Application of Virtual Reality in Post-Operative Recovery of a Pediatric Scoliosis Patient Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Average Change in Subjective Pain Level Using a 10 Point Likert Scale
研究概览
简要总结
The purpose of this study is to assess the effect of virtual reality on subjective post-operative pain, total inpatient narcotic administration, and mobilization with physical therapy in pediatric patients who have undergone surgical correction for idiopathic scoliosis.
详细描述
All pediatric patients (ages 13-18) at Connecticut Children's Medical Center undergoing corrective scoliosis surgery for idiopathic scoliosis are eligible and will be approached for consent and inclusion into the study. This is a prospective pilot study, and all enrolled patients will receive a virtual reality (VR) intervention using a commercially available device manufactured by Oculus. The VR software will simulate a low physical load environment, such as an underwater space exploration game. Starting on postoperative day 1, the prospective cohort will undergo a 20-minute VR session 30 minutes prior to each physical therapy session. There will be two physical therapy sessions scheduled daily for the participant. Outcome measures will be assessed before and after the VR session and after the physical therapy session. The following procedures will continue daily until the participant is cleared for hospital discharge. Patients that met study eligibility but elected not to participate in the VR intervention were analyzed as the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All pediatric patients (ages 13-18) at Connecticut Children's undergoing surgical correction for idiopathic scoliosis over a span of 12 months
排除标准
- •History of seizures
- •Cognitive developmental delay precluding participation in VR
- •Head or neck surgery that does not allow a head-mounted display to be worn safely
- •Chronic pain requiring the daily use of opioids for more than 2 weeks prior to the procedure
- •Non-English speakers
- •Side effects during screening
- •Patients with vagal nerve stimulators, cardiac pacemakers, and/or cochlear implants that may receive interference from the VR device
结局指标
主要结局
Average Change in Subjective Pain Level Using a 10 Point Likert Scale
时间窗: 2 times daily postoperatively until hospital discharge (up to 60 days postoperatively)
This tool uses a 10-point scale that ranges from 0 (no pain) to 10 (worst possible pain). Pain will be assessed using this tool before and after every physical therapy session. The change in pain before and after each physical therapy session will be calculated and averaged across each patient.
次要结局
- Total Amount of Administered Opioids During the Post-operative Period(From post-operative day 1 until hospital discharge (up to 60 days postoperatively))
- Average Number of Physical Therapy Sessions Prior to Receiving Clearance by Physical Therapy Staff(Post-operative day 1 until clearance by physical staff (up to 60 days postoperatively))