Time Weighted Average Pain Score(End of surgery to 48 hours after surgery)
- Total Opioid Consumption(End of surgery to 72 hours after surgery.)
- Post Discharge Analgesia.(One week (7 days) after hospital discharge)