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NCT Number: NCT07763132

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

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.

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Key information

Conditions

Procedural Pain Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Ústí nad Labem, Ústí nad Labem Region, 40011, Czechia

Location status: Recruiting

Location contact

Marie Lulková, Mgr.

CONTACT

[email protected]

+420733756630

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Pain Intensity During Venipuncture

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marie Lulková, Mgr.

CONTACT

[email protected]

+420733756630

Sponsors and collaborators

Lead sponsor

Marie Lulková

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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