Virtual Reality for Dental Anxiety in Children With Mild Intellectual Disability

NCT ID: NCT07249359

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Intellectual Disabilities (F70-F79)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality Distraction

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Control: Monitor-Based Distraction

cartoon video displayed in front of dental chair

Group Type ACTIVE_COMPARATOR

Control: Monitor-Based Distraction

Intervention Type DEVICE

cartoon video displayed in front of dental chair

Interventions

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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

Intervention Type DEVICE

Control: Monitor-Based Distraction

cartoon video displayed in front of dental chair

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oasi Research Institute-IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Ass. Oasi Maria SS

Troina, EN, Italy

Site Status

Countries

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Italy

Other Identifiers

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RC-2794677

Identifier Type: -

Identifier Source: org_study_id

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