Immersive virtual reality trials with Latin American sites: a cross-sectional registry study of clinical areas, populations and outcome registration

Introduction: Immersive virtual reality (VR) trials are multiplying, but the clinical areas they address in Latin America and the completeness of their registry entries are unknown. This study described their clinical areas and populations and appraised the registration of primary outcomes, sample size justification, timing and results. Methods: Cross-sectional registry study of interventional ClinicalTrials.gov records with a VR intervention, at least one Latin American site and a start year from 2011 to 2023. Immersive trials documented a head-mounted display or explicit immersive wording. Counts, medians, Wilson 95% confidence intervals and crude Fisher exact tests were used; no adjusted model was fitted. Results: Of 62 records, 61 had a Latin American site and 14 were immersive VR trials, all single-site, from 5 countries. Procedural pain and anxiety (4 trials) and neurological rehabilitation (3) predominated, and median registered enrollment was 50. All trials registered primary outcomes with measure, description and time frame, 6 of 14 were registered prospectively, 1 stated a sample size justification and 1 of 8 closed trials posted results. No indicator differed from the 47 other VR-labelled trials. Conclusions: Registered immersive VR trials with Latin American sites were few, small and concentrated in pain, anxiety and neurological rehabilitation. Primary outcome fields were complete, but prospective registration, sample size justification and results posting were limited.