An interventional study of Conventional venipuncture technique and MOLI technique in Acute Pain, Anxiety and Pain, Procedural, sponsored by José Luis Cobo Sánchez. Completed at 1 site in Spain. Open to participants aged 4 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by José Luis Cobo Sánchez · Not applicable, Interventional, and Supportive care
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.
Study design. Single-centre, parallel three-arm randomised controlled trial with 1:1:1 allocation, without blinding of participants or study personnel, and analysed under the intention-to-treat principle. Designed and reported in accordance with the CONSORT 2025 guidelines for parallel-group randomised trials and the TIDieR checklist for intervention description.
Setting and sample size. Conducted between 1 November 2024 and 31 August 2025 in the paediatric emergency department, paediatric short-stay unit and paediatric inpatient ward of a tertiary university hospital in northern Spain. Sample size was calculated using the GRANMO calculator to detect a between-group difference in pain intensity of at least 1 point (Faces Pain Scale-Revised) with an expected standard deviation of 0.5 points, accepting a two-sided alpha of 0.05, 80% power, an anticipated dropout rate of 5%, and Bonferroni adjustment for multiple pairwise comparisons. A total of 201 children (67 per arm) were required.
Randomisation. A statistician independent of the clinical team generated the randomisation sequence using Epidat 4.2 with permuted blocks of variable size (6 and 9). Group identifiers were placed in sealed, opaque, sequentially numbered envelopes. Because of the nature of the interventions, blinding of participants, families and staff was not possible. Statistical analysis was performed by an investigator who had not participated in allocation or intervention delivery.
Interventions. All interventions were delivered by paediatric nurses trained in a preparatory session before the trial start. The MOLI technique combined standardised positioning on the caregiver's lap, playful reframing of clinical devices, a forced slow-expiration exercise using a paper pinwheel held by the caregiver, and visual concealment of the venipuncture material by an assistant nurse. The virtual reality arm used a Meta Quest 3 headset with the Fruit Ninja VR application (Classic mode); positioning and family involvement were identical to the MOLI arm, replacing the pinwheel with the headset. The conventional arm consisted of standardised positioning, gentle limb restraint by an assistant nurse and family emotional support, without any structured distraction technique.
Outcomes. Primary outcomes were pain intensity (Faces Pain Scale-Revised, 0-10) and procedural anxiety (Groningen Distress Scale, 1-5) assessed immediately after peripheral venous catheter insertion. Secondary outcomes were pre and post-procedure heart rate (bpm), first-attempt insertion success, procedure duration, successful blood sampling and adverse events attributable to each intervention.
Statistical analysis. Continuous variables were summarised as mean and standard deviation or median and interquartile range depending on distribution. Between-group comparisons used the Kruskal-Wallis test with epsilon squared as the effect-size measure. Post-hoc pairwise comparisons were performed with Mann-Whitney U tests using Bonferroni adjustment for three comparisons, reporting r as the effect-size measure. Categorical variables were compared with the Chi-square test. A pre-specified age-subgroup analysis (4-6, 7-9, 10-12 years) was performed for the primary outcomes. All tests were two-sided at the 5% level.
908 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 201 is above the median of 87 across 759 interventional studies indexed under Acute Pain.
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Exclusion Criteria:
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.
Procedure: Conventional venipuncture technique
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.
Behavioral: MOLI technique
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.
Device: Meta Quest 3 with Fruit Ninja VR
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.
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.
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.
Time frame: 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.
Time frame: Immediately after peripheral venous catheter insertion (single assessment; approximately 1 minute after catheter fixation)
First-attempt PVC insertion success
Successful catheter insertion in the first attempt (yes/no).
Time frame: At the time of peripheral venous catheter insertion
Duration of the venipuncture procedure
Time (in minutes) from skin antisepsis to the fixation of the catheter dressing, measured by an external observer.
Time frame: From skin antisepsis to catheter dressing (typically less than 10 minutes)
Change in heart rate (pre to post insertion)
Difference between pre and post-procedure heart rate (bpm), measured with pulse oximetry.
Time frame: Immediately before and immediately after peripheral venous catheter insertion
Successful blood sampling
Successful collection of the required blood sample through the inserted catheter (yes/no).
Time frame: At the time of peripheral venous catheter insertion
Adverse events attributable to the intervention
Adverse events attributable to each intervention: motion sickness or visual discomfort in the VR arm; brief respiratory discomfort or vasovagal syncope in the MOLI arm; skin erythema or joint discomfort in the CT arm.
Time frame: During and immediately after the procedure
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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