This is a prospective, randomized controlled, interventional therapy utilizing virtual
reality goggles as a method of distraction. Data will be collected during and after the
procedure on the type of behavior displayed and the child's response to standardized
questions. Pediatric patients aged 4-12 years who only require nitrous sedation to
complete painful dental treatment which necessitates anesthesia will be included in this
study. These patients exhibit Frankl 2-3 behavior, requiring behavior guidance in order
to complete the procedure. Frankl 1 or 4 children, those who do not need behavior
guidance at all, or children with heavy behavior guidance who would not be able to
complete the procedure, will be excluded.
Participants will be recruited in the clinic, during a new patient exam, routine hygiene
or operative dentistry appointment. Following the Frankl behavior score diagnosis, an
evaluation of behavior will happen during the beginning of the appointment, specifically
watching for acceptance of treatment plan, openness to conversation, and any defiant
behaviors or crying.
The parent and child being recruited for the study will be informed of the nature of the
study, the possible risks benefit and alternatives, and written consent will be obtained
from the parent or legal guardian. Assent from child 7 to 12 will also be required as
well. The qualifying patient will enter the operatory and be admitted into the study.
Participants will be briefed on how the study will proceed, and will be randomized into a
control group or treatment group. The groups will be selected at random prior to
treatment in the study. Both Groups will use of Faces, Legs, Arms, Crying
Consolability(FLACC) Scale, WongBaker FACES, and Houpt Behavior scales to access the pain
or discomfort of subjects. Patients will rate their pain using the Wong-Baker FACES Pain
Scale by indicating which face best depicts the pain they are experiencing. Each face has
a corresponding number: 0 = doesn't hurt at all to 10 = hurts as much as you can imagine.
Patients will be observed during injection and assessed by the operator using the Faces,
Legs, Arms, Crying Consolability (FLACC) scale. Each category will be rated from 0 to 2.
Zero indicating normal positions and no sign of discomfort and 2 indicating discomfort in
movements or unable to console/comfort. Patients will be observed during the procedure
using the Houpt Behavioral Scale. Each category is scored on the 0-2 scale which results
in a total score of 0-10. Assessment of Behavioral Score: 0 = Relaxed and comfortable,
1-3 = Mild discomfort, 4-6 = Moderate pain, 7-10 = Severe discomfort/pain.
Patients receiving N2O during their visit will follow the standard of care procedures.
The VR goggles will be placed on the head and in front of the eyes. Patients using the
goggles are automatically set to start media as soon as the wearer dons them. The patient
will be reclined, and placed in an ideal setting, and the goggles will be calibrated to
the patient's current view. The dental procedure will then follow. Most procedures
require a local anesthetic injection, and if the patient receives this injection,
participants will be graded with FLACC score during the injection. At the end of the
procedure the child will be evaluated using the Wong-Baker FACES scale, the Houpt Crying
and Movement Scales, and a survey will be given to the patient to be completed.
Participants will participate in the study during two restorative dental appointments,
however, some patients may need more than two visits. Participants who require multiple
restorative treatments will only being include in the study during first two visits and
no other research activities will occur after. Most appointments are projected to last a
maximum of 1 hour. The limiting factor in all treatment in this study, will be the
participant's willingness to participate in future appointments.