Mild Intellectual DisabilityNCT07503262
Effect of Virtual Reality Distraction on Perceived Pain During Dental Hygiene in Children With Mild Intellectual Disability
A study testing Virtual reality based distraction and No distractor in people with Mild Intellectual Disability, run by Oasi Research Institute-IRCCS at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Mild Intellectual Disability
- What is being tested?
- Virtual reality based distraction and No distractor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 20 Apr 2026to 10 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Moderate dental anxiety
- Mild intellectual disability
- Age between 5 and 7 years
Who cannot join
- Severe/low dental anxiety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Oasi Research Institute
Troina, EN, 94018
Antonio Fallea, 3381113255, afallea@oasi.en.it
About this study
Official title: 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.
- Conditions
- Mild Intellectual Disability
- Being tested
- Virtual reality based distraction, No distractor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality based distractionDevice
Dental polishing performed in individuals with VR device.
No distractorDevice
Dental treatment performed in inviduals without distractor device
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Distraction | Experimental | Not described Receives: Device: Virtual reality based distraction |
| No distractor | Active comparator | Not described Receives: Device: No distractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
Pain perception measured using the FLACC scale
Measured: 25 minutes of dental hygiene treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start20 Apr 2026 (estimated)
- Primary completion5 May 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oasi Research Institute-IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503262
- Sponsor's protocol ID
- RC-2794677 (medicina_new_sub)
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 40869621
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Distraction on Perceived Pain During Dental Hygiene in Children With Mild Intellectual Disability: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07503262
- Acronym / sponsor ID
- RC-2794677 (medicina_new_sub)
- Conditions
- Mild Intellectual Disability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Oasi Research Institute-IRCCSUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Distraction | Experimental | Device: Virtual reality based distraction |
| No distractor | Active comparator | Device: No distractor |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Moderate dental anxiety
- Mild intellectual disability
- Age between 5 and 7 years
Key exclusion criteria (1 listed)
- Severe/low dental anxiety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality based distractionDental polishing performed in individuals with VR device. | Device | Virtual Reality Distraction |
| No distractorDental treatment performed in inviduals without distractor device | Device | No distractor |
Primary outcome
Pain perception
Time frame: 25 minutes of dental hygiene treatment
Pain perception measured using the FLACC scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 40869621Fallea 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality based distraction and No distractor in people with Mild Intellectual Disability, run by Oasi Research Institute-IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Fallea (3381113255, afallea@oasi.en.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception (time frame: 25 minutes of dental hygiene treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07503262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.