Virtual Reality Headset as an Alternative Tool for Reducing Dental Anxiety

June 19, 2026 updated by: Semmelweis University

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

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children with special needs who wear VR headsets during dental treatment.
Device: Virtual reality headset
Useing VR headset during dental treatments
Active Comparator: Children with special needs who participate in dental treatment without VR headsets.
Other: standard dental care
Standard dental treatments without VR headset
Experimental: Typically developing children who wear VR headsets during dental treatment
Device: Virtual reality headset
Useing VR headset during dental treatments
Active Comparator: Typically developing children who participate in the study without using VR glasses.
Other: standard dental care
Standard dental treatments without VR headset

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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).
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.
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).
A 6-point clinical rating scale (ranging from 0 to 5) scored by the investigator to assess the child's state of anxiety and cooperative behavior based on specified objective behavioral criteria during dental care. A score of 0 represents a calm, relaxed state, while a score of 5 indicates extreme anxiety accompanied by the total refusal of dental treatment. Higher scores reflect greater anxiety and uncooperative behavior.
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).
A 4-item self-report questionnaire assessing general dental anxiety. Each item is scored on a 5-point scale. Total score ranges from 4 (no anxiety) to 20 (severe anxiety). Higher scores indicate higher levels of dental anxiety.
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).
A 20-item self-report questionnaire measuring a participant's denral fear. Items are scored on a 5-point scale. Total score ranges from 20 to 100. Higher scores indicate more negative beliefs and lower trust.
Immediately before dental examination (Session 1, Day 1) and within 5 minutes after restorative treatment (Session 3, Day 43).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2026

Primary Completion (Estimated)

January 31, 2031

Study Completion (Estimated)

January 31, 2031

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 24, 2026

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 19, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SE RKEB: 14/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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