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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorAkdeniz University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Musical-Moving Toy Distraction

    Other intervention

    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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Distraction With Musical-Moving ToyExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

Procedure Success

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

Time frame
During the intravenous catheterization procedure
2

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.

Time frame
During the intravenous catheterization procedure

Other outcomes

Sponsors and contacts

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