Virtual Reality and Anxiety in Pediatric Dentistry
Condition: Pediatric Dentistry
Study type: Interventional

Summary: 
      Two groups of pediatric patients between the ages of 4 to 12 years old will be examined in
      this study. The treatment group will receive dental treatment while wearing Virtual reality
      Headset. Control group will receive the standard of care dental treatment with under nitrous
      sedation. Procedures performed in all groups will be restorative treatments, which can
      include intraoral anesthetic injections, placing dental fillings, crowns, and the extractions
      of teeth. In group 1, A specific VR headset, the "Oculus Quest 2" will be used. Through the
      headset, a video will be played for the child during a dental procedure.
    

Detailed description: 
      This is a 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.
      If the child had previously presented as Frankl 2-3 within 6 months of the day of screening,
      the child may be considered for the study.

      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,
      (continuing a typical procedure using nitrous oxide ), or treatment group (continuing a
      procedure with the VR goggles). The groups will be selected at random prior to treatment in
      the study, using the flip of a coin. Both Groups will use of FLACC, Wong-Baker FACES, and
      Houpt Behavior scales to access the pain or discomfort of subjects. The treatment group will
      have the goggles placed on the head and in front of the eyes. 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 a restorative dental appointment, however,
      some patients may need more the one restorative visit. Participants who require multiple
      restorative treatments will only being include in the study during one visit 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.
    

Intervention name(s): Virtual Reality Headset
Intervention type(s): Behavioral
Intervention description(s): To determine if virtual reality headsets can reduce a patients pain level instead of using the standard Nitrous. This may provide a alternate to patients who cannot receive nitrous if pain or anxiety can be reduced effectively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment