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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simulated dental office visit
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Autism Spectrum Disorder

Eligibility Criteria

5 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Virtual Reality

Arm Description

Simulated dental office visit

Outcomes

Primary Outcome Measures

Change in heart rate
Heart rate measured by a fitbit worn on the wrist during the visit
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).
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)

Secondary Outcome Measures

Full Information

First Posted
February 22, 2019
Last Updated
November 6, 2020
Sponsor
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT03853265
Brief Title
The Effect Of Virtual Reality Glasses On The Behavior Of Children With Autism Spectrum Disorder
Official Title
The Effect Of Virtual Reality Glasses On The Behavior Of Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
February 17, 2020 (Actual)
Study Completion Date
February 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
Simulated dental office visit
Intervention Type
Behavioral
Intervention Name(s)
Simulated dental office visit
Intervention Description
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 Measure Information:
Title
Change in heart rate
Description
Heart rate measured by a fitbit worn on the wrist during the visit
Time Frame
Baseline to 2 week follow up
Title
Change in 5-point Venham Anxiety Scores
Description
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).
Time Frame
Baseline to 2 week follow up
Title
Change in 5-point Venham Uncooperative Behavior Scores
Description
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)
Time Frame
Baseline to 2 week follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tegwyn Brickhouse, DDS
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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