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

NCT07763132 | Recruiting

• 1 other identifier: 321/1
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after venipuncture

Study Arms (3)

Virtual Reality

EXPERIMENTAL

Children assigned to this arm receive virtual reality distraction during venipuncture using a Meta Quest 3 headset. The same 360° wildlife video is presented to all participants. 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.

Behavioral: Virtual Reality Distraction

EMLA Cream

ACTIVE COMPARATOR

Children assigned to this arm receive topical EMLA cream containing lidocaine and prilocaine at the planned venipuncture site. The application site is covered with an occlusive dressing, and the cream is left in place for at least 60 minutes before venipuncture.

Drug: Lidocaine-Prilocaine Cream

Standard Care

NO INTERVENTION

Children assigned to this arm receive standard nursing care during venipuncture according to routine clinical practice. No additional pharmacological or non-pharmacological intervention specifically aimed at reducing procedural pain is provided.

Interventions

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.

Virtual Reality

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.

EMLA Cream

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Known hypersensitivity to local anesthetics.
• Diagnosed mental disorder.
• Current treatment with analgesic or anxiolytic medications.
• Venipuncture not successful on the first attempt.

Sponsors & Collaborators

• Marie Lulková: lead

Study Sites (1)

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

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

RECRUITING

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marie Lulková, Mgr.

CONTACT

+420733756630; marie.lulkova@kzcr.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Faculty of Health Studies

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 13, 2026
• Study Start: September 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

CZ (1)