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Enrolling by invitation NCT07667023

Virtual Reality Headset as an Alternative Tool for Reducing Dental Anxiety

No phase Interventional Neurodevelopmental Disorder (Diagnosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual reality headset, standard dental care.
Who it may be relevant to
Registry conditions: Neurodevelopmental Disorder (Diagnosis). Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Dental Care for Children With Special Needs - Virtual Reality Headset as an Alternative Tool for Reducing Dental Anxiety

Overview

The aim of this study is to investigate whether the use of virtual reality (VR) headsets can have a positive effect on dental fear during dental procedures and stress induced by the dental environment. Particular attention is paid to children with mild intellectual disabilities and those living with neurodevelopmental disorders (autism spectrum disorder), for whom these factors may hinder the successful completion of procedures.

Interventions

  • Device Virtual reality headset
    Useing VR headset during dental treatments
  • Other standard dental care
    Standard dental treatments without VR headset

Primary outcome measures

  • Change in Child Dental Anxiety via Venham Picture Scale (VPS) [Time frame: Evaluated at 6 specific time points: immediately before and within 5 minutes after the dental examination (Session 1, Day 1), the oral hygiene treatment (Session 2, Day 22), and the restorative treatment (Session 3, Day 43).]
  • Physiological Manifestation of Dental Anxiety via Pulse Rate [Time frame: Continuously monitored (every 4 seconds) during each procedure: dental examination (Session 1, Day 1), oral hygiene treatment (Session 2, Day 22), and restorative treatment (Session 3, Day 43)]
Secondary outcome measures (5)
  • Change in Child Dental Anxiety via Facial Image Scale (FIS) [Time frame: Evaluated at 6 specific time points: immediately before and within 5 minutes after the dental examination (Session 1, Day 1), the oral hygiene treatment (Session 2, Day 22), and the restorative treatment (Session 3, Day 43).]
  • Child Cooperation and Behavior via Frankl Behavior Rating Scale (FBRS) [Time frame: Evaluated within 5 minutes after the completion of each active procedure and reported for each session: dental examination (Session 1, Day 1), oral hygiene treatment (Session 2, Day 22), and restorative treatment (Session 3, Day 43).]
  • Clinical Evaluation of Behavior via Venham Anxiety and Behavior Scale (VABS) [Time frame: Evaluated within 5 minutes after the completion of each active procedure and reported for each session: dental examination (Session 1, Day 1), oral hygiene treatment (Session 2, Day 22), and restorative treatment (Session 3, Day 43).]
  • Change in Dental Anxiety via Dental Anxiety Scale (DAS) [Time frame: Immediately before dental examination (Session 1, Day 1) and within 5 minutes after restorative treatment (Session 3, Day 43).]
  • Change in Dental Fear via Dental Fear Survey (DFS) [Time frame: Immediately before dental examination (Session 1, Day 1) and within 5 minutes after restorative treatment (Session 3, Day 43).]

Eligibility criteria

Inclusion criteria

  • Ages 6-12
  • At least one decayed primary tooth
  • A consent form signed voluntarily by a parent or legal guardian after receiving information

Exclusion criteria

  • The patient or legal guardian refuses to participate in the study.
  • A patient who is completely uncooperative

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Hungary · 1 center
  • Semmelweis University — Budapest

Identifiers

NCT: NCT07667023 · SE RKEB: 14/2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗