Dental AnxietyVR-DENT-PEDNCT07857408
Virtual Reality Audiovisual Distraction During Pediatric Dental Treatment
A study testing Audiovisual distraction using virtual reality glasses in people with Dental Anxiety and Dental Fear, run by Universidad Europea de Madrid at 1 site in Spain.
Trial summary
Dental anxiety is common in children and may interfere with cooperation during dental treatment. Audiovisual distraction using virtual reality glasses may help redirect attention away from dental stimuli and improve the patient experience. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Dental Anxiety, Dental Fear, Pediatric Dentistry
- What is being tested?
- Audiovisual distraction using virtual reality glasses
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2022to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 6 to 17 years.
- Patients attending the Dental Clinic of Universidad Europea de Madrid for dental treatment.
- Written informed consent provided by parents or legal guardians.
- Child assent/information provided according to age and level of understanding.
Who cannot join
- Absence of written informed consent from parents or legal guardians.
- Visual or auditory impairment preventing the use of audiovisual distraction.
- Medical conditions contraindicating dental treatment in the clinical setting.
- Behavioral management not feasible in the clinical setting.
- In the virtual reality group, discontinuation of the intervention by removing the glasses during treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Audiovisual Distraction Using Virtual Reality Glasses for Reducing Anxiety During Pediatric Dental Treatment: A Prospective Non-Randomized Controlled Clinical Study
Dental anxiety is common in children and may interfere with cooperation during dental treatment. Audiovisual distraction using virtual reality glasses may help redirect attention away from dental stimuli and improve the patient experience.
This completed prospective non-randomized controlled clinical study evaluated the effect of virtual reality audiovisual distraction on anxiety-related variables in pediatric patients undergoing dental treatment at the Dental Clinic of Universidad Europea de Madrid. Participants received either standard dental care without audiovisual distraction or standard dental care while using virtual reality glasses during the procedure.
Dental anxiety was assessed using the Modified Facial Image Scale. Heart rate and peripheral oxygen saturation were recorded using pediatric pulse oximetry. Behavioral response was assessed using the FLACC scale. Measurements were taken before, during, and after dental treatment; in the virtual reality group, additional measurements were collected while the child was using the glasses and after the glasses were removed. This record was submitted after completion of participant enrollment and data collection for retrospective public registration.
Read the detailed description
This study was conducted in pediatric patients aged 6 to 17 years who attended the Dental Clinic of Universidad Europea de Madrid and required dental treatment. Patients were assigned to one of two clinical conditions: standard dental care without audiovisual distraction or standard dental care with audiovisual distraction using virtual reality glasses. The virtual reality glasses reproduced narrative audiovisual content intended to distract the child from the dental procedure and reduce anxiety-related responses.
The dental procedures included prophylaxis, topical fluoride application, pit and fissure sealants, and restorative dental treatment. All dental procedures were performed by dental students under direct supervision of calibrated clinical instructors with experience in pediatric dentistry. Operators and investigators received specific training in the use of the anxiety and behavioral assessment scales and in the recording of physiological variables.
The primary outcome was dental anxiety assessed using the Modified Facial Image Scale. Secondary outcomes included heart rate, peripheral oxygen saturation, and behavioral response using the FLACC scale. Measurements were recorded at predefined time points during the dental visit. The final analytical sample consisted of 79 participants; however, actual enrollment was 81 because two participants in the virtual reality group discontinued the intervention by removing the glasses during treatment.
- Conditions
- Dental Anxiety, Dental Fear, Pediatric Dentistry
- Being tested
- Audiovisual distraction using virtual reality glasses
- Keywords
- Virtual Reality, Audiovisual distraction, Pediatric Dentistry, Dental anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual distraction using virtual reality glassesBehavioural
Use of virtual reality glasses during pediatric dental treatment to provide immersive audiovisual distraction and redirect attention away from dental stimuli.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Audiovisual Distraction | Experimental | Participants received standard pediatric dental treatment while wearing virtual reality glasses that reproduced narrative audiovisual content during the procedure. Receives: Behavioral: Audiovisual distraction using virtual reality glasses |
| Standard Dental Care | No intervention | Participants received standard pediatric dental treatment under usual clinical conditions without additional audiovisual distraction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dental anxiety assessed using the Modified Facial Image Scale
Dental anxiety was measured using the Modified Facial Image Scale, a child-friendly facial scale used to assess self-perceived emotional state in pediatric dental settings. Higher scores indicate greater anxiety or a more negative emotional response.
Measured: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
Secondary outcomes (3)
Change in heart rate during pediatric dental treatment
Heart rate was recorded using pediatric pulse oximetry and expressed in beats per minute.
Measured: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
Change in peripheral oxygen saturation during pediatric dental treatment
Peripheral oxygen saturation was recorded using pediatric pulse oximetry and expressed as SpO2 percentage.
Measured: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
Behavioral response assessed using the FLACC scale
Behavioral response was assessed using the FLACC scale, which evaluates Face, Legs, Activity, Cry, and Consolability. The total score ranges from 0 to 10, with higher scores indicating greater behavioral distress or discomfort.
Measured: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start10 Oct 2022
- Primary completion15 Apr 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Adanero Velasco, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857408
- Sponsor's protocol ID
- CIPI-22-306
- Acronym
- VR-DENT-PED
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the study involved pediatric participants and the dataset contains potentially sensitive clinical information. De-identified aggregated data or additional information may be available from the corresponding author upon reasonable request and subject to institutional and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiovisual Distraction Using Virtual Reality Glasses for Reducing Anxiety During Pediatric Dental Treatment: A Prospective Non-Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07857408
- Acronym / sponsor ID
- VR-DENT-PED / CIPI-22-306
- Conditions
- Dental Anxiety, Dental Fear, Pediatric Dentistry
- Keywords
- Virtual Reality, Audiovisual distraction, Pediatric Dentistry, Dental anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 5 Oct 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.
Dental anxiety is common in children and may interfere with cooperation during dental treatment. Audiovisual distraction using virtual reality glasses may help redirect attention away from dental stimuli and improve the patient experience.
This completed prospective non-randomized controlled clinical study evaluated the effect of virtual reality audiovisual distraction on anxiety-related variables in pediatric patients undergoing dental treatment at the Dental Clinic of Universidad Europea de Madrid. Participants received either standard dental care without audiovisual distraction or standard dental care while using virtual reality glasses during the procedure.
Dental anxiety was assessed using the Modified Facial Image Scale. Heart rate and peripheral oxygen saturation were recorded using pediatric pulse oximetry. Behavioral response was assessed using the FLACC scale. Measurements were taken before, during, and after dental treatment; in the virtual reality group, additional measurements were collected while the child was using the glasses and after the glasses were removed. This record was submitted after completion of participant enrollment and data collection for retrospective public registration.
Detailed description
This study was conducted in pediatric patients aged 6 to 17 years who attended the Dental Clinic of Universidad Europea de Madrid and required dental treatment. Patients were assigned to one of two clinical conditions: standard dental care without audiovisual distraction or standard dental care with audiovisual distraction using virtual reality glasses. The virtual reality glasses reproduced narrative audiovisual content intended to distract the child from the dental procedure and reduce anxiety-related responses.
The dental procedures included prophylaxis, topical fluoride application, pit and fissure sealants, and restorative dental treatment. All dental procedures were performed by dental students under direct supervision of calibrated clinical instructors with experience in pediatric dentistry. Operators and investigators received specific training in the use of the anxiety and behavioral assessment scales and in the recording of physiological variables.
The primary outcome was dental anxiety assessed using the Modified Facial Image Scale. Secondary outcomes included heart rate, peripheral oxygen saturation, and behavioral response using the FLACC scale. Measurements were recorded at predefined time points during the dental visit. The final analytical sample consisted of 79 participants; however, actual enrollment was 81 because two participants in the virtual reality group discontinued the intervention by removing the glasses during treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Audiovisual Distraction | Experimental | Behavioral: Audiovisual distraction using virtual reality glassesParticipants received standard pediatric dental treatment while wearing virtual reality glasses that reproduced narrative audiovisual content during the procedure. |
| Standard Dental Care | No intervention | –Participants received standard pediatric dental treatment under usual clinical conditions without additional audiovisual distraction. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pediatric patients aged 6 to 17 years.
- Patients attending the Dental Clinic of Universidad Europea de Madrid for dental treatment.
- Written informed consent provided by parents or legal guardians.
- Child assent/information provided according to age and level of understanding.
Key exclusion criteria (5 listed)
- Absence of written informed consent from parents or legal guardians.
- Visual or auditory impairment preventing the use of audiovisual distraction.
- Medical conditions contraindicating dental treatment in the clinical setting.
- Behavioral management not feasible in the clinical setting.
- In the virtual reality group, discontinuation of the intervention by removing the glasses during treatment.
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 |
|---|---|---|
| Audiovisual distraction using virtual reality glassesUse of virtual reality glasses during pediatric dental treatment to provide immersive audiovisual distraction and redirect attention away from dental stimuli. | Behavioural | Virtual Reality Audiovisual Distraction |
Primary outcome
Change in dental anxiety assessed using the Modified Facial Image Scale
Time frame: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
Dental anxiety was measured using the Modified Facial Image Scale, a child-friendly facial scale used to assess self-perceived emotional state in pediatric dental settings. Higher scores indicate greater anxiety or a more negative emotional response.
3 secondary outcomes
Change in heart rate during pediatric dental treatment
Time frame: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
Change in peripheral oxygen saturation during pediatric dental treatment
Time frame: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
Behavioral response assessed using the FLACC scale
Time frame: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the study involved pediatric participants and the dataset contains potentially sensitive clinical information. De-identified aggregated data or additional information may be available from the corresponding author upon reasonable request and subject to institutional and ethical restrictions.
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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. This study is not recruiting at the moment.
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 Audiovisual distraction using virtual reality glasses in people with Dental Anxiety and Dental Fear, run by Universidad Europea de Madrid at 1 site in Spain.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 5 Oct 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 dental anxiety assessed using the Modified Facial Image Scale (time frame: Baseline before dental treatment, Perioprative: during dental treatment, Immediately after dental treatment. In the virtual reality arm: Baseline before dental treatment Perioperative: while using the glasses After treatment; after removal.). 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 5 Oct 2026.