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MOLI Technique and Virtual Reality Versus Conventional Venipuncture for Pain and Anxiety in Children
Sponsor: José Luis Cobo Sánchez
Summary
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.
Official title: Efficacy of the MOLI Technique and Virtual Reality Versus Conventional Venipuncture for Pain and Anxiety in Paediatric Patients: A Three-Arm Randomised Controlled Trial
Key Details
Gender
All
Age Range
4 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
201
Start Date
2024-11-01
Completion Date
2025-08-31
Last Updated
2026-10-16
Healthy Volunteers
No
Interventions
Conventional venipuncture technique
Standard-care venipuncture without structured distraction. Delivered by paediatric nurses of the participating units.
MOLI technique
Structured active-distraction protocol combining standardised positioning on the caregiver's lap, playful reframing of clinical devices (tourniquet as strength bracelet, pulse oximeter as red-light sticker), pinwheel-guided slow forced expiration held by the caregiver, and visual concealment of the venipuncture material by an assistant nurse. Delivered by paediatric nurses trained in a pre-trial standardisation session, with a supporting leaflet and demonstration videos.
Meta Quest 3 with Fruit Ninja VR
Immersive virtual reality distraction using a Meta Quest 3 standalone headset (Meta Platforms, Inc.) with the Fruit Ninja VR application (Halfbrick Studios) in Classic mode. Delivered together with the same caregiver positioning, playful reframing and visual concealment used in the MOLI arm.
Locations (1)
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain