Evaluation of Virtual Reality Intervention After Pediatric Idiopathic Scoliosis Surgery to Reduce Postoperative Pain and Opioid Consumption
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30
研究概览
简要总结
The purpose of this study is to evaluate the use of virtual reality after scoliosis surgery in pediatric patients.
详细描述
Purpose: To evaluate postoperative pain scores and postoperative opioid use in pediatric idiopathic scoliosis surgical patients using virtual reality (VR) as a method of immersive distraction compared with standard electronic use postoperatively.
Participants: Patients age 11-17 undergoing idiopathic scoliosis surgery on Enhanced Recovery After Surgery (ERAS) spine protocol at our institution.
Procedures (methods): Participants will be randomized to intervention arm (VR) or control arm (iPad). Baseline pain and anxiety scores will be assessed. On postoperative day 1, each patient will receive a visit by the research assistant who will assess pain scores, PCA use, etc. The intervention group will be offered a VR device for up to 30 minutes. The control group will be offered an iPad for up to 30 minutes. This visit will be performed twice on postoperative day 1. Follow up survey will be conducted at 48-72 hours and 7-10 days postoperatively.
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
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects age 11 - 17 years of age
- •Patients undergoing idiopathic scoliosis surgery on Enhanced Recovery after Surgery (ERAS) spine protocol (which includes postoperative PCA)
排除标准
- •Patient/caregiver refusal
- •Patients with developmental delay
- •Patients with seizure disorder
- •Non-English-speaking patients
- •Patients with daily opioid use >/= two weeks
- •Patients with uncorrected visual or hearing impairment
- •Patients admitted to pediatric intensive care unit on postoperative day #1
结局指标
主要结局
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=30
时间窗: Recorded at end of intervention (T=30 minutes)
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Participants were allowed to play/interact with intervention for up to 30 minutes. Assessed immediately following first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively.
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=10
时间窗: Recorded at the 10 minute mark (T=10 minutes)
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately during first intervention exposure (T=10 min) during 1 30-minute session on day 1 postoperatively.
Opioid PCA Use at T=0-30
时间窗: Recorded during intervention (T=0-30 minutes)
Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.
Opioid PCA Use at T=30-90
时间窗: Recorded one hour after intervention is complete (T=30-90 minutes)
Opioid use via PCA pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.
Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=0
时间窗: Recorded immediately prior to intervention (T=0 min)
All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively.
Pain Scores Via FACES Scale by Patient at First Intervention Exposure T=30
时间窗: Recorded at end of intervention (T=30 minutes)
All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome. Assessed immediately after first intervention exposure (T=30 min) following 1 30-minute session on day 1 postoperatively.
Pain Scores Via FACES Scale by Patient at Baseline
时间窗: Recorded preoperatively as baseline
All patients will be oriented to the Wong-Baker FACES Pain Rating scale preoperatively. This is a self-assessment scale; patients select a face that illustrates the pain they are experiencing. Scores 0-10, with 0=No hurt and 10=Hurts worst. Higher score indicates a worse outcome.
Pain Scores Via FLACC Scale by Research Assistant at Baseline
时间窗: Recorded preoperatively as baseline
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome.
Pain Scores Via FLACC Scale by Research Assistant at First Intervention Exposure T=0
时间窗: Recorded immediately prior to intervention (T=0 minutes)
The Face, Legs, Arms, Cry and Consolability (FLACC) score will be measured by the trained research assistant. This is an observer assessment scale, with 5 categories (i.e., 'Face', with 0=No particular expression or smile, 1=Occasional grimace or frown, 2=Frequent to constant quivering chin, clenched jaw). Scores 0-2 in each category, for total scores 0-10, with 0=No observed pain and 10=Most observed pain. Higher score indicates a worse outcome. Assessed immediately prior to first intervention exposure (T=0 min) during 1 30-minute session on day 1 postoperatively.
Opioid PCA Use at T=-60-0
时间窗: Recorded for the hour prior to intervention (T=-60-0 minutes)
Opioid use via Patient-Controlled Analgesia (PCA) pump in mcg or mg as appropriate. PCA use will be converted to morphine equivalents at time of data entry. A higher number indicates more opioid used during the time interval. Higher number indicates a worse outcome.
Total Opioid Dose (in Milligram Morphine Equivalents)
时间窗: From anesthesia end through hospital discharge, a total of approximately 2 days
The amount of opioids used by the patient will be recorded in all subjects and converted into milligram morphine equivalents based on chart reviews. This collection method was added to replace PCA pump usage unavailability.
次要结局
- Postoperative Behavioral Changes Via PHBQ-AS Form at 7-10 Days(At approximately 7-10 days postoperatively)
- Postoperative Behavioral Changes Via PHBQ-AS Form at 48-72 Hours(At approximately 48-72 hours postoperatively)
- Patient Satisfaction at 48-72 Hours(At approximately 48-72 hours postoperatively)
- Electronic Device Use(Assessed at time of intervention on postoperative day #1)
- Baseline Anxiety Score Via STAI Short Form Baseline Anxiety Score Via STAI Short Form(Recorded preoperatively as baseline)
- Patient Satisfaction at 7-10 Days(At approximately 7-10 days postoperatively)
- Caregiver Satisfaction at 48-72 Hours(At approximately 48-72 hours postoperatively)
- Caregiver Satisfaction at 7-10 Days(At approximately 7-10 days postoperatively)