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NCT Number: NCT07459517

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

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.

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, Dumlupınar, 07058, Turkey (Türkiye)

About this study

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 68 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=34) or a control group (n=34) 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Musical-Moving Toy Distraction

Other

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.

Primary outcomes

  1. Fear Level During IV Catheterization

    Time frame: During the IV catheterization procedure (approximately 5 minutes)

    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.

Secondary outcomes

  1. Procedure Success

    Time frame: During the intravenous catheterization procedure

    Procedure success will be evaluated based on whether peripheral intravenous catheterization is successfully completed and the number of attempts required.

  2. Procedure Duration

    Time frame: During the intravenous catheterization procedure

    Procedure duration will be measured using a stopwatch and defined as the time from the start of catheterization preparation until successful catheter placement.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 9, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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