32 A randomized controlled trial of virtual reality-based distraction for intravenous cannulation-related distress in children

Abstract Background Children commonly experience under-treated pain and distress related to medical procedures, such as intravenous insertions (IVI), leading to both short- and long-term negative consequences for patients and their caregivers. Virtual reality (VR) has emerged as a promising tool to ameliorate procedure-related distress in the paediatric healthcare setting; however, existing evidence has largely employed custom VR software, which can be expensive and inaccessible. As such, we aimed to characterize whether commercially available VR applications are effective in reducing children’s procedure-related distress. Objectives To assess the effectiveness of commercially available VR-based distraction when added to standard of care (SOC, which included topical anesthetic cream), in reducing distress for children undergoing IVI in the paediatric emergency department (PED). Design/Methods Children aged 6 to 17 years requiring IVI in a Canadian PED were recruited for a two-arm randomized controlled trial. The primary outcome was child distress, measured using the Observational Scale of Behavioural Distress – Revised (OSBD-R, score range 0-23.5). Secondary outcomes included child pain intensity (measured with the Faces Pain Scale-Revised, score range 0-10) and caregiver anxiety [measured by the State-Trait Anxiety Inventory-State (STAI-S), score range 20-80] during the procedure. Trial registration number: NCT04291404C. Results 82 children and their caregivers were included. 41 children received VR distraction in addition to SOC (mean age 10.8 years, SD 3.0), while 41 children received SOC alone (mean age 11.3 years, SD 2.8). There was no significant difference between OSBD-R-measured distress in the VR arm (mean 1.05, SD 1.52) compared to the SOC arm (mean 0.71, SD 1.40) (p = 0.08). There was no significant reduction in procedural pain intensity in the VR group (mean 4.20,SD 3.10) compared to the SOC group (mean 4.10, SD 3.20) (p = 0.85). There was no difference in caregiver STAI-S score immediately following IVI in the VR arm (mean 32.3, SD 11.3) versus the SOC arm (mean 32.3, SD 11.9) (p = 0.86). Conclusion VR distraction therapy employing commercially available software was not associated with reduction in procedural distress or pain, above that provided with SOC in the PED, for children undergoing IVI. This result highlights the need for more accessible custom VR distraction software, created to meet the unique psychological needs of children undergoing medical procedures. Further study is needed to directly compare custom versus commercially available VR software for this application.

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