MOLI Technique and Virtual Reality Versus Conventional Venipuncture for Pain and Anxiety in Children

Venipuncture is one of the most frequent and distressing invasive procedures in paediatric care. Both immersive virtual reality (VR) and structured breathing-based active distraction have been proposed as effective non-pharmacological strategies to reduce procedural pain and anxiety. However, no randomised controlled trial has directly compared a structured breathing-based intervention with immersive VR and with the conventional technique. The MOLIVeR trial is a single-centre, parallel three-arm randomised controlled trial (1:1:1 allocation) that compared the MOLI technique (a Spanish acronym for movilizacion, observacion, ludica e inmersion, matching the English Mobilisation, Observation, Ludic engagement and Immersion; a pinwheel-guided active-distraction breathing protocol), immersive VR (Meta Quest 3, Fruit Ninja VR) and the conventional technique in children aged 4-12 years requiring peripheral venous catheter insertion in a tertiary university hospital in Spain. The primary outcomes were pain intensity (Faces Pain Scale-Revised) and procedural anxiety (Groningen Distress Scale), assessed immediately after catheter insertion. Secondary outcomes were pre and post-procedure heart rate, first-attempt insertion success, procedure duration and adverse events. Analyses followed the intention-to-treat principle.