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
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
Treatments tested in this trial
- Virtual Reality Distraction
- Lidocaine-Prilocaine Cream
Treatment groups
Sponsors and collaborators
Marie Lulková
Lead sponsor
Jan Evangelista Purkyne University
Sponsor institution