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

ConditionProcedural Pain

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age3-15

SponsorMarie Lulková

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Known hypersensitivity to local anesthetics.

Diagnosed mental disorder.

Current treatment with analgesic or anxiolytic medications.

Venipuncture not successful on the first attempt.

Trial design

Design model

Parallel

Treatments tested in this trial

Virtual Reality Distraction
Behavioral
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
Drug
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.

Treatment groups

450 Participants

are divided into 3 treatment groups

Group A: Virtual RealityExperimental treatment 1 intervention

Group B: EMLA CreamActive comparator 1 intervention

Group C: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

Pain Intensity During 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.

Time frame

Immediately after venipuncture

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marie Lulková

Lead sponsor

Jan Evangelista Purkyne University

Sponsor institution

Source ClinicalTrials.gov

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