Virtual Reality Audiovisual Distraction During Pediatric Dental Treatment (VR-DENT-PED)
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Madrid
-
Madrid, Madrid, Spanje, 28003
- Policlinica Universitaria UEM
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Virtual Reality Audiovisual Distraction
Participants received standard pediatric dental treatment while wearing virtual reality glasses that reproduced narrative audiovisual content during the procedure. |
Use of virtual reality glasses during pediatric dental treatment to provide immersive audiovisual distraction and redirect attention away from dental stimuli. |
|
Geen tussenkomst: Standard Dental Care
Participants received standard pediatric dental treatment under usual clinical conditions without additional audiovisual distraction. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in dental anxiety assessed using the Modified Facial Image Scale
Tijdsspanne: 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. |
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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in heart rate during pediatric dental treatment
Tijdsspanne: 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.
|
Heart rate was recorded using pediatric pulse oximetry and expressed in beats per minute. |
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
Tijdsspanne: 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.
|
Peripheral oxygen saturation was recorded using pediatric pulse oximetry and expressed as SpO2 percentage. |
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
Tijdsspanne: 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 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. |
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.
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- CIPI-22-306
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .