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

O

Oasi Research Institute-IRCCS

Status

Completed

Conditions

Intellectual Disabilities (F70-F79)

Treatments

Device: Control: Monitor-Based Distraction
Device: Virtual Reality Distraction - immersive VR software delivered through Meta Quest 3® headset during dental procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT07249359
RC-2794677

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

11 to 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

56 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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