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Distraction Methods for Reducing Pain and Fear During Blood Draw in Children

Distraction Methods for Reducing Pain and Fear During Blood Draw in Children

Recruiting
5-10 years
All
Phase N/A

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Overview

Blood draw is a common invasive procedure that can cause pain and fear in children. This randomized controlled trial aims to compare the effects of pinwheel blowing, 3D hologram viewing, and sugar-free gum chewing on pain and fear during blood draw among children aged 5-10 years. Parental satisfaction with the care provided during the procedure will also be evaluated.

A total of 164 children will be assigned in a 1:1:1:1 ratio to the pinwheel blowing, 3D hologram viewing, gum chewing, or control group using block randomization stratified by age and sex. The interventions will begin one minute before the blood draw and continue until the procedure is completed. Children in the control group will receive the routine blood draw procedure without any additional nonpharmacological intervention.

Immediately after the blood draw, the child's pain and fear during the procedure will be independently evaluated by the child, the accompanying parent, and an independent observer nurse. Parental satisfaction will also be assessed after the procedure.

Description

This study is a four-arm, parallel-group randomized controlled trial involving children aged 5-10 years undergoing blood draw in a pediatric phlebotomy unit. The study aims to compare three nonpharmacological methods involving different mechanisms: active distraction through pinwheel blowing, passive visual distraction through 3D hologram viewing, and rhythmic oral and gustatory stimulation through flavored gum chewing.

Eligible children will be assigned to the study groups in a 1:1:1:1 ratio using block randomization stratified by sex (female or male) and age group (5-7 or 8-10 years). A block size of four will be used within each stratum.

In the pinwheel blowing group, children will begin blowing a colorful handheld pinwheel one minute before the blood draw and continue until the procedure is completed. In the 3D hologram viewing group, children will watch an age-appropriate holographic video featuring colorful flying butterflies, beginning one minute before the blood draw and continuing until the procedure is completed. In the gum chewing group, children will select a flavored sugar-free gum, begin chewing it one minute before the blood draw, and continue throughout the procedure. Children in the control group will receive the routine blood draw procedure without any additional pharmacological or nonpharmacological pain-relieving intervention. The accompanying parent will remain with the child throughout the procedure.

All blood draws will be performed by the same nurse, who has at least five years of pediatric phlebotomy experience, using a standardized procedure. Pain experienced during the blood draw will be assessed using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 to 10. Fear will be assessed using the Children's Fear Scale, which ranges from 0 to 4. Immediately after the procedure, pain and fear will be rated independently by the child, the accompanying parent, and an independent observer nurse. Parental satisfaction will be evaluated using a single-item numerical rating scale ranging from 1 to 10.

Because of the visible nature of the interventions, the children, parents, researcher delivering the interventions, phlebotomy nurse, and observer nurse cannot be blinded to group allocation.

Eligibility

Inclusion Criteria:

  • Children aged 5 to 10 years
  • Scheduled to undergo a blood draw
  • No analgesic medication use within 6 hours before the procedure
  • No visual, hearing, or speech impairment
  • No neurological disorder
  • No oral or jaw condition that may prevent gum chewing
  • No chronic illness requiring frequent invasive procedures
  • Written informed consent provided by the parent or legal guardian
  • Verbal assent provided by the children

Exclusion Criteria:

  • Previous history of syncope during blood draw procedures
  • Blood draw not completed on the first attempt
  • Development of syncope during the procedure
  • Inability or unwillingness to complete the assigned intervention
  • Withdrawal of consent or assent by the parent or child at any stage of the study

Study details
    Pain Management
    Fear

NCT07770191

Gülsev Kutman

22 August 2026

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