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

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: Simulated dental office visit

• Registration Number: NCT03853265
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study First Submitted: 2019-02-22
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Study Start: 2019-10-23
• Primary Completion: 2020-02-17
• Study Completion: 2020-02-17
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Virtual Reality	Simulated dental office visit	Simulated dental office visit

Primary Outcome Measures

Name	Time	Method
Change in heart rate	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	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	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)

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States