Using a musical-moving toy to calm young children during hard-to-place IVs
Effect of a Musical-Moving Toy Used During Difficult Peripheral Intravenous Catheterization on Children's Fear Level and Procedure Success: A Randomized Controlled Trial
This trial will try a musical-moving toy to see if it lowers fear and helps with IV placement in 4–6-year-old children who have difficult-to-find veins.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 4 Years to 6 Years |
| Sex | All |
| Sponsor | Akdeniz University Academic / other |
| Locations | 1 site (Antalya, Dumlupınar) |
| Trial ID | NCT07459517 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll children aged 4–6 with a Difficult Intravenous Access (DIVA) score ≥4 presenting to a pediatric emergency department. Participants will be randomly assigned to receive a musical-moving toy distraction during peripheral intravenous catheterization or to a control condition without the toy. Primary outcomes include the child's fear level during the procedure, success of catheter placement, and procedure duration. The intervention is non-pharmacological, easy to implement, and is compared against usual care in a single-center setting.
Who should consider this trial
Good fit: Children aged 4–6 who require peripheral IV catheterization, have a DIVA score of 4 or higher, and whose parent or guardian provides informed consent are ideal candidates.
Not a fit: Children with cognitive or developmental disorders, visual or hearing impairments that prevent interaction with the toy, those needing urgent life-saving interventions, or children with easily accessible veins are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the toy could reduce children's fear, decrease the number of IV attempts, and shorten procedure time during difficult IV insertions.
How similar studies have performed: Other non-pharmacological distraction methods (e.g., cartoons, virtual reality, distraction cards) have shown reductions in procedural distress, but musical-moving toys specifically have limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Antalya, Dumlupınar
- Akdeniz University — Antalya, Dumlupınar, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Ayla Kaya Assoc. Prof. Dr., RN, PhD
- Email: aylakaya@akdeniz.edu.tr
- Phone: +90 242 310 6103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.