A Virtual Dental Office Experience for Children With Autism Spectrum Disorder

NCT05196230 | Completed

• 1 other identifier: eREB#209
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the effectiveness of virtual reality (360° video) compared to a social story for reducing pre-visit dental anxiety for children with autism spectrum disorder (ASD) improve the dental visit experience for children, their families, and clinicians. The secondary objective is to perform a cost comparison analysis of the 360° video product as compared to a social story for Holland Bloorview's dental clinic.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Dental visit "completeness"

  The investigators will compare the difference in the number of children who complete each stage of the appointment between the two intervention groups using the clinician-rated, post-visit questionnaire. This questionnaire assesses a five-step checklist of visit completeness (1 = Waiting room, 2 = Sitting in dental chair, 3 = Teeth counting, 4 = Teeth cleaning, and 5 = Fluoride painting).

  During the dental appointment

Secondary Outcomes (1)

• Pre-visit anxiety

  Immediately preceding dental appointment

Other Outcomes (2)

• Heart rate

  During dental appointment

• Cost comparison analysis

  through study completion, an average of 1 year

Study Arms (2)

Experimental Condition (360° Video)

EXPERIMENTAL

The 360° video (experimental) group will be mailed a study tablet with the 360° video prior to the dental visit.

Device: Experimental Condition (360° Video)

Control Condition (Social Story)

ACTIVE COMPARATOR

The treatment-as-usual (control) group will be mailed a study tablet with a social story prior to the dental visit.

Device: Control Condition (Social Story)

Interventions

Control Condition (Social Story) DEVICE

The control condition is a social story, which is treatment as usual for preparing clients for their initial visit at Holland Bloorview's dental clinic. The control condition will be delivered through the study tablet. The investigators will ask parents to read it to their child once a day for the week leading up to their appointment. If the child is reading on their own, the investigators will request that parents be in the room with participants while they are. The social story takes approximately five minutes to read.

Also known as: Treatment as usual

Control Condition (Social Story)

Experimental Condition (360° Video) DEVICE

The 360° video is from the point of view of a seated dental client and the participant will be able to explore the scene around them (navigating through the tablet's touch screen). The simulation will include scenes/features that may be anxiety-provoking for some participants. These will include loud noises commonly encountered in the dentist's office (e.g. tooth brushing, dental drills), as well as social stimuli (e.g. the dental clinician), and new environments (e.g., the dental visit room). The investigators will ensure that participants understand that they can stop at any time (e.g., if they are feeling anxious or overwhelmed), and the investigators will ask parents to explore the 360° video with their child for the week leading up to their appointment.

Experimental Condition (360° Video)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A community diagnosis of ASD
• Aged 4-12
• First time client of Holland Bloorview dental (has not previously received dental services at Holland Bloorview dental)
• Dental appointment at least 3 weeks away from time of initial contact
• Parent-predicted difficulty for child to sit through entire dental appointment

You may not qualify if:

• Parent predicts no difficulty for child to sitting through entire dental appointment

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Azadeh Kushki, PhD

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: January 19, 2022
• Study Start: June 30, 2021
• Primary Completion: May 30, 2024
• Study Completion: December 31, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CA (1)