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

Study 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.

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

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Behavioral: Simulated dental office visit


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Study is parallel design with control group having the option of receiving treatment after study data is collected from initial treatment group
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Virtual Reality<br>Simulated dental office visit | Behavioral: Simulated dental office visit<br>* An immersive first-person point of view (POV) video simulation of the dental office in the three-dimensional environment (using a virtual reality headset) which allows participant to look around the room as they move down the hallways which is to be watched/experienced by the participant as often as possible between the initial visit and the follow up visit<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate | Heart rate measured by a fitbit worn on the wrist during the visit | Baseline to 2 week follow up | 
| Change in 5-point Venham Anxiety Scores | 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). | Baseline to 2 week follow up | 
| Change in 5-point Venham Uncooperative Behavior Scores | 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) | Baseline to 2 week follow up |