NCT07459517

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Akdeniz University · Academic / Other
• Sex: All
• Age: 4 Years – 6 Years
• Healthy volunteers: Accepted

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.

Detailed description

Peripheral intravenous catheterization (PIVC) is one of the most commonly performed invasive procedures in pediatric emergency departments for the administration of fluids, medications, and blood products. However, PIVC procedures can cause significant fear, anxiety, and distress in children. These negative experiences may lead to behavioral reactions such as crying, resistance, and refusal of treatment, which may complicate the procedure and increase procedure duration. Children with difficult intravenous access (DIVA) represent a particularly challenging group, as multiple attempts may be required to successfully place a catheter. Previous research has shown that non-pharmacological distraction techniques can reduce pain, fear, and anxiety during invasive procedures in children. These techniques are inexpensive, easy to implement, and widely used in pediatric nursing practice. Various distraction methods such as cartoons, balloon inflation, virtual reality, and distraction cards have been investigated in previous studies. However, limited evidence exists regarding the effectiveness of musical-moving toys as a distraction method during difficult intravenous catheterization procedures in young children. This study is designed as a randomized controlled trial to evaluate the effect of a musical-moving toy used during PIVC procedures on children's fear level, procedure success, and procedure duration. The study will be conducted in the pediatric emergency department blood collection room of Antalya City Hospital. A total of 70 children aged 4-6 years with a Difficult Intravenous Access Score (DIVA score) of 4 or higher will be included in the study. Participants will be randomly assigned to either an intervention group (n=35) or a control group (n=35) using simple randomization. In the intervention group, a musical-moving toy will be used during the PIVC procedure to distract the child. The control group will receive standard care without the distraction intervention. Data will be collected using a Child Information Form, the Difficult Intravenous Access Score (DIVA), the Children's Fear Scale, and measurement of procedure duration using a stopwatch. Statistical analysis will be conducted using SPSS software with the support of a statistician. The results of this study may contribute to improving the management of procedural fear in pediatric patients and may support the use of simple distraction techniques to improve procedural success and efficiency in pediatric emergency care.

Conditions

• Procedural Fear in Children
• Difficult Intravenous Access

Interventions

Type	Name	Description
OTHER	Musical-Moving Toy Distraction	A musical-moving toy will be used as a distraction technique during peripheral intravenous catheterization. The toy will be presented to the child during the procedure to attract attention and reduce fear and distress associated with the catheterization process.

Timeline

• Start date: 2026-03-15
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2026-03-09
• Last updated: 2026-03-10

Locations

1 site across 1 country: Turkey (Türkiye)