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NCT Number: NCT07667023

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.

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Key information

Conditions

Neurodevelopmental Disorder (Diagnosis) Autism Spectrum Disorder Child Development Disorders, Pervasive Disease Mental Disorders Neurodevelopmental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University

Budapest, 1088, Hungary

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality Headset

Device

Useing VR headset during dental treatments

standard dental care

Other

Standard dental treatments without VR headset

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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