Actively Recruiting

Phase Not Applicable
Age: 4Years - 6Years
All Genders
Healthy Volunteers
NCT07459517

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

Led by Akdeniz University · Updated on 2026-03-10

70

Participants Needed

1

Research Sites

11 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 4Years - 6Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 4 to 6 years
  • Children requiring peripheral intravenous catheterization in the pediatric emergency department
  • Children with a Difficult Intravenous Access (DIVA) score of 4 or higher
  • Children whose parents or legal guardians provide informed consent for participation
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Akdeniz University

Antalya, Dumlupınar, Turkey (Türkiye), 07058

Actively Recruiting

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Research Team

A

Ayla Kaya Assoc. Prof. Dr., RN, PhD

CONTACT

O

Okan Kumaş Kumaş, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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