Tekirdağ City Hospital
Tekirdağ, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07770191
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.
Interested in participating?
Request Info5 year–10 year
All sexes
Interventional
Not applicable
Tekirdağ, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after the blood draw, within approximately 5 minutes
Parental satisfaction with the care provided during the blood draw procedure will be assessed using a single-item numerical rating scale ranging from 1 to 10, where 1 indicates the lowest level of satisfaction and 10 indicates the highest level of satisfaction. Higher scores indicate greater parental satisfaction.
Contact information is provided by the study sponsor or research team.
Gülsev Kutman
Other Gov
Effects of Pinwheel Blowing, 3D Hologram Viewing, and Gum Chewing on Pain and Fear During Blood Draw in Children: A Randomized Controlled Trial
Acronym: PED-DISTRACT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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