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NCT Number: NCT07473479

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.

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Key information

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oasi IRCCS Research Institute

Troina, Enna, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Severe/low dental anxiety

Treatment and study plan

Professional oral hygiene session

Device

Dental polishing performed in individuals with VR device

No distractor

Device

Dental treatment performed in inviduals without distractor device

Primary outcomes

  1. Pain perception

    Time frame: 25 minutes of dental hygiene treatment

    Pain perception measured using the FLACC scale

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Fallea

CONTACT

[email protected]

+393381113255

Sponsors and collaborators

Lead sponsor

Oasi Research Institute-IRCCS

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 30, 2026

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.

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