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MOLIVeR
Efficacy of the MOLI Technique and Virtual Reality Versus Conventional Venipuncture for Pain and Anxiety in Paediatric Patients: A Three-Arm Randomised Controlled Trial
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Instituto de Investigación Marqués de Valdecilla (IDIVAL)
OTHER · CEIm Cantabria (Research Ethics Committee approval code)
interventional
201
1 country
1
Study Start
November 1, 2024
Actual (reported)Primary Completion
August 31, 2025
Actual (reported)Study Completion
August 31, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2024
Actual (reported)August 31, 2025
Actual (reported)August 31, 2025
Actual (reported)September 21, 2026
Actual (reported)October 16, 2026
Actual (reported)Procedural pain intensity
Pain intensity measured with the Faces Pain Scale-Revised (FPS-R), a six-face pictorial self-report scale scored from 0 (no pain) to 10 (very much pain), validated for children aged 4-16 years.
Immediately after peripheral venous catheter insertion (single assessment; approximately 1 minute after catheter fixation)
Procedural anxiety
Procedural anxiety assessed with the observer-rated Groningen Distress Scale, scored from 1 (calm) to 5 (panic) by an external observer.
Immediately after peripheral venous catheter insertion (single assessment; approximately 1 minute after catheter fixation)
First-attempt PVC insertion success
Standard-care venipuncture without any structured distraction technique. The child was placed supine on the trolley with the head end elevated to 30 degrees. An assistant nurse gently restrained the limbs. The caregiver was positioned next to the assistant on the opposite side from the nurse, providing emotional support without interfering in the working field. Heart rate was monitored by pulse oximetry before insertion.
Structured active-distraction protocol combining positioning, visual concealment, playful reframing and pinwheel-guided breathing. In children up to 10 years the participant sat on the caregiver's lap; from 11 years the participant sat on the trolley. The nurse introduced the tourniquet ("strength bracelet") and the pulse oximeter ("red-light sticker") using a playful script. Immediately before skin antisepsis, the nurse handed a paper pinwheel to the caregiver, who held it 20-30 cm from the child's mouth. During insertion, the child was verbally prompted to "blow hard - spin the pinwheel" in a repeated fashion.
Standard-care venipuncture without structured distraction. Delivered by paediatric nurses of the participating units.
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.
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Jose Luis Cobo-Sanchez, RN, PhD, MBA
Hospital Universitario Marques de Valdecilla
201 participants (actual enrollment reported by the registry).
First Submitted
September 21, 2026
First Posted
October 16, 2026
At the time of peripheral venous catheter insertion
Duration of the venipuncture procedure
From skin antisepsis to catheter dressing (typically less than 10 minutes)
Change in heart rate (pre to post insertion)
Immediately before and immediately after peripheral venous catheter insertion
Successful blood sampling
At the time of peripheral venous catheter insertion
Adverse events attributable to the intervention
During and immediately after the procedure
Immersive virtual reality distraction. A Meta Quest 3 standalone headset was used with the Fruit Ninja VR application (Classic mode) as active distraction during catheter insertion. Positioning of the child, assistant nurse and caregiver was identical to the MOLI arm, replacing the pinwheel with the headset. The child operated the controller with the arm contralateral to the venipuncture site and was encouraged to "slice the fruit" throughout catheter insertion.
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.
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Study Start
November 1, 2024
Actual (reported)Primary Completion
August 31, 2025
Actual (reported)Study Completion
August 31, 2025
Actual (reported)Last Updated
October 16, 2026
Record last verified: 2025-11
Individual participant data are not planned to be shared publicly because of ethical constraints related to paediatric research participants. De-identified data may be made available from the corresponding author upon reasonable request and with the appropriate ethical approvals.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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