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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings