Stress Inoculation Through Virtual Reality in the Pediatric Electrophysiology Laboratory
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in anxiety levels from baseline in patients as measured by the State Trait Anxiety Inventory (STAI).
研究概览
简要总结
The goal of this study is to assess the utility of virtual reality technology to aid in the mental health of patients with cardiac disease, specifically looking at decreasing anxiety and perceptions of pain from stressful procedures in the pediatric electrophysiology laboratory.
详细描述
The investigators will perform a pilot study of 40 patients who are randomized to either standard of care preparation for an electrophysiology procedure (control arm) vs. Virtual Reality preparation (VR arm). Participants in control arm will have standard preparation for a procedure including discussion of the procedure with the provider the day before the procedure with all questions answered at that time. VR arm participants will have access to the Virtual Reality tour and gear 1 week prior to the procedure. VR arm participants will be instructed to watch the Virtual Reality tour at least three times prior to the procedure but will be encouraged to watch as often as the participants would like. The Virtual Reality equipment will measure how often participants complete the tour. All participants will undergo anxiety measures a total of four times: once at time of recruitment, day of procedure and then 1 week and 4 weeks post procedure. Participants will have cortisol salivary swabs performed 1 week before procedure (before VR use), pre-op visit, day of procedure, and immediately following procedure. Heart rate and blood pressure will be measured on day of procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric Cardiology patients between the age of 10 and 20 years old
- •Undergoing cardiac electrophysiology procedure
排除标准
- •Inability to wear virtual reality glasses
- •Patients under 10 years old
- •Prior psychiatric illness
研究组 & 干预措施
Standard of Care
No research intervention to be administered.
Participants will have standard preparation for a procedure including discussion of the procedure with the provider the day before the procedure with all questions answered at that time.
Virtual Reality
The VR interactive module will consist of a 360° visit to the Hospital where patients encounter the various aspects of a procedure from the front door; through the pre-operative area where patients will receive an IV; to the catheterization lab and placement of the anesthesia mask; and back to the post anesthesia care unit. Patients will be accompanied by a child who acts as a guide to the experience. The guide will help explain what the patient is seeing and what to expect along the way. Health care professionals will be enmeshed within the scenarios and will also help with the explanations along the way. Patients will be prompted to enter the relaxation scenarios at different stressful times along the tour to practice relaxation and mindfulness techniques (i.e. before IV start, or upon entering catheterization laboratory). Relaxation scenarios will include a snow scene, tropical beach or other guided imagery scenes.
干预措施: Use of Virtual Reality App (Behavioral)
结局指标
主要结局
Change in anxiety levels from baseline in patients as measured by the State Trait Anxiety Inventory (STAI).
时间窗: At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure
State -Trait Anxiety Inventory (STAI) is a widely used self-report measure that estimates situational (state) and baseline (trait) anxiety in adults and children. It is both valid and reliable and routinely used in measuring anxiety associated with medical procedures. The pediatric version is available for use with upper elementary, or junior high or high school aged children.
次要结局
- Change in anxiety levels from baseline in parents as measured by parental STAI(At time of recruitment, day of procedure, 1 week post procedure, and 4 weeks post procedure)
- Change in parent observation of child behavior from baseline as measured by Child Behavior Checklist (CBCL)(At time of recruitment and 4 weeks post procedure)
- Heart rate in patients(Day of procedure)
- Change in anxiety levels from baseline in patients as measured by Visual Analog Scale of Anxiety(At time of recruitment, day of procedure)
- Change in salivary cortisol levels from baseline in patients(1 week before procedure (before use of VR), Day of pre-op, Day of procedure, Day after procedure or immediately after procedure if outpatient)
- blood pressure in patients(Day of procedure)
研究者
Anne M. Dubin
Professor of Pediatrics
Stanford University