Immersive Virtual Reality in Alleviating Pain and Anxiety in Children During Immunization in Primary Care: A Pilot Randomized Controlled Trial.

Background: Pediatric immunization is often associated with significant fear and anxiety among the children and their parents. Their distress may potentially affect their adherence to the childhood immunization schedule and the acceptance of other recommended vaccines by physicians. Objective: The study primarily aimed to assess the feasibility of using immersive virtual reality (VR) during immunization in children in primary care. The secondary aim was to determine the effectiveness of immersive VR in alleviating pain and anxiety among children, reduction of anxiety of their parents and attending nurses during immunization compared to usual care without VR. Methods: A pilot open-label randomized control trial was conducted at a public primary care clinic in Singapore. Thirty children, aged 4-10 years were randomized to an intervention group ( Results: One child refused to use the VR equipment, constituting a rejection rate of 6.7% (1/15) but no adverse event occurred in the intervention arm. The overall response rate of 88% (30/34) when the parents were approached to participate in the study, indicating feasibility of using VR in childhood immunization. In the intervention group compared to the control group, the change in scores for CFS (median -1, IQR -2 to 0; Conclusion: Immersive VR is feasible, safe and effective in alleviating anxiety among the children and parents. Nurses viewed the application of VR in childhood immunization favorably. Clinical Trial Registration: [https://clinicaltrials.gov/ct2/show/NCT04748367], identifier [NCT04748367].