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

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.

Study Overview

• Status: Recruiting
• Conditions: Difficult Intravenous Access; Procedural Fear in Children
• Intervention / Treatment: Other: Musical-Moving Toy Distraction

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayla Kaya Assoc. Prof. Dr., RN, PhD; Phone Number: +90 242 310 6103; Email: aylakaya@akdeniz.edu.tr
• Study Contact Backup: Name: Okan Kumaş Kumaş, RN; Phone Number: +90 542 297 2428; Email: o.kumas07@gmail.com

Study Locations

• Turkey (Türkiye)
  • Dumlupınar
    • Antalya, Dumlupınar, Turkey (Türkiye), 07058
      • Recruiting
      • Akdeniz University
      • Contact: Ayla Kaya, RN, PhD; Phone Number: +90 536 321 0029; Email: aylakaya@akdeniz.edu.tr
      • Sub-Investigator: Okan Kumaş, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children aged 4-6 years
• Children requiring peripheral intravenous catheterization in the pediatric emergency department
• Children with a Difficult Intravenous Access (DIVA) score ≥4
• Children whose parents or legal guardians provide informed consent for participation

Exclusion Criteria:

• Children with cognitive or developmental disorders that may interfere with fear assessment
• Children with visual or hearing impairments preventing interaction with the distraction toy
• Children who require urgent or life-saving interventions
• Children whose parents decline participation in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distraction With Musical-Moving Toy; Children in this group will receive distraction using a musical-moving toy during peripheral intravenous catheterization. The toy will be used to attract the child's attention during the procedure in order to reduce fear and distress.	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.
No Intervention: Standard Care; Children in the control group will receive standard care during peripheral intravenous catheterization without the use of the musical-moving toy distraction intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear Level During IV Catheterization	Fear levels of children will be assessed during the IV catheterization procedure using the Children's Fear Scale. Scores range from 0 to 4, with higher scores indicating greater fear.	During the IV catheterization procedure (approximately 5 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Success	Procedure success will be evaluated based on whether peripheral intravenous catheterization is successfully completed and the number of attempts required.	During the intravenous catheterization procedure
Procedure Duration	Procedure duration will be measured using a stopwatch and defined as the time from the start of catheterization preparation until successful catheter placement.	During the intravenous catheterization procedure

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Study Chair: Okan Kumaş Kumaş, RN, Akdeniz University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Peripheral Intravenous Catheterization; Difficult Intravenous Access; Pediatric Emergency; Distraction Technique; Children's Fear Scale
• Other Study ID Numbers: TBAEK-151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No