The Effect of Virtual Reality on the Behavior of Pediatric Dental Patients During Dental Sealant Application.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- Change in behavior on the FRANKL Scale
Study Overview
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 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.
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 behavior, 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Virtual Reality (Device)
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.
Intervention: Basic Behavior Guidance Techniques (Behavioral)
Outcomes
Primary Outcomes
Change in behavior on the FRANKL Scale
Time Frame: Baseline, IImmediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques, and immediately after completion of dental treatment
Patient's behavior as rated by the dental provider within one of the following categories: 1= definitely negative, 2= negative, 3= positive, 4= definitely positive. This scale is routinely used by dentists and documented in the patient chart.
Change in anxiety
Time Frame: Baseline, Immediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques, and immediately after completion of dental treatment
Measured by change in heart rate (eg. beats per minute)
Change in behavior on the FLACCS scale
Time Frame: Baseline, Immediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques
Behavior Rating Score (FLACCS): Patient's behavior as rated by the FLACC behavioral pain scale. FLACC score includes facial expressions, leg movement, activity (bodily movement), crying, and consolability. Each category is score on the 0-2 scale resulting in a in a total score of 0-10. * 0 = Relaxed and comfortable * 1-3 = Mild discomfort * 4-6 = Moderate pain 12 * 7-10 = Severe discomfort/pain
Patient perceived pain
Time Frame: Immediately after sealant placement with Virtual Reality, Immediately after sealant placement with basic behavior guidance techniques
Patient's pain will be evaluated using the self-assessment Face Pain Scale- Revised (FPS-R) taken at outlined points (above) during restorative procedure. The FPS-R has 0-to-10 metric. The scale shows a close linear relationship with visual analog pain scales. Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so "0" equals "No pain" and "10" equals "Very much pain."
Secondary Outcomes
- Patient Satisfaction(5 minutes after the completion of treatment)
- Parent Satisfaction(5 minutes after the completion of treatment)
Investigators
Alexander Alcaaz
Principal Investigator
University of Southern California