Functional Outcome Response to Engaging Virtual Reality in Pediatric Patients (FOREVR Peds Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Effect of VR-Biofeedback on anxiety
研究概览
简要总结
To determine the feasibility and acceptability of using immersive virtual reality technologies to impact clinical outcomes (e.g., pain and anxiety) and medication utilization (e.g., narcotics) in pediatric patients with acute and chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 7to 21 years
- •Able to read, understand, and speak English
- •Patients in the immediate postoperative period with significant pain being followed by the Acute Pain Service (acute postoperative pain cohort); patients presenting in Same Day Surgery for peripheral IV placement or patients in the CBDI clinic presenting for peripheral IV placement or Port accessing (vascular access cohort); or patients admitted to CCHMC on the Medical Pain Service (chronic pain cohort), or sickle cell patients not on the MPS list.
- •Patients who have undergone bone marrow transplantation or receiving chemotherapy experiencing pain from mucositis
排除标准
- •Outside the age range (< 7 or > 21 years)
- •History of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
- •History of vertigo, dizziness, and/or seizure disorder
- •Conditions that would preclude the application of the VR glasses, such as surgeries of the head and neck
研究组 & 干预措施
VR - Distraction
干预措施: VR - Distraction (Other)
VR - Biofeedback
干预措施: VR - Biofeedback (Other)
结局指标
主要结局
Effect of VR-Biofeedback on anxiety
时间窗: 30 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Distraction on anxiety
时间窗: 30 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Distraction on pain
时间窗: 30 minutes after 10 minute VR session.
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-distraction on anxiety
时间窗: Before 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Biofeedback on pain
时间窗: 30 minutes after 10 minute VR session
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Distraction on anxiety
时间窗: Immediately after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Distraction on anxiety
时间窗: 15 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Distraction on pain
时间窗: Before 10 minute VR session.
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Distraction on pain
时间窗: Immediately after 10 minute VR session.
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Distraction on pain
时间窗: 15 minutes after 10 minute VR session.
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Biofeedback on anxiety
时间窗: Before 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Biofeedback on anxiety
时间窗: Immediately after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Biofeedback on anxiety
时间窗: 15 minutes after 10 minute VR session.
Anxiety scores will be collected. Anxiety will be rated using a numerical rating scale. Anxiety will be rated from 0 - 10. 0 meaning no anxiety 10 being severe anxiety
Effect of VR-Biofeedback on pain
时间窗: Before 10 minute VR session
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Biofeedback on pain
时间窗: Immediately after 10 minute VR session
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
Effect of VR-Biofeedback on pain
时间窗: 15 minutes after 10 minute VR session
Pain scores will be collected. Pain will be rated using a numerical rating scale. Pain will be rated from 0 - 10. 0 meaning no pain 10 being severe pain
次要结局
- Role of anxiety on changes in pain(One time prior to study visit)
- Role of pain catastrophizing(One time prior to study visit)