Effectiveness of non-immersive virtual reality in the management of procedure-related pain in preschool children: a randomized clinical trial

The objective of this study is to assess the effectiveness of non-immersive virtual reality as a pain-distraction measure in children between the ages of 3 and 5 years undergoing painful injection procedures in an outpatient setting. We carried out a randomized, unmasked clinical trial in children undergoing venipuncture or intramuscular injection procedures. Patients were randomized to a distraction virtual reality video or standard care. After the procedure, three independent observers (parents, researchers, nursing staff) rated pain on the LLANTO pain scale. We recruited 122 subjects, half of which were randomized to virtual reality. The median age was of approximately 60 months (IQR: 15 months), and the sample was balanced with regard to sex. There were significant differences in LLANTO scales scores between the VR subjects and controls of − 3.34 (95% CI − 4.15; − 2.54), − 3.02 (95% CI − 3.90; − 2.14), and − 2.98 (95% CI − 3.87; − 2.09), as rated by parents, researchers, and nursing staff, respectively. Agreement between raters was high for all three types of observers, with Cohen Kappas over 0.79 in all cases. Bivariate analysis showed reductions in the risk of obtaining higher scores in the LLANTO scale. Linear regression models showed a reduction of approximately 3 points in the scale, regardless of the type of observer. These models were adjusted for sex, age, kind of procedure, use of prior analgesia, and recruitment center.