Clinical trial NCT05585905: Virtual Reality in Pediatric Dentistry
Official title: The Effect of Virtual Reality on the Behavior of Pediatric Dental Patients During Dental Sealant Application.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavior, Child
Anxiety, Dental
Keywords: Virtual Reality
Dental
Local Anesthesia
Nitrous Oxide
Anxiety
Pain
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 Frankl score, FLACC scale, and anxiety based on the change in heart rate, and pain based on self-reported FPS-R when compared with to the control group. The crossover design will be assessed by a linear mixed model with patient treated as a random effect. This model will include treatment, visit, treatment by visit interaction term as well as a treatment sequence variable. Prior to analysis, the primary outcome measures will be assessed for normality using a Shapiro-Wilk statistic as well as quantile-quantile (QQ) plots. Should the data deviate sharply from a normal distribution, normalizing transformations will be sought and applied to the data.

Detailed description: This study is a randomized controlled trial with a crossover design. Patients who are visiting the clinic for a comprehensive or periodic dental exam and are found to require two or more dental sealants (at least one sealant per side). The study subjects will include children ages 6-18 who are ASA I or II, as defined by the American Society of Anesthesiologists classification system. The proposed sample size for the study is 40 participants.

The children who are enrolled in the study will serve as both the experimental group and their own control. This is a split mouth design in which children who are enrolled in the study will serve as both the experimental group and their own control. After the child and parent are scheduled for the dental sealant appointment, they will be randomly assigned to receive the virtual reality system as a distraction technique for the first half or the latter half of the appointment (for research purposes). During the time when virtual reality is not used, traditional basic behavior guidance techniques will be used, as is the standard of care.

The virtual reality system being used for research purposes is the RelieVR by Applied VR which includes the goggle headset only. The VR experience will be an immersive experience where the child will interact with the system and navigate their way through a game that will involve bright colors, cartoon-like characters and settings with age-appropriate content. The VR system will be worn for approximately 5-10 minutes during the dental sealant application.

The dental sealant appointment will be video recorded, for research purposes and data collection. The video camera will be placed to include the child's face in order to monitor their facial expressions, legs movement, and activity during the administration of local anesthesia. The video camera will also be placed to include the blood pressure monitor and heart rate readings.

The behavior, pain, and anxiety will be analyzed at specific steps of the procedure including:

* Baseline (patient sitting in the chair prior to treatment)
* During sealant placement with Virtual Reality distraction
* During sealant placement with basic behavior guidance techniques
* Post Operative (patient sitting upright in chair, 5 minutes after procedure)

The Face, Legs, Activity, Cry, Consolability (FLACC) scale is a behavioral pain scale that will be conducted at the previously mentioned time intervals.

The patient's anxiety will be evaluated with a change in heart rate.

Additionally, at the end of each appointment for the duration of the study, the provider will assign the patient a Frankl behavior score 1-5, and record it in the patient's chart, as is the standard of care. The provider will also complete a Healthcare Provider Questionnaire through Qualtrics.

Data will be analyzed statistically to assess the relationship between a child's behavior (measured by the Frankl score and FLACCS scale), pain (measured by FPS-R), and anxiety (measured by heart rate) with the use of virtual reality or basic behavior guidance techniques.

The demographic factors will be collected from the patient's medical chart. The parent will be asked "how many hours of "screen time" (TV, computer, video games, tablet use), would you say that your child is allowed per week?". Parents and patients will also be asked to complete a satisfaction survey post-treatment.

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

Primary outcomes:
measure: Change in behavior on the FLACCS scale
timeFrame: Baseline, Immediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques
measure: Change in behavior on the FRANKL Scale
timeFrame: Baseline, IImmediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques, and immediately after completion of dental treatment
measure: Change in anxiety
timeFrame: Baseline, Immediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques, and immediately after completion of dental treatment
measure: Patient perceived pain
timeFrame: Immediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques
Secondary outcomes:
measure: Parent Satisfaction
timeFrame: 5 minutes after the completion of treatment
measure: Patient Satisfaction
timeFrame: 5 minutes after the completion of treatment
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Children's Dental Health Clinic
state: California
city: Los Angeles
country: United States
facility: Herman Ostrow School of Dentistry Pediatric Department
state: California
Study officials:
affiliation: Herman Ostrow School of Dentistry Pediatric Department
name: Carla Angela Alvarez, DMD
role: STUDY_CHAIR
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