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临床试验/NCT03853265
NCT03853265已完成不适用

The Effect Of Virtual Reality Glasses On The Behavior Of Children With Autism Spectrum Disorder

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
2
主要终点
Change in heart rate

研究概览

简要总结

The aim of this study is to determine whether the use of virtual reality glasses showing an immersive video simulation of the dental visit will help decrease anxiety at future appointments by decreasing the element of surprise and increasing the patient's familiarity and comfort level with a specific dental practice environment.

详细描述

After an initial baseline data collection visit to the dental clinic, patients will be placed in the virtual reality (VR) group or the no VR group. Caregivers in the VR group will be given VR glasses. They will be instructed how to access the video and use the glasses. The child/wearer of the glasses will feel immersed in the three-dimensional environment and be able to look around the room as they move down the hallways in the video. The caregiver will be encouraged to have the child wear the VR glasses as often as possible and record the number of times the video is watched. The caregiver will fill out a "records form" which will include the date and time the video was watched. Both groups will then return to the clinic for follow up data collection visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Autism Spectrum Disorder (ASD)

排除标准

  • No specific diagnosis of Autism Spectrum Disorder (ASD)
  • Limited English Proficiency
  • Existing patient of VCU Department of Pediatric Dentistry
  • Parent/guardian determination that child would not be avle to tolerate immersive simulation with VR glasses

结局指标

主要结局

Change in heart rate

时间窗: Baseline to 2 week follow up

Heart rate measured by a fitbit worn on the wrist during the visit

Change in 5-point Venham Anxiety Scores

时间窗: Baseline to 2 week follow up

Level of Anxiety exhibited by participant during dental visit as rated on Venham Anxiety Scale by blinded expert rater. Scale ranges from 0 (relaxed, smiling, willing and able to converse) to 5 (child out of contact with the reality of the threat, loud crying, unable to listen to verbal communication, actively involved in escape behavior).

Change in 5-point Venham Uncooperative Behavior Scores

时间窗: Baseline to 2 week follow up

Cooperative behaviors exhibited by participant during dental visit as rated on Venham Uncooperative Behavior Scale by blinded expert rater. Scale ranges from 0 (total cooperation, no crying or physical protest) to 5 (general protest, no compliance or cooperation)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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