Clinical Trial

Interactive Musical Toy Reduces Pain and Fear During IV Cannulation in Preschool Children

Completed
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Summary
This randomized controlled trial investigates the effects of using a musical toy (xylophone) as a distraction technique during peripheral intravenous cannulation on pain, fear, and parental satisfaction in hospitalized children aged 3 to 6 years. The study will be conducted in the Pediatric Health and Diseases Clinic of Trakya University in Edirne, Turkey. A total of 64 children will be randomly assigned to either the intervention group or the control group. Children in the intervention group will be encouraged to play with a xylophone, accompanied by a nurse, before and during the cannulation procedure. The control group will receive standard care without any distraction. Pain levels will be measured using the Wong-Baker FACES Pain Rating Scale, fear will be assessed using the Children's Fear Scale, and parental satisfaction will be evaluated using the PedsQL Healthcare Satisfaction Scale. The primary objective of this randomized controlled trial is to evaluate whether the use of a musical toy during peripheral intravenous cannulation reduces procedural fear in preschool children. Secondary objectives are to determine whether the intervention reduces procedural pain and improves parental satisfaction with the healthcare experience This study is expected to contribute to the evidence base supporting the use of non-pharmacological methods in pediatric pain management and to promote child-friendly approaches in clinical settings.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-14; most recent amendment 2026-03-19.
Status change: Not Yet Recruiting → Completed 2026-03-19
Trial Details
NCT Number NCT06938776
Lead Sponsor Trakya University
Conditions Pain Management
Enrollment 64 participants
Start Date 2025-05-15
Primary Completion 2025-10-15 (estimated)
Study Completion 2025-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-23