Neurodevelopmental Disorder (Diagnosis)NCT07667023
Virtual Reality Headset as an Alternative Tool for Reducing Dental Anxiety
A study testing Virtual reality headset and standard dental care in people with Neurodevelopmental Disorder (Diagnosis), run by Semmelweis University at 1 site in Hungary.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorder (Diagnosis)
- What is being tested?
- Virtual reality headset and standard dental care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteHungary
- Study dates
- 12 Jun 2026to 31 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages 6-12
- At least one decayed primary tooth
- A consent form signed voluntarily by a parent or legal guardian after receiving information
Who cannot join
- The patient or legal guardian refuses to participate in the study.
- A patient who is completely uncooperative
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Neurodevelopmental Disorder (Diagnosis)
- Being tested
- Virtual reality headset, standard dental care
- Keywords
- autism spectrum disorder, dental anxiety, child, pediatric dentistry
- Medical subject headings
- Neurodevelopmental Disorders, Disease, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
Useing VR headset during dental treatments
standard dental careOther
Standard dental treatments without VR headset
| Study group | Role | What they receive |
|---|---|---|
| Children with special needs who wear VR headsets during dental treatment. | Experimental | Not described Receives: Device: Virtual reality headset |
| Children with special needs who participate in dental treatment without VR headsets. | Active comparator | Not described Receives: Other: standard dental care |
| Typically developing children who wear VR headsets during dental treatment | Experimental | Not described Receives: Device: Virtual reality headset |
| Typically developing children who participate in the study without using VR glasses. | Active comparator | Not described Receives: Other: standard dental care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Immediately before dental examination (Session 1, Day 1) and within 5 minutes after restorative treatment (Session 3, Day 43).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start12 Jun 2026
- Primary completion31 Jan 2031 (estimated)
- Study completion31 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental Disorder (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667023
- Sponsor's protocol ID
- SE RKEB: 14/2026
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Care for Children With Special Needs - Virtual Reality Headset as an Alternative Tool for Reducing Dental Anxiety
- ClinicalTrials.gov ID
- NCT07667023
- Acronym / sponsor ID
- SE RKEB: 14/2026
- Conditions
- Neurodevelopmental Disorder (Diagnosis)
- Keywords
- autism spectrum disorder, dental anxiety, child, pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 31 Jan 2031 (estimated)
- Study completion
- 31 Jan 2031 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 6-12
- At least one decayed primary tooth
- A consent form signed voluntarily by a parent or legal guardian after receiving information
Key exclusion criteria (2 listed)
- The patient or legal guardian refuses to participate in the study.
- A patient who is completely uncooperative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality headsetUseing VR headset during dental treatments | Device | Children with special needs who wear VR headsets during dental treatment., Typically developing children who wear VR headsets during dental treatment |
| standard dental careStandard dental treatments without VR headset | Other | Children with special needs who participate in dental treatment without VR headsets., Typically developing children who participate in the study without using VR glasses. |
Primary outcome
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.
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.
5 secondary outcomes
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).
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset and standard dental care in people with Neurodevelopmental Disorder (Diagnosis), run by Semmelweis University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.