Virtual Reality Headset as an Alternative Tool for Reducing Dental Anxiety

N/AEnrolling By InvitationNCT07667023

Semmelweis University200 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

200

Conditions

Neurodevelopmental Disorder (Diagnosis)

Interventions

Virtual reality headsetDEVICE

Useing VR headset during dental treatments

standard dental careOTHER

Standard dental treatments without VR headset

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Semmelweis University

Budapest, Hungary

Outcomes

Primary Outcomes

Change in Child Dental Anxiety via Venham Picture Scale (VPS)

The VPS is a self-report visual scale consisting of 8 pairs of drawings representing anxious and non-anxious children. The child selects the picture that best reflects their emotional state. Total score ranges from 0 (no anxiety) to 8 (maximum anxiety). Higher scores indicate higher anxiety.

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

Objective, physiological measurement of actual dental anxiety and stress response. Heart rate (measured in beats per minute) is used as an objective indicator for sympathetic nervous system arousal triggered by dental fear.

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 Outcomes

Change in Child Dental Anxiety via Facial Image Scale (FIS)

The FIS is a self-report scale comprising 5 faces ranging from very happy (score 1) to very unhappy (score 5). The child points to the face they feel most like at the moment. Higher scores indicate greater distress

Child Cooperation and Behavior via Frankl Behavior Rating Scale (FBRS)

The FBRS is a 4-point clinical rating scale used by the dentist to evaluate child cooperation. Scores range from 1 (definitely negative, refusal of treatment) to 4 (definitely positive, good rapport and enjoyment of the treatment). Higher scores indicate better cooperation.

Data from ClinicalTrials.gov

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