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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03853265
• Other study ID #: HM20015131
• Status: Completed
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: February 17, 2020

Study information

• Verified date: November 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: February 17, 2020
• Est. primary completion date: February 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• Simulated dental office visit
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

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate	Heart rate measured by a fitbit worn on the wrist during the visit	Baseline to 2 week follow up
Primary	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
Primary	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