Comparison of the Efficacy of Virtual Reality and Topical Anesthetic During Venipuncture in Children: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Pain Intensity During Venipuncture
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Virtual Reality
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.
Intervention: Virtual Reality Distraction (Behavioral)
EMLA Cream
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.
Intervention: Lidocaine-Prilocaine Cream (Drug)
Standard Care
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Marie Lulková
Assistant Professor, Faculty of Health Studies
Jan Evangelista Purkyne University