A Randomized Control Trial of Virtual Reality to Reduce Anxiety During Pediatric Cast Removal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Change from baseline heart rate during cast removal procedure
研究概览
简要总结
This study is a randomized control trial of Virtual Reality during cast removal procedures at a pediatric tertiary care center.
详细描述
Cast removal is a common outpatient procedure and is a source of pain and anxiety for children. Children are often frightened by the appearance and the noise of the saw. Additionally, the saw blade can become warm, and this can be uncomfortable. Multiple methods have been used and studied to try to make this experience easier for children. These methods include: soft music, therapeutic play, and headphones. Virtual reality (VR) devices are now increasingly affordable and portable. VR could be a way to distract children from the appearance and sound of the procedure. VR has been used in other clinical settings to help patients with the anxiety associated with medical procedures. The investigators propose a randomized trial to assess the responses (e.g. questionnaires and monitors) of children to cast removal with VR versus the standard noise reduction headphones.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sustained a fracture in their arm/leg
- •No previous experience with a cast removal
- •Must have at least one wrist free of immobilization (for heart rate monitor)
- •Parents and patient are English speaking
排除标准
- •Patients with a history of epilepsy, ventricular shunt, motion sickness
- •Patients with any history of cognitive, visual or hearing impairment
研究组 & 干预措施
Virtual Reality
Participants will experience Virtual Reality during their cast removal
干预措施: Virtual Reality (VR) (Device)
Standard of care
Participants will receive their usual standard of care treatment during cast removal
结局指标
主要结局
Change from baseline heart rate during cast removal procedure
时间窗: Heart rate will be measured during the cast removal procedure. As this is a single visit study, heart rate will not be measured at any other time periods throughout the study.
The change from baseline heart rate during cast removal procedure obtained by using an electronic monitoring wristband and measuring heart rate 15 seconds prior to and continuously during the cast removal procedure.
次要结局
- Visual Analog Scale (VAS): Patient anxiety during cast removal(The VAS anxiety assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.)
- Change in Parent Reported Wong-Baker FACES Pain Scale Rating(The Wong-Baker FACES Pain Scale assessment will be collected 1 minute prior to and immediately after cast removal.This is a single visit study and the assessment will not be measured at any other time periods.)
- Change in Patient Reported Wong-Baker FACES Pain Scale Rating(The Wong-Baker FACES Pain Scale assessment will be collected 1 minute prior to and immediately after cast removal.This is a single visit study and the assessment will not be measured at any other time periods.)
- Visual Analog Scale (VAS): Parental anxiety during cast removal(The VAS anxiety assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.)
- Visual Analog Scale (VAS): Parent Reported Worst Pain During Treatment(The VAS parental worst pain assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.)
- Visual Analog Scale (VAS): Parental Satisfaction(The VAS parental satisfaction assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.)
- Visual Analog Scale (VAS): Parental Assessment of Pleasantness(The VAS parental satisfaction assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.)
- Visual Analog Scale (VAS): Patient Reported Worst Pain During Treatment(The VAS patient worst pain assessment will be performed immediately after the cast removal procedure, which is expected to last 5-10 minutes.This is a single visit study and the assessment will not be measured at any other time periods.)
研究者
Andrew G. Geoergiadis
Pediatric Orthopedic Surgeon
Gillette Children's Specialty Healthcare