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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT03853265
Collaborator
(none)
5
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2
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Study Details

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
  • Behavioral: Simulated dental office visit
N/A

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
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 groupStudy 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 :
Oct 23, 2019
Actual Primary Completion Date :
Feb 17, 2020
Actual Study Completion Date :
Feb 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 [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 [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 [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

Criteria

Ages Eligible for Study:
5 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 Virginia Commonwealth University Richmond Virginia United States 23298

Sponsors and Collaborators

  • Virginia Commonwealth University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT03853265
Other Study ID Numbers:
  • HM20015131
First Posted:
Feb 25, 2019
Last Update Posted:
Nov 9, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
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:

Study Results

No Results Posted as of Nov 9, 2020