Virtual Reality in Pediatric Dentistry

NCT ID: NCT05585905

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-17
• Study Completion Date: 2024-06-30

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.

Conditions

Behavior, Child; Anxiety, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality

The virtual reality system being used for research purposes is the RelievRx by AppliedVR which is an immersive virtual reality device that includes a goggle headset and remote control. 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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: DEVICE

The VR system will be worn for approximately 5-10 minutes during dental sealant application

Basic Behavior Guidance Techniques

The control sample will include basic behavior guidance techniques and is standard of care. The use of basic behavior guidance techniques is common in pediatric dentistry and is not unique to this study.

Group Type: ACTIVE_COMPARATOR

Basic Behavior Guidance Techniques

Intervention Type: BEHAVIORAL

Basic behavior guidance techniques will be used as a distraction technique when the VR system is not used during the dental sealant application

Interventions

Virtual Reality

The VR system will be worn for approximately 5-10 minutes during dental sealant application

Intervention Type: DEVICE

Basic Behavior Guidance Techniques

Basic behavior guidance techniques will be used as a distraction technique when the VR system is not used during the dental sealant application

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Alexander Alcaaz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carla Angela Alvarez, DMD

Role: STUDY_CHAIR

Herman Ostrow School of Dentistry Pediatric Department

Locations

Children's Dental Health Clinic

Long Beach, California, United States

Herman Ostrow School of Dentistry Pediatric Department

Los Angeles, California, United States

Countries

United States

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Other Identifiers

UP-21-00583

Identifier Type: -

Identifier Source: org_study_id