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

NCT07459517 | Recruiting

• 1 other identifier: TBAEK-151
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Procedural Fear in Children; Difficult Intravenous Access

Keywords

Peripheral Intravenous Catheterization; Difficult Intravenous Access; Pediatric Emergency; Distraction Technique; Children's Fear Scale; Randomized Controlled Trial

Outcome Measures

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.

  During the IV catheterization procedure (approximately 5 minutes)

Secondary Outcomes (2)

• Procedure Success

  During the intravenous catheterization procedure

• Procedure Duration

  During the intravenous catheterization procedure

Study Arms (2)

Distraction With Musical-Moving Toy

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Children in the control group will receive standard care during peripheral intravenous catheterization without the use of the musical-moving toy distraction intervention.

Interventions

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.

Distraction With Musical-Moving Toy

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Dumlupınar, 07058, Turkey (Türkiye)

RECRUITING

Study Officials

• Okan Kumaş Kumaş, RN

  Akdeniz University

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+90 242 310 6103; aylakaya@akdeniz.edu.tr

Okan Kumaş Kumaş, RN

CONTACT

+90 542 297 2428; o.kumas07@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to either an intervention group receiving distraction with a musical-moving toy during peripheral intravenous catheterization or a control group receiving standard care without the distraction intervention.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 9, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

TU (1)