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Clinical Trials/NCT03853265
NCT03853265
Completed
Not Applicable

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

Virginia Commonwealth University1 site in 1 country5 target enrollmentOctober 23, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Virginia Commonwealth University
Enrollment
5
Locations
1
Primary Endpoint
Change in heart rate
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 23, 2019
End Date
February 17, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Autism Spectrum Disorder (ASD)

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change in heart rate

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Study Sites (1)

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