Ireland
--:--IST
Recruiting Not applicable

Comparison of Virtual Reality, EMLA Cream, and Standard Care for Pain During Blood Draws in Children

NCT07763132 · tracked via the Priya Life Science Czechia tracker
Sponsor
Marie Lulková
Phase
Not applicable
Started
2024-09-01
Last updated
2026-08-13

Condition(s) studied

Procedural Pain

Investigational drug(s) / intervention(s)

Virtual Reality DistractionLidocaine-Prilocaine Cream →

Virtual Reality Distraction: Virtual reality distraction is provided during venipuncture using a Meta Quest 3 headset. All participants assigned to this intervention view the same 360° wildlife video. Children can change the direction of view by moving their head but cannot control the content or sequence of the video. The headset is used throughout the venipuncture procedure.

Lidocaine-Prilocaine Cream: Topical EMLA cream containing lidocaine and prilocaine is applied to the planned venipuncture site, covered with an occlusive dressing, and left in place for at least 60 minutes before venipuncture.

Study summary

This randomized controlled trial evaluates methods to reduce pain during venipuncture in children aged 3 to 15 years. The study compares three approaches: virtual reality distraction using a VR headset, topical anesthesia with EMLA cream, and standard care without an additional pain-reducing intervention. The main question is whether virtual reality reduces pain during venipuncture more effectively than EMLA cream or standard care. Pain is assessed immediately after venipuncture using the Wong-Baker Faces Pain Rating Scale (0-10). The planned study sample includes 450 children.

Eligibility

Sex
ALL
Min age
3 Years
Max age
15 Years
Healthy volunteers
No
Inclusion Criteria: * Children aged 3 to 15 years. * Clinical indication for venipuncture. * Written informed consent provided by a parent or legal guardian and verbal or written assent from the child, as appropriate for age and cognitive ability. Exclusion Criteria: * Known hypersensitivity to local anesthetics. * Diagnosed mental disorder. * Current treatment with analgesic or anxiolytic medications. * Venipuncture not successful on the first attempt.

Primary outcome measure(s)

  • Pain Intensity During Venipuncture — Immediately after venipuncture
    Pain intensity is self-reported immediately after venipuncture using the Wong-Baker Faces Pain Rating Scale (0-10), where 0 indicates no pain and 10 indicates the worst pain. Lower scores indicate lower perceived pain intensity.

Trial sites (1)

FacilityCityRegionStatus
Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem Ústí nad Labem Ústí nad Labem Region Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07763132 on ClinicalTrials.gov ↗ ← All trials in Czechia