N/A
N=20
Virtual Reality in Pediatric Dentistry
Behavior, Child · Anxiety, Dental
Bottom Line
View on ClinicalTrials.gov: NCT05585905 ↗Enrolled (actual)
20
Serious AEs
—
Results posted
May 2026
Primary outcome: Primary: Beats Per Minute Change With VR — -2; -6.25; -8.8; -6.25 Beats per minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virtual Reality (Device); Basic Behavior Guidance Techniques (Behavioral)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beats Per Minute Change With VR |
-2; -6.25; -8.8; -6.25 | — |
| PRIMARY Beats Per Minute Change With BBG |
-2; -2.75; -3; -0.5 | — |
Summary
Dental Fear and Anxiety is an emotional experiences affecting many children and adolescents which can lead to behavioral problems in the dental setting. The purpose of the proposed study is to investigate the effect of virtual reality on anxiety, behavior, and pain in children undergoing restorative dental procedures. Children enrolled in the study will include patients ages 6-18 who are healthy and require two or more dental sealants (at least one sealant per side). The participants in the study will serve as their own control using a split-mouth cross-over randomized control clinical trial design and will be randomly assigned to receive virtual reality or traditional behavior guidance techniques first during dental sealant placement. The objectives of this study are to explore the associations between the use of virtual reality distraction during dental sealant placement with anxiety based on the change in heart rate, compared with to the control group. This model will include treatment, visit, treatment by visit interaction term as well as a treatment sequence variable. This is a pilot study. Data analyzed will be changed in heart rate between baseline and sealant placement using virtual reality or behavior guidance technique.. No statistical analysis will be conducted except mean and range.
Eligibility Criteria
Inclusion Criteria
- Age 6-18
- ASA I or II
- Present to the Herman Ostrow School of Dentistry Pediatric Dental Clinic and Children's Dental Health Clinic at Long Beach Memorial Hospital for an initial or periodic exam, and are determined to require two or more dental sealants (at least one sealant per half mouth)
Exclusion Criteria
Children with visual, auditory, or tactile deficits that would interfere with the ability to complete the experimental tasks
- Children who are unable to tolerate the RelievRx by AppliedVR will be screened after consenting to research participation by trying on the VR goggles and stating that they are comfortable and willing to proceed with wearing them during their dental appointment.
- Examples of children who may be unable to tolerate the VR goggles may include:
- Children who wear glasses and are unable to comfortably adjust the system over their glasses
- Children who experience dizziness, motion sickness or other discomfort during use
- Children who remove the VR goggles prior to dental sealant application
- Children who require pharmacological means to complete dental treatment (nitrous oxide, sedative drugs or general anesthesia)
- Children with a significant medical history of seizure disorders as flickering from devices can trigger epileptic episodes.
- Children with developmental disabilities
- Children with a psychiatric disorder, organic brain syndrome, mental retardation, or other known cognitive/neurological disorders
- Children that are not English or Spanish speaking
Data sourced from ClinicalTrials.gov (NCT05585905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.