Virtual Reality Usage in Non-Invasive Surgical Sub-Specialty Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 2
- 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, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting device (Virtual Reality (VR) headset, Augmented Reality (AR) headset, or bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment Theater)) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before non-invasive surgical sub-specialty procedures among children during out-patient clinic visits. Examples of the most common procedures include, but are not limited to gastrostomy tube exchanges, suture removals, dressing changes, foley insertions, EEG set up, chest tube removals, cast removals, pin removals and other similar procedures. (The investigators refer to these procedures under an umbrella term of non-invasive surgical subspecialty procedures). The anticipated primary outcome will be reduction of child's anxiety during and after procedures.
详细描述
Anxiety among children undergoing non-invasive surgical subspecialty procedures is common. Not only is high anxiety traumatic, but research in a surgical setting 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 that may arise when experiencing a non-invasive surgical subspecialty procedure in a clinical setting.
In this study, investigators hope to determine if technology based distractions (VR headsets with headphones, AR headset, or BERT projector) are more effective than standard care for preventing high anxiety before non-invasive surgical subspecialty procedures. As a secondary objective of the study, the investigators seek to determine if the use of technology based distraction will result in higher parent and patient satisfaction as well as evaluate which techniques are most effective. As a tertiary aim, the investigators seek to understand if passive or active interventions are more effective in decreasing anxiety.
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
- 2 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 2-18 years of age
- •Have comprehension of instructions in the English language
- •Have parental consent
- •Pediatric patients must be undergoing non-invasive surgical subspecialty procedures at an Lucile Packard Children's Hospital (LPCH) out-patient clinic
- •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 >24 hours or without the operation)
- •Children currently taking psychotropic mediations will be excluded from this study due to the affect emotion modulation
- •Strong parental or patient preference for pharmacological anxiolytic
- •Strong parental or patient preference for specific anxiety-reducing technique
结局指标
主要结局
Change in Pain Score
时间窗: Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline
Peak Pain Score minus Baseline Pain Score. Pain scores range from 0 to 10. 0 represents no pain and 10 represents the worst pain possible. Change in pain score ranges from +10 to -10. Higher positive values represent a worse outcome, and higher negative values represent a better outcome.
次要结局
- Anxiety Score(Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline)
- Patient Compliance(At the time of Non-Invasive Surgical Subspecialty Procedure)
- Family Satisfaction(Immediately Post Non-Invasive Surgical Subspecialty Procedure)
- Parent Pain Catastrophizing Scale (PCS-P)(Baseline and Immediately Post Non-Invasive Surgical Subspecialty Procedure)
- Anxiety Meter(Immediately Post Non-Invasive Surgical Subspecialty Procedure Minus Baseline)
- Patient Satisfaction(Immediately Post Non-Invasive Surgical Subspecialty Procedure)
- Patient Cooperation(At the time of Non-Invasive Surgical Subspecialty Procedure)
研究者
Samuel Rodriguez
Assistant Professor, Department of Anesthesiology, Perioperative and Pain Medicine
Stanford University