Effect of Virtual Reality on children's pain perception during vaccination: pilot study of a randomized trial

Vaccination is an effective, available and reliable intervention that prevents infectious and debilitating diseases. However, it occurs more frequently in childhood, which can contribute to the development of trauma. Therefore, non-pharmacological interventions can be used to try to avoid this type of reaction, as virtual reality is one of them, as it allows the child to be immersed in a virtual, three-dimensional environment that provides distraction and reduces pain perception. Check feasibility of a pilot study of a randomized clinical trial on the effectiveness of immersive virtual reality glasses in terms of children's pain perception associated with intramuscular vaccination in relation to the traditional method. Pilot study of a randomized, controlled, parallel and open clinical trial, carried out in four vaccination units in Southern Brazil, between August and November 2023, with children between four and six years, 11 months and 29 days. The intervention group used immersive virtual reality glasses during the intramuscular vaccine, while the control group received the traditional clinical method, with both groups receiving the instructional therapeutic toy to prepare children during the vaccine. The association between the variables was verified using Pearson's chi-square test (X2) or Fisher's exact test with Confidence Intervals (CI) of 95%, and a significance level of 5% (p-value=0.05 ). Furthermore, the agreement between the pain reported by the child and the pain observed by the researcher and guardian was verified using Cohen's Kappa test. And, the criteria to test the feasibility of the protocol were: eligibility, recruitment, protocol fidelity; retention/friction; and, missing data, as well as the sample size was calculated. The study was approved by the Ethics Committee under opinion number 6,045,606. Of the 50 eligible participants, 48 ??were randomized and included in the final analysis, 23 children allocated to the intervention group and 25 to the control group. Furthermore, it was found that 17 (74%) children in the intervention group stated that they did not feel pain during the intramuscular vaccination using immersive virtual reality glasses, while only 6 (24%) children in the control group reported that they did not feel pain. However, there was no statistical difference when comparing the perception of severe pain reported by the children compared to the researcher's observation and the guardian's observation. Yelling and whining behavior were lower in the intervention group. In this pilot study there was a statistical difference between the groups in relation to pain reduction, since the control group had more severe pain, as well as the behaviors during the procedure were more intense.