The effect of virtual reality versus standard-of-care treatment on pain perception during paediatric vaccination: A randomised controlled trial.

The trial was single-centre and the children, parents, and vaccinating nurse were not blinded to the group. Pain and fear were self-reported immediately after the injection, and the same nurse who gave the vaccine also explained the scales and recorded data. Baseline fear was not measured, so changes in fear before and after the intervention are unknown. The fear question asked about fear during vaccination, but children may have answered with the whole process in mind. The Children's Fear Scale was not yet validated in Spanish. Nine children assigned to virtual reality did not use the headset because they refused or it failed, but they were analysed in the virtual reality group. The paper randomised 172 children and analysed 162, so results depend on intention-to-treat handling of losses. The sample size was adjusted for 30% losses, and no replacement participants were recruited. The control group used a bundle of standard distraction measures, including parent holding or physical contact, talking, books, musical toys, or videos on a parent's phone, so the contribution of any single control component cannot be separated. Heart rate did not show significant differences, so physiological support for the pain effect is limited.

The work was supported by grants from CEU Cardenal Herrera University for translation and from the Valencia University General Hospital Foundation, which were used for virtual reality equipment and design of the virtual experience. The authors declared no conflicts of interest.

Do not conclude that immersive virtual reality is safe for all children or that it replaces other pain-management strategies. Very young children and children with certain neurological or sensory problems were excluded, and some children refused or could not use the headset.