Effect of Virtual Reality Distraction on Perceived Pain During Dental Hygiene in Children With Mild Intellectual Disability

Effect of Virtual Reality Distraction on Perceived Pain During Dental Hygiene in Children With Mild Intellectual Disability: A Randomized Controlled Trial

The objective of this study was to evaluate whether the use of a virtual reality (VR) distractor reduces perceived pain during professional oral hygiene sessions in children with mild ID.

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Intellectual Disability
• Intervention / Treatment: Device: No distractor; Device: Virtual reality based distraction

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonio Fallea; Phone Number: 3381113255; Email: afallea@oasi.en.it

Study Locations

• Italy
  • EN
    • Troina, EN, Italy, 94018
      • Oasi Research Institute
      • Contact: Antonio Fallea; Phone Number: 3381113255; Email: afallea@oasi.en.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Moderate dental anxiety
• Mild intellectual disability
• Age between 5 and 7 years

Exclusion Criteria:

- Severe/low dental anxiety

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: No distractor	Device: No distractor; Dental treatment performed in inviduals without distractor device
Experimental: Virtual Reality Distraction	Device: Virtual reality based distraction; Dental polishing performed in individuals with VR device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain perception	Pain perception measured using the FLACC scale	25 minutes of dental hygiene treatment

Collaborators and Investigators

• Sponsor: Oasi Research Institute-IRCCS

Publications and helpful links

General Publications

• Fallea A, Costanza C, L'Episcopo S, Bartolone M, Rundo F, Smirni D, Roccella M, Elia M, Ferri R, Vetri L. Virtual Reality-Based Versus Traditional Teaching Approaches in the Oral Hygiene Education of Children with Autism Spectrum Disorder. J Clin Med. 2025 Aug 15;14(16):5795. doi: 10.3390/jcm14165795.

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): May 5, 2026
• Study Completion (Estimated): May 10, 2026

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RC-2794677 (medicina_new_sub)

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