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VR or softer settings: which calms anxious kids at the dentist?

NCT ID NCT07261670

Symptom relief Sponsor: Oasi Research Institute-IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two ways to reduce dental anxiety in 98 children aged 10-13 with borderline intellectual functioning. One group used a virtual reality headset during dental treatment, while the other experienced a sensory-adapted environment with dim lights and quiet tools. The goal was to see which helped more children complete a filling within 30 minutes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Virtual reality headset and sensory-adapted dental environment
What this could lead to
If successful, this could point toward simple, non-drug ways to help children with borderline intellectual functioning feel calmer during dental visits.
What could go wrong
This is a small, completed study with 98 participants. Results may not apply to other age groups or settings, and neither approach may work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

98 people

The number who actually took part.

Started

Jun 2025

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

11 to 13 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * age of participants between 10 and 13 years * Diagnosis of Borderline Intellectual Func-tioning (BIF) confirmed by experienced neuropsychiatrists according to DSM-5 criteria * Moderate dental anxiety, defined by a DAS score between 9 and 12 * Presence of at least one tooth with a Class I carious lesion requiring restorative treatment Exclusion Criteria: * absence of dental anxiety (DAS score = 4) * the presence of mild anxiety (DAS score = 5-8) * high or severe anxiety (DAS score ≥ 13)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Borderline intellectual functioning (BIF)

Contacts and locations

Locations

  • IRCCS Ass. Oasi Maria SS

    Troina, EN, 94018, Italy

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