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

• ClinicalTrials.gov Identifier: NCT03853265
• Recruitment Status: Completed
• First Posted: February 25, 2019
• Last Update Posted: November 9, 2020
• Sponsor: Virginia Commonwealth University
• Information provided by (Responsible Party): Virginia Commonwealth University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorder	Behavioral: Simulated dental office visit	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention 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 (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect Of Virtual Reality Glasses On The Behavior Of Children With Autism Spectrum Disorder
• Actual Study Start Date: October 23, 2019
• Actual Primary Completion Date: February 17, 2020
• Actual Study Completion Date: February 17, 2020

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control
Experimental: Virtual Reality; Simulated dental office visit	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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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).
3. 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)

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

• Principal Investigator: Tegwyn Brickhouse, DDS; Virginia Commonwealth University

More Information

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT03853265
• Other Study ID Numbers: HM20015131
• First Posted: February 25, 2019
• Last Update Posted: November 9, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders