Technology-Based Distractions for Minor Procedures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures
研究概览
简要总结
The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headset, Augmented Reality Headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). The anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.
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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patient age between 4-17
- •English speaking
- •Parental consent/patient assent
- •Undergoing minor procedure(s) at LPCH or Stanford Hospital
排除标准
- •Patient does not consent
- •Legal guardian not present to obtain consent
- •Patient with a significant neurological condition or major developmental disability
- •Patient experiencing nausea
- •Patient with active infection of the face or hand
- •A history of severe motion sickness
- •A history of visual problems
- •A history of seizures caused by flashing light
- •Major surgery within the last 48 hours
- •Patients who are clinically unstable or require urgent/emergent intervention
- •Patient or parental preference for general anesthesia
研究组 & 干预措施
Standard of Care group
No immersive technology will be assigned to the participant. Participant will use their own distraction method.
干预措施: Standard of Care (Behavioral)
Immersive Technology grorup
Immersive technologies including VR headsets, a bluetooth haptic device (Buddy Guard), a screen and projector (BERT), and a tablets with a game will be randomly assigned to the participants. Each participant will receive one technological intervention.
干预措施: Immersive technology (Behavioral)
结局指标
主要结局
Evaluate the effectiveness of technological interventions on anxiety levels in patients who undergo minor procedures
时间窗: baseline, immediately after the intervention
Participants will complete the Visual Analogue Scale for Anxiety (VAS-A), a self-report scale to measure anxiety levels before and after the technological intervention. The scale is a horizontal line from 0 to 10 with an anchor at 0 indicating "no anxiety" and an anchor at 10 indicating "worst possible anxiety".
次要结局
- To evaluate the patient's cooperation during the intervention using the modified Induction Compliance Checklist (mICC)(during minor procedure)
- Evaluate the effectiveness of technological interventions on pain levels in patients whose age is 4-11 years old and undergo minor procedures(baseline, immediately after the intervention)
- To evaluate pain levels pre- and post-intervention, participants will complete the Numerical Rating Pain Scale (NRPS) for patients 12-17 years old.(baseline, immediately after the intervention)
- To evaluate patient's, clinician's, and caregiver's satisfaction levels(immediately after the intervention)
- To evaluate the patient's affect during the intervention using HRAD(during minor procedure)
研究者
Thomas Caruso
Clinical Professor
Stanford University