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

NCT06938776 | Completed

• 1 other identifier: TUTF-SBF-ENK-05
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain Level

  During and within 5 minutes after the IV cannulation procedure

• Parental Satisfaction

  Within 5-10 minutes after the procedure

Study Arms (2)

Arm 1: Musical Toy (Xylophone) Group

EXPERIMENTAL

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)

Arm 2: Control Group

OTHER

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)

Interventions

Musical Toy (Xylophone) BEHAVIORAL

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.

Arm 1: Musical Toy (Xylophone) Group

Standard Care (in control arm) OTHER

Children in this group will receive routine peripheral intravenous cannulation according to standard hospital protocols. No distraction or behavioral intervention will be applied.

Arm 2: Control Group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University Hospital

Edirne, 22020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, children, parents, and the nurse delivering the intervention could not be blinded. Outcome assessments (fear and pain) were conducted using video recordings evaluated by an independent researcher who was blinded to group assignment. All recordings were coded and anonymized. The statistician performing the analysis was also blinded, and group labels were masked (Group A and Group B) during statistical analysis to minimize detection and analytical bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor / Principal Investigator

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: May 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: December 15, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)