Virtual Reality for Dental Anxiety in Children With Mild Intellectual Disability (VR-MID)

November 25, 2025 updated by: Oasi Research Institute-IRCCS

Effect of Virtual Reality on Dental Anxiety in Children With Mild Intellectual Disability: A Randomized Controlled Trial

Virtual reality (VR) is a promising non-pharmacological approach to reduce dental anxiety in children with neurodevelopmental disorders. This randomized controlled trial compared a VR-based distraction intervention with conventional monitor-based distraction in children aged 11-15 years with mild intellectual disability and moderate dental anxiety undergoing conservative dental treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • EN
      • Troina, EN, Italy, 94018
        • IRCCS Ass. Oasi Maria SS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 11-15; diagnosis of mild intellectual disability (DSM-5)
  • Moderate anxiety (Corah DAS 9-12)
  • ≥1 decayed tooth requiring conservative treatment under local anesthesia
  • Informed consent from parents/legal guardians

Exclusion Criteria:

  • no or slight anxiety
  • high or severe anxiety
  • visual disorders
  • neuromuscular comorbidities interfering with cooperation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality Distraction
immersive VR software delivered through Meta Quest 3® headset during dental procedure
Device: Virtual Reality Distraction - immersive VR software delivered through Meta Quest 3® headset during dental procedure
immersive VR software delivered through Meta Quest 3® headset during dental procedure
Active Comparator: Control: Monitor-Based Distraction
cartoon video displayed in front of dental chair
Device: Control: Monitor-Based Distraction
cartoon video displayed in front of dental chair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment success
Time Frame: Duration of procedure
Number of patients with completion of restorative dental procedure under local anesthesia within 50 minutes and positive overall treatment experience (dichotomous: success vs. failure)
Duration of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oasi Research Institute-IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 25, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-2794677

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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