The Effect of a Musical Toy (Xylophone) on Pain, Fear, and Parental Satisfaction During Peripheral Intravenous Cannulation in Children Aged 3 to 6 Years

NCT ID: NCT06938776

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2025-12-15

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 is to evaluate whether the use of a musical toy during IV insertion reduces pain and fear in children. The secondary objective is to determine whether parental satisfaction with the healthcare experience is improved in the intervention group. Data will be collected before, during, and after the procedure.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Musical Toy (Xylophone)

Intervention Type: 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 2: Control Group

Children in this group will undergo the standard IV insertion procedure with no distraction technique. Standard hospital protocol will be followed.

Group Type: OTHER

Standard Care (in control arm)

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Esra Nur Kocaaslan Mutlu

OTHER

Sponsor Role: lead

Responsible Party

Esra Nur Kocaaslan Mutlu

Assistant Professor / Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Esra Nur Kocaaslan Mutlu, PhD, RN

Role: CONTACT

enurkocaaslan@trakya.edu.tr

+90 284 213 30 42/2128

Other Identifiers

TUTF-SBF-ENK-05

Identifier Type: -

Identifier Source: org_study_id