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 ( n = 15) using VR and a control group ( n = 15) without VR during immunization. Feasibility was assessed by the response rate to the use of VR. The Faces Pain Scale-Revised (FPS-R) and the Children's Fear Scale (CFS) were used to determine their pain and anxiety, respectively. The anxiety level of their accompanying parents and attending nurses were evaluated using Visual Analog Scale (VAS) prior and post-immunization of these children. The FPS-R and CFS scores, and anxiety assessment for parents and nurses were assessed using Mann-Whitney U test. Wilcoxon signed rank test was used to assess the difference in the nurses' experience of using the VR application.
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; P = 0.04), parental VAS (median -4, IQR -5 to -1; P = 0.04) were significantly decreased. After immunization, nurses scored favorably for VR, in terms of simplicity (median 9.5, IQR 5.72 to 10; P = 0.01), acceptability (median 10, IQR 5 to 10; P = 0.005) and willingness to use VR in the future (median 10, IQR 5 to 10; P = 0.02).
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].
Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
(Copyright © 2022 Chang, Kang, Koh, Fong, Tang, Goh and Tan.)