A Randomized Clinical Trial of a Novel Clinician Orchestrated Virtual Reality Platform for Distraction during Pediatric Intravenous Procedures in Children with Hemophilia (Preprint)
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Amy Dunn, Jeremy Patterson, Charmaine F Biega, Alice Grishchenko, John Luna, Joseph R. Stanek, Robert Strouse
2018
unpublished
BACKGROUND Introduction : Needles are frequently required for routine medical procedures. Children with severe hemophilia can have hundreds of IV procedures per year. Fear of needle related procedures can cause avoidance of future health care. Virtual reality (VR) has shown promise as a distraction technique during procedures, but barriers to commercially available VR platforms have prevented widespread use. OBJECTIVE Objective : We hypothesized that we could create a VR platform that would be
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... ustomized for pediatric hemophilia care, clinician orchestrated and feasible to use for distraction during intravenous (IV) procedures performed as a part of complex healthcare. METHODS Methods: We created a custom VR platform that consisted of a wireless, adjustable, disposable headset and a suite of VR games that could be orchestrated remotely. The platform was customized for a pediatric hemophilia population. Orchestration was performed by a hemophilia nurse observing the procedure. The primary endpoint of the trial was to assess feasibility of VR versus Standard-of-care (SOC) distraction during a planned IV procedure in the course of a comprehensive hemophilia clinic visit. Feasibility and usability of the platform was assessed in a single-center, randomized clinical trial from June through December 2016. Participants were children with hemophilia age 6 to 18 years. After informed consent 25 patients enrolled and were randomized. Each subject, 1 caregiver and 1 hemophilia nurse orchestrator assessed degree of pre-procedural nervousness/anxiety with an anchored, combined modified Visual Analog (VAS)/FACES scale prior to the IV procedure. Each participant then underwent a timed IV procedure with either VR or SOC distraction. Each rater assessed the distraction methods using a VAS/FACES scale at the completion of the IV procedure with questions targeting usability, engagement, impact on procedural anxiety, impact on procedural pain, and likability of the distraction technique. Participants, caregivers and nurses were also asked to rate how much they would like to use VR for future procedures. To compare the length of procedure time between the groups, the Mann-Whitney test was used. RESULTS Results: 25 children were enrolled and 24 were included in the primary analysis. The median procedure time was 10 minutes in the VR group (range 1-31 minutes) and was comparable to 9 minutes (range: 3-20 minutes) in the SOC arm (p=0. 764). Patients in both VR and SOC arms reported a positive influence of distraction on procedural anxiety and pain. Eighty percent of the children, caregivers and nurses reported that they would like to use VR for future procedures. No adverse events were experienced in either arm. CONCLUSIONS Conclusion: We demonstrated that an orchestrated, VR environment could be integrated and used during pediatric hemophilia care during IV interventions without adversely disrupting clinic flow. This platform has the potential to improve the patient experience during medical procedures. CLINICALTRIAL Clinical Trials.gov NCT03507582
doi:10.2196/preprints.10902
fatcat:im5acnm7jbdalmeph7lojm5biy