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

Not Applicable

Not yet recruiting

• Conditions: Pain Management

• Registration Number: NCT06938776
• Lead Sponsor: Esra Nur Kocaaslan Mutlu

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-22
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25
• Study Start: 2025-05-15
• Primary Completion: 2025-10-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Parental Satisfaction	Within 5-10 minutes after the procedure	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.