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

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ClinicalTrials.gov Identifier: NCT03853265
Recruitment Status : Not yet recruiting
First Posted : February 25, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


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




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)



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853265


Contacts
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Contact: Robert Lunka, DDS (804) 828-9095 lunkar@mymail.vcu.edu
Contact: Tegwyn Brickhouse, DDS thbrickhouse@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Tegwyn Brickhouse, DDS Virginia Commonwealth University

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03853265     History of Changes
Other Study ID Numbers: HM20015131
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders