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

Comparison of the Efficacy of Virtual Reality and Topical Anesthetic During Venipuncture in Children: a Randomized Controlled Trial

Registry ID
NCT07763132
Source registry
NCT
Status
RECRUITING
Phase
NA
Study type
INTERVENTIONAL
Sponsor
Marie Lulková
Enrollment
450
Start date
2024-09-01
Completion date
2027-06-01
Last update
2026-08-13

Conditions

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.

Interventions

Inclusion criteria

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

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 outcomes

[{"measure":"Pain Intensity During Venipuncture","timeFrame":"Immediately after venipuncture"}]

Locations

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