Pain Elimination and Anxiety Control Through Experiential Virtual Reality
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 主要终点
- Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement
研究概览
简要总结
The goal of this clinical trial is to determine if active virtual reality is more effective than passive virtual reality and standard of care distraction in decreasing pain in children, from 8 to 21 years old, undergoing intravenous placement in emergency department. The main question[s] it aims to answer [is/are]:
- Will active virtual reality reduce pain score on Faces Pain Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?
- Will active virtual reality reduce anxiety score on Visual Analog Scale - revised and measure of heart rate during intravenous placement for children ages 8 years old to 21 years old more than passive virtual reality and standard of care?
If there is a comparison group: Researchers will compare active group to passive group and standard of care.
Participants will randomized into active virtual reality, passive virtual reality or standard of care arms.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 8 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and adolescents 8-21 years old undergoing IV placement .
- •Ability to understand study procedures and to comply with them for the entire length of the study.
- •Participants and caregiver speaking English or Spanish.
排除标准
- •Participants with psychiatric, developmental delay, visual or auditory deficits that would interfere with virtual reality gameplay (decision based on treating clinicians' evaluation).
- •Participants receiving narcotics, opioids, or anxiolytics 8 hours prior (Tylenol and ibuprofen do not count).
- •Participants with pain so significant that consent/assent is not possible (decision based on treating clinician evaluation).
- •Critically ill Participants (ESI 1).
结局指标
主要结局
Mean Change from Baseline in Pain Scores on Faces Pain Scale - Revised after IV Placement
时间窗: 5 minutes before, immediately after procedure
Pain score on Faces Pain Scale - Revised will be assessed 5 minutes before and immediately after procedure. The minimum score is 0, and the maximum score is 10. Higher scores correlate to a worse outcome (more pain).
次要结局
- Mean Change from Baseline in Anxiety Scores on Visual Analog Scale after IV Placement(5 minutes before, immediately after procedure)
- Mean Change from Baseline in Heart Rate after IV Placement(5 minutes before, during, and immediately after procedure)
研究者
Matan Paret
Principal Investigator
Children's Hospital Los Angeles