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NCT07770191
Distraction Methods for Reducing Pain and Fear During Blood Draw in Children
Conditions: Pain Management, Fear
Sex: All
Ages: 5 Years – 10 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 164
Sponsor: Gülsev Kutman
Location: Tekirdağ City Hospital Tekirdağ
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 Criteria
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
Source: ClinicalTrials.gov (NCT07770191). StuddyBuddy aggregates publicly available trial information.