Virtual Reality for Dental Anxiety in Children With Mild Intellectual Disability

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.

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Key information

Conditions

Intellectual Disabilities (F70-F79) Intellectual Disability Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

11 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Ass. Oasi Maria SS

Troina, EN, 94018, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Distraction - immersive VR software delivered through Meta Quest 3® headset during dental procedure

Device

immersive VR software delivered through Meta Quest 3® headset during dental procedure

Control: Monitor-Based Distraction

Device

cartoon video displayed in front of dental chair

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Oasi Research Institute-IRCCS

Other

Registry information

Official study title

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

Acronym: VR-MID

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Nov 25, 2025
Registry last updated: Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed