Virtual Reality Pediatric Orthopaedic Outpatient Procedures
Condition: Anxiety; Pain
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The main objective of the study is to evaluate the use of Virtual Reality (VR) in managing
      pain and anxiety levels during common pediatric orthopaedic outpatient procedures which
      include: cast application, cast removal, hardware removal (ie. pins and screws), and botox
      injections.
    

Detailed description: 
      Immediately following recruitment, demographic data and diseased related information (ie.
      location of cast/hardware, reason for cast/hardware placement and location and reason for
      botox injection) will be collected through self and/or guardian report. All data will be
      collected using REDCap (research electronic data capture). Using a parallel group design,
      patients will then be stratified by age (4-7, 8-12 and 13-18 years), gender, and procedure
      classifications (hardware or cast or staple or suture removal or cast application or botox
      injection) site of hardware or cast or staple or suture or botox injection), and reason for
      the procedure (trauma vs a preexisting orthopaedic condition). After randomization by the
      REDCap system, patients are taken into the procedure room where a questionnaire (Short STAI)
      is completed by the patient to collect pre-procedural state anxiety measurements. Following
      this, patients in the control group will receive standard of care (SOC) which allows for the
      technician and/or accompanying guardian to try and distract and or console the patient as
      they normally would. The patients in the intervention group will receive SOC with Virtual
      Reality (VR) interaction a few minutes before, during and following the procedure (around
      5-10minutes total). During the procedure the researcher will complete an observational survey
      (CEMS) to assess procedural state anxiety. Upon completion, both groups will then be asked to
      complete a survey (Short STAI) to collect post-procedural anxiety levels and an additional
      survey (Wong Baker Scale) to retrospectively collect pain levels from during the procedure
      and their current pain levels post procedure while parent/guardians and cast technician will
      be asked to complete their respective satisfaction questionnaires. Following this, the child
      will be asked if they experienced any nausea at any point during the procedure, if they did,
      they will be asked to complete the BARF questionnaire to measure the amount of nausea
      experienced. Following completion of questionnaires, patients who were in the control group
      are invited to interact with the VR simulation for a total of 5 minutes. This was chosen to
      incentivize recruitment for the study.

      SOC will consist of the technician/care provider explaining the procedure while using speech
      to be comforting and supportive in addition to parent/guardians being allowed to console and
      distract their child during the procedure.
    

Intervention name(s): Virtual Reality
Intervention type(s): Device
Intervention description(s): A calming virtual reality game will be played
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care