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

Esra Nur Kocaaslan Mutlu

Status: Not yet enrolling

Conditions: Pain Management

Treatments: Behavioral: Musical Toy (Xylophone); Other: Standard Care (in control arm)

Study type: Interventional

Funder types: Other

Identifiers

NCT06938776

TUTF-SBF-ENK-05

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 3 to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

64 participants in 2 patient groups

Arm 1: Musical Toy (Xylophone) Group

Experimental group

Description:

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.

Treatment:

Behavioral: Musical Toy (Xylophone)

Arm 2: Control Group

Other group

Description:

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

Treatment:

Other: Standard Care (in control arm)