Interactive Musical Toy Reduces Pain and Fear During IV Cannulation in Preschool Children

Effect of a Musical Toy on Pain, Fear, and Parental Satisfaction During IV Cannulation in Hospitalized Children

This randomized controlled trial investigates the effects of using a musical toy (xylophone) as a distraction technique during peripheral intravenous cannulation on pain, fear, and parental satisfaction in hospitalized children aged 3 to 6 years. The study will be conducted in the Pediatric Health and Diseases Clinic of Trakya University in Edirne, Turkey.

A total of 64 children will be randomly assigned to either the intervention group or the control group. Children in the intervention group will be encouraged to play with a xylophone, accompanied by a nurse, before and during the cannulation procedure. The control group will receive standard care without any distraction. Pain levels will be measured using the Wong-Baker FACES Pain Rating Scale, fear will be assessed using the Children's Fear Scale, and parental satisfaction will be evaluated using the PedsQL Healthcare Satisfaction Scale.

The primary objective of this randomized controlled trial is to evaluate whether the use of a musical toy during peripheral intravenous cannulation reduces procedural fear in preschool children.

Secondary objectives are to determine whether the intervention reduces procedural pain and improves parental satisfaction with the healthcare experience

This study is expected to contribute to the evidence base supporting the use of non-pharmacological methods in pediatric pain management and to promote child-friendly approaches in clinical settings.

Study Overview

• Status: Completed
• Conditions: Pain Management
• Intervention / Treatment: Behavioral: Musical Toy (Xylophone); Other: Standard Care (in control arm)

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Edirne, Turkey (Türkiye), 22020
    • Trakya University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Children aged between 3 and 6 years
• Hospitalized and scheduled for peripheral intravenous cannulation
• No hearing or mental disabilities
• No chronic disease associated with pain
• No analgesic use in the past 6 hours
• One parent present during the procedure
• Both child and parent voluntarily agree to participate
• Intravenous cannulation to be performed in a single attempt
• Parent/guardian is literate

Exclusion Criteria:

• Children with hearing impairment or mental disabilities
• Use of analgesics within the last 6 hours
• Presence of chronic pain conditions
• Parental refusal to participate
• Failed intravenous cannulation attempt
• Illiterate parent/guardian
• Any parental mental disability
• Child or parent unwilling to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Arm 2: Control Group; Children in this group will undergo the standard IV insertion procedure with no distraction technique. Standard hospital protocol will be followed.	Other: Standard Care (in control arm); Children in this group will receive routine peripheral intravenous cannulation according to standard hospital protocols. No distraction or behavioral intervention will be applied.
Experimental: Arm 1: Musical Toy (Xylophone) Group; Children in this group will play with a colorful xylophone toy accompanied by a nurse before and during peripheral intravenous cannulation. The distraction is intended to reduce procedural pain and fear.	Behavioral: Musical Toy (Xylophone); Children in this group will play with a colorful xylophone toy for 5 minutes before and during peripheral intravenous cannulation. A nurse (researcher) will assist the child in playing with the toy to distract them from the procedure. The toy will be cleaned between uses. This non-pharmacological method aims to reduce pain and fear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2. Fear Level	Fear levels will be assessed using the Children's Fear Scale (CFS), which ranges from 0 (no fear) to 4 (extreme fear).	Before and within 5 minutes after the IV cannulation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental Satisfaction	Parental satisfaction regarding their child's IV experience will be evaluated using the PedsQL Healthcare Satisfaction Scale. Scores range from 0 to 100, with higher scores indicating greater satisfaction.	Within 5-10 minutes after the procedure
Pain Level	Children's pain levels will be measured using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 (no pain) to 5 (worst pain).	During and within 5 minutes after the IV cannulation procedure

Collaborators and Investigators

• Sponsor: Trakya University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2025
• Primary Completion (Actual): October 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: TUTF-SBF-ENK-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No