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Recruiting Not applicable

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

NCT07770191 · tracked via the Priya Life Science Turkey tracker
Sponsor
Gülsev Kutman
Phase
Not applicable
Started
2026-06-15
Last updated
2026-08-18

Condition(s) studied

Pain ManagementFear

Investigational drug(s) / intervention(s)

3D Hologram ViewingPinwheel BlowingGum Chewing

3D Hologram Viewing: Children will watch an age-appropriate 3D holographic video featuring colorful flying butterflies. The holographic display will be positioned approximately 50 cm from the child. The intervention will begin one minute before the blood draw and continue until the procedure is completed.

Pinwheel Blowing: Children blow a colorful handheld pinwheel with a diameter of 16 cm. The intervention begins one minute before the blood draw and continues until the procedure is completed. Children hold the pinwheel with the hand not used for blood collection; the researcher holds it when necessary.

Gum Chewing: Children will select a 14.5-g piece of sugar-free flavored gum and begin chewing it one minute before the blood draw. The available flavors will include watermelon, strawberry, orange, and mixed fruit. Children will continue chewing the gum until the procedure is completed.

Study summary

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.

Eligibility

Sex
ALL
Min age
5 Years
Max age
10 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Child-Reported Pain Intensity During Blood Draw Assessed Using the Wong-Baker FACES Pain Rating Scale — Immediately after the blood draw, within approximately 5 minutes
    Pain experienced during the blood draw will be assessed by the child using the Wong-Baker FACES Pain Rating Scale. The scale consists of six faces scored as 0, 2, 4, 6, 8, and 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity.
  • Child-Reported Fear During Blood Draw Assessed Using the Children's Fear Scale — Immediately after the blood draw, within approximately 5 minutes
    Fear experienced during the blood draw will be assessed by the child using the Children's Fear Scale. The scale consists of five facial expressions scored from 0 to 4, where 0 indicates no fear and 4 indicates extreme fear. Higher scores indicate greater fear.

Trial sites (1)

FacilityCityRegionStatus
Tekirdağ City Hospital Tekirdağ Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07770191 on ClinicalTrials.gov ↗ ← All trials in Turkey