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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07763132

Enrollment

450

Registered

2026-08-13

Start date

2024-09-01

Completion date

2027-06-01

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural Pain

Keywords

Venipuncture, Virtual Reality, EMLA Cream, Topical Anesthesia, Pediatric Pain, Children, Distraction

Brief 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

BEHAVIORALVirtual 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.

DRUGLidocaine-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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 15 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Czechia

Contacts

CONTACTMarie Lulková, Mgr.

marie.lulkova@kzcr.eu+420733756630

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026