A Novel Clinician-Orchestrated Virtual Reality Platform for Distraction During Pediatric Intravenous Procedures in Children With Hemophilia: Randomized Controlled Trial.
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BACKGROUND Needles are frequently required for routine medical procedures Children with severe hemophilia require intensive intravenous IV therapy to treat and prevent life threatening bleeding and undergo hundreds of IV procedures Fear of needle related procedures may lead to avoidance of future health care and poor clinical outcomes Virtual reality VR is a promising distraction technique during procedures but barriers to commercially available VR platforms for pediatric health care purposes have prevented widespread use OBJECTIVE We hypothesized that we could create a VR platform that would be used for pediatric hemophilia care allow clinician orchestration and be safe and feasible to use for distraction during IV procedures performed as part of complex health care METHODS We created a VR platform comprising wireless adjustable disposable headsets and a suite of remotely orchestrated VR games The platform was customized for a pediatric hemophilia population that required hands free navigation to allow access to a child s hands or arms for procedures A hemophilia nurse observing the procedure performed orchestration The primary endpoint of the trial was safety Preliminary feasibility and usability of the platform were assessed in a single center randomized clinical trial from June to December 2016 Participants were children with hemophilia aged 6 18 years After obtaining informed consent 25 patients were enrolled and randomized Each subject 1 caregiver and 1 hemophilia nurse orchestrator assessed the degree of preprocedural nervousness or anxiety with an anchored combined modified visual analog VAS FACES scale Each participant then underwent a timed IV procedure with either VR or standard of care SOC distraction Each rater assessed the distraction methods using the 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 also rated how much they would like to use VR for future procedures To compare the length of procedure time between the groups Mann Whitney test was used RESULTS Of the 25 enrolled children 24 were included in the primary analysis No safety concerns or VR sickness occurred The median procedure time was 10 range 1 31 minutes in the VR group and was comparable to 9 range 3 20 minutes in the SOC group P 76 Patients in both the groups reported a positive influence of distraction on procedural anxiety and pain Overall in 80 34 45 of the VR evaluations children caregivers and nurses reported that they would like to use VR for future procedures CONCLUSIONS We demonstrated that an orchestrated VR environment could be developed and safely used during pediatric hemophilia care for distraction during IV interventions This platform has the potential to improve patient experience during medical procedures TRIAL REGISTRATION Clinical Trials gov NCT03507582 https clinicaltrials gov ct2 show NCT03507582 Archived by WebCite at http www webcitation org 73G75upA3