Virtual Reality for Dental Anxiety in Children With Mild Intellectual Disability
VR-MID
Effect of Virtual Reality on Dental Anxiety in Children With Mild Intellectual Disability: A Randomized Controlled Trial
1 other identifier
interventional
56
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedFirst Submitted
Initial submission to the registry
November 17, 2025
CompletedFirst Posted
Study publicly available on registry
November 25, 2025
CompletedDecember 3, 2025
November 1, 2025
5 months
November 17, 2025
November 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Treatment success
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
Study Arms (2)
Virtual Reality Distraction
EXPERIMENTALimmersive VR software delivered through Meta Quest 3® headset during dental procedure
Control: Monitor-Based Distraction
ACTIVE COMPARATORcartoon video displayed in front of dental chair
Interventions
immersive VR software delivered through Meta Quest 3® headset during dental procedure
cartoon video displayed in front of dental chair
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- no or slight anxiety
- high or severe anxiety
- visual disorders
- neuromuscular comorbidities interfering with cooperation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Ass. Oasi Maria SS
Troina, EN, 94018, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2025
First Posted
November 25, 2025
Study Start
February 1, 2025
Primary Completion
June 30, 2025
Study Completion
September 30, 2025
Last Updated
December 3, 2025
Record last verified: 2025-11