Effect of a Musical-Moving Toy Used During Difficult Peripheral Intravenous Catheterization on Children's Fear Level and Procedure Success: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Akdeniz University
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Fear Level During IV Catheterization
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Distraction With Musical-Moving Toy
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.
Intervention: Musical-Moving Toy Distraction (Other)
Standard Care
Children in the control group will receive standard care during peripheral intravenous catheterization without the use of the musical-moving toy distraction intervention.
Outcomes
Primary Outcomes
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
- Procedure Success(During the intravenous catheterization procedure)
- Procedure Duration(During the intravenous catheterization procedure)
Investigators
Ayla Kaya
Principal Investigator
Akdeniz University