Virtual Reality Headset as an Alternative Tool for Reducing Dental Anxiety

NCT07667023 | Enrolling By Invitation

• 1 other identifier: SE RKEB: 14/2026
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurodevelopmental Disorder (Diagnosis)

Keywords

autism spectrum disorder; dental anxiety; child; pediatric dentistry

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 (5)

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

  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)

  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)

  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)

  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)

  Immediately before dental examination (Session 1, Day 1) and within 5 minutes after restorative treatment (Session 3, Day 43).

Study Arms (4)

Children with special needs who wear VR headsets during dental treatment.

EXPERIMENTAL

Device: Virtual reality headset

Children with special needs who participate in dental treatment without VR headsets.

ACTIVE COMPARATOR

Other: standard dental care

Typically developing children who wear VR headsets during dental treatment

EXPERIMENTAL

Device: Virtual reality headset

Typically developing children who participate in the study without using VR glasses.

ACTIVE COMPARATOR

Other: standard dental care

Interventions

Virtual reality headset DEVICE

Useing VR headset during dental treatments

Children with special needs who wear VR headsets during dental treatment.; Typically developing children who wear VR headsets during dental treatment

standard dental care OTHER

Standard dental treatments without VR headset

Children with special needs who participate in dental treatment without VR headsets.; Typically developing children who participate in the study without using VR glasses.

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University

Budapest, 1088, Hungary

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders; Disease; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Child Development Disorders, Pervasive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 24, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): January 31, 2031
• Study Completion (Estimated): January 31, 2031
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)