Use of a Spatial Computing Device and Augmented Reality and Virtual Reality for Exposure Therapy for Needle and Blood-Injection-Injury Phobia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in anxiety symptoms related to needle phobia and BII
研究概览
简要总结
This case series study seeks to evaluate the use of a Spatial Computing Device and Augmented Reality (AR) and Virtual Reality (VR) as an exposure therapy modality for children and adolescents with needle and blood-injection-injury phobia. This study will take place at Lucile Packard Children's Hospital (LPCH) and Stanford Hospital (Stanford University, Palo Alto, CA).
详细描述
Needle phobia and Blood-Injection-Injury phobia are anxieties that are observed in children, adolescents, and adults undergoing medical/surgical procedures and the use of needles. These phobias can lead to an impediment of care for children or adolescents and may impact their ability to participate in care and/or receive essential treatments. This can lead to significant delays in treatment of individuals and medical trauma for patients who can only receive treatments/procedures using needles after undergoing sedation. Although treatment protocols exist for treating needle and blood-injection-injury phobia in adults, the literature regarding treatment in children and adolescents is limited. Additionally, the use of medications for management of needle phobia can lead to increased medical complications and may not resolve the underlying cause of needle phobia. Recent technological developments have led to the use of virtual reality exposure therapy (XRET) for treating needle and blood-injection-injury phobia, however few studies have been performed in children, and the literature regarding anxiety and clinical outcomes using this treatment modality is lacking in this population. Further, newly developed spatial computing and XR (Mixed Reality) devices have led to advancements in immersion and personalization of images/videos, and as such may lead to increased engagement and clinical efficacy for patients participating in XRET.
The study aims to evaluate the effectiveness of combining cognitive behavioral therapy (CBT) and extended reality exposure therapy (XRET) for treating needle and blood-injection-injury (BII) phobia in children and adolescents. The intervention requires direct observation of human participants' psychological and physiological responses to exposures. These measurements, including anxiety levels and sympathetic/parasympathetic activity, can only be obtained from human subjects to assess treatment efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 11-17
- •Fear of needle
- •Patients screened with the modified APA severity Measure for Specific Phobia (blood, needles, or injections), and have an individual phobia score rated as moderate, severe, or extreme (as described below)
排除标准
- •Legal guardian not present to obtain consent
- •Adolescent with a significant neurological condition, or major developmental disability
- •Adolescent with active infection of the face or hand
- •A history of severe motion sickness
- •A history of seizures caused by flashing light
- •An impending surgery within the last 48 hours
- •Adolescents who wear glasses and cannot use contacts
- •Adolescents with physical disabilities that prevent them from using their hands
- •Patients with substance use disorder in past year
- •Virtual Reality headsets do not fit.
研究组 & 干预措施
Cognitive Behavioral Therapy (CBT) + Extended reality exposure therapy (XRET)
干预措施: Mixed reality (XR) Exposure Therapy (Behavioral)
结局指标
主要结局
Change in anxiety symptoms related to needle phobia and BII
时间窗: Baseline, immediately after the intervention of week 4 and week 5, 6 and 12 weeks after completion of treatment
APA severity Measure for Specific Phobia (APA-SMS) is a validated tool used to assess the severity of specific phobia symptoms, including needle and blood-injection-injury (BII) phobia. The scale has 10 items, rated on a 5-point Likert scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme). The total score ranges from 0 - 40, with higher scores indicating greater severity of phobia. A change in symptom ratings from moderate/severe/extreme rating to mild/none indicates remission of symptoms by the end of intervention.
次要结局
- User engagement(Immediately after final intervention)
- Skin Conductance Response Density (SCRD)(during the first intervention, week 4, week 5 and last intervention.)
- Parasympathetic response indexed by Respiratory sinus arrhythmia (RSA)(during the first intervention, week 4, week 5 and last intervention.)
- Change in Anxiety after virtual exposure(Baseline, immediately after the intervention)
- Change in Anxiety after real exposure(during intervention, immediately after the intervention)
研究者
Thomas Caruso
Clinical Professor
Stanford University