Evaluation of Technology-Based Stress Reduction Techniques Prior to Vascular Access
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Change in Pain Score
研究概览
简要总结
Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, postoperative pain, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting devices (Virtual Reality headset) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before vascular access among hospitalized children undergoing vascular access prior to anesthesia, procedures, surgery, blood draws, port access, or peripheral IV placement. The anticipated primary outcome will be reduction of child's anxiety during and after vascular access.
详细描述
Anxiety among children undergoing vascular access is common. Not only is high anxiety traumatic, but research indicates that high anxiety in children before surgery leads to adverse outcomes such as increased pain and analgesics requirements, delayed hospital discharge, and maladaptive behavioral changes. Treating anxiety may decrease any of these undesirable behaviors.
In this study, investigators hope to determine if technology based distractions (VR headsets) are more effective than standard care for preventing high anxiety before vascular access. As a secondary aim of the study, we seek to determine if the use of technology based distraction will result in higher parent and patient satisfaction, decreased fear, and increased compliance, while monitoring for side-effects of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •be between ages of 7-18 years of age
- •have comprehension of instructions in the English language
- •have parental consent
- •Pediatric patient must be undergoing non-emergent vascular access at Lucile Packard Children's Hospital in one of the 6 previously defined care areas (please see study design in Section 16).
- •Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II,III)-
排除标准
- •Significant cognitive impairment/developmental delays per parental report or H&P.
- •Children with ASA IV (severe systemic disease that is a constant threat to life) or ASA V (unstable patients not expected to survive >24hours or without the operation)
- •H/o severe motion sickness, nausea, seizures
研究组 & 干预措施
Control
The control group will be provided standard of care, which is no use of technologies.
Intervention Group VR
Interventional arm will use technology based distractions (Virtual Reality)
干预措施: Technology Based Distractions (Behavioral)
结局指标
主要结局
Change in Pain Score
时间窗: immediately post vascular access minus baseline
Peak Pain Score minus Baseline Pain Score(0-10)
次要结局
- Patient Satisfaction(Immediately Post Vascular Access)
- Family Satisfaction(Immediatly Post Vascular Access)
- Patient Compliance(At the time of Vascular Access)
- Adverse Events(At the time of Vascular Access)
- Fear Score(immediately post vascular access minus baseline)
研究者
Samuel Rodriguez
Assistant Professor,Department of Anesthesiology, Perioperative and Pain Medicine
Stanford University