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

NCT03853265 | Completed

• 1 other identifier: HM20015131
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Control

NO INTERVENTION

Virtual Reality

EXPERIMENTAL

Simulated dental office visit

Behavioral: Simulated dental office visit

Interventions

Simulated dental office visit BEHAVIORAL

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

Virtual Reality

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Autism Spectrum Disorder (ASD)

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Tegwyn Brickhouse, DDS

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study is parallel design with control group having the option of receiving treatment after study data is collected from initial treatment group

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: February 25, 2019
• Study Start: October 23, 2019
• Primary Completion: February 17, 2020
• Study Completion: February 17, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)