Clinical Trial

Effect of a Musical-Moving Toy Used During Difficult Peripheral Intravenous Catheterization on Children's Fear Level and Procedure Success

Completed
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Summary
Peripheral intravenous catheterization (PIVC) is a frequently performed invasive procedure in pediatric emergency departments and is often associated with fear and distress in children. Children with difficult intravenous access (DIVA) may require multiple attempts for successful catheterization, which can increase fear, anxiety, and procedure time. Non-pharmacological distraction techniques are commonly used to reduce procedural distress in children. This randomized controlled study aims to evaluate the effect of a musical-moving toy used as a distraction method during peripheral intravenous catheterization on children's fear levels, procedure success, and procedure duration. The study will be conducted in the pediatric emergency department of Antalya City Hospital in Türkiye. Children aged 4-6 years with difficult intravenous access will be randomly assigned to either an intervention group or a control group. In the intervention group, a musical-moving toy will be used during the catheterization procedure to distract the child, while the control group will receive standard care without the toy. Fear levels will be measured using the Children's Fear Scale. Procedure success will be evaluated by the number of attempts required to successfully insert the catheter, and procedure duration will be recorded using a stopwatch. The findings of this study may contribute to improving pediatric procedural care by providing an effective, low-cost, and easily applicable distraction method during intravenous catheterization.
Protocol Amendment History 3 changes
critical Trial completed 2026-07-14
notable Primary completion moved earlier: 2026-06 -> 2025-02-24 2026-07-14
minor Completion moved earlier: 2026-06 -> 2025-02-28 2026-07-14
Trial Details
NCT Number NCT07459517
Lead Sponsor Akdeniz University
Conditions Procedural Fear in Children, Difficult Intravenous Access
Enrollment 68 participants
Start Date 2024-11-28
Primary Completion 2025-02-24 (estimated)
Study Completion 2025-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-13