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RECRUITING
NCT07763132
NA

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

Sponsor: Marie Lulková

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Years - 15 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2024-09-01

Completion Date

2027-06

Last Updated

2026-08-13

Healthy Volunteers

No

Conditions

Interventions

BEHAVIORAL

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.

DRUG

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.

Locations (1)

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem

Ústí nad Labem, Ústí nad Labem Region, Czechia