Virtual Reality for Pain Relief in Children During Vaccination: Randomized Pilot Study

OBJECTIVE: To assess the feasibility of a randomized clinical trial on the effectiveness of immersive virtual reality (IVR) headset in reducing children's pain perception during intramuscular vaccination compared to the traditional method. METHOD: This was a pilot study of a randomized, controlled, parallel, and open-label clinical trial. The study was divided into three phases: study proposal presentation, training of nursing technicians, and the pilot study. The primary outcome was the study's feasibility and sample size calculation, while the secondary outcomes included self-reported pain, behavior during vaccination, and the acceptability of IVR. The study is registered in the Brazilian Clinical Trials Registry under the number RBR-483ndsd. RESULTS: A total of 48 children were randomized, with 23 allocated to the intervention group (IG) and 25 to the control group (CG). High eligibility, recruitment, and adherence rates were observed, supporting the feasibility of conducting a full-scale randomized clinical trial. Additionally, 74% of children in the IG reported no pain, compared to 24% in the CG. All assessed behaviors were less pronounced in the IG. CONCLUSION: This pilot study demonstrated the feasibility of conducting a full-scale clinical trial and highlighted the potential for IVR headset to relieve pain during vaccination.