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Abstract
Phlebotomy procedures required in food allergy (FA) diagnosis and clinical trials often induce fear and anxiety for pediatric patients. The primary aim of this study was to determine whether virtual reality (VR) applications were effective in reducing anxiety for pediatric FA patients undergoing phlebotomy during FA clinical trials. Secondary aims assessed fear, pain, procedural compliance, and adverse events. Participants undergoing phlebotomy were enrolled and randomized to a VR group or standard of care (SOC) group for this prospective pilot randomized, pragmatic study. Participants in the VR group played interactive applications on a customized Samsung Gear VR headset and those in the SOC group received the standard of care. Participants' anxiety, fear, and pain were assessed with the Children's Anxiety Meter, Children's Fear Scale, and FACES pain scale pre, during, and post phlebotomy procedure. Compliance was assessed using the modified Induction Compliance Checklist during the procedure and compared between two groups. Forty-nine participants were randomized to VR (n = 26) and SOC (n = 23) groups. Although both the VR and SOC groups experienced a decrease in anxiety and fear from pre- to post-procedure, those in the VR group experienced less anxiety and fear during the procedure than SOC participants. Similarly, both groups experienced an increase in pain from pre- to post-procedure; however, the VR group reported less pain during the procedure than SOC. Fewer symptoms of procedural non-compliance were reported in the VR group. Interactive VR applications may be an effective tool for reducing fear, anxiety, and pain during phlebotomy for FA clinical trials.
Highlights
Food allergies (FA) are increasingly prevalent globally [1], affecting up to 6% of children in the United States [2, 3]
Participants experienced a significant decrease of anxiety from pre- to post-procedure {time point effect coefficients [95% confidence interval (CI)]: from pre- to during-procedure: −0.43 (−1.32 to −0.45); pre- to postprocedure: −2.87 (−3.75 to −1.99); p < 0.001}, and this trend was similar in both virtual reality (VR) (p < 0.001) and standard of care (SOC) (p < 0.001) groups (Supplementary Table 2; Figure 1)
In a sample of pediatric patients undergoing phlebotomy for FA testing, immersive VR applications were an effective tool for reducing fear, anxiety, and pain during phlebotomy
Summary
Food allergies (FA) are increasingly prevalent globally [1], affecting up to 6% of children in the United States [2, 3]. While oral food challenge (OFC) is the “gold standard” for food allergy diagnoses, comprehensive diagnostic testing often requires skin prick testing or serum-specific immunoglobulin E (IgE) [4, 5]. Serum IgE testing requires phlebotomy, which often invokes fear and anxiety in children [6, 7]. In addition to diagnostic testing, frequent phlebotomy is requisite for many pediatric allergy clinical trials. Needle phobia is associated with treatment avoidance, nonadherence with vaccine schedules, and anticipatory unpleasant side effects [6, 11, 12]. Needle phobia may contribute to reluctance toward routine diagnostic testing and participation in FA trials that require phlebotomy
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