Clinical trial NCT06938776: The Effect of a Musical Toy (Xylophone) on Pain, Fear, and Parental Satisfaction During Peripheral Intravenous Cannulation in Children Aged 3 to 6 Years
Official title: Effect of a Musical Toy on Pain, Fear, and Parental Satisfaction During IV Cannulation in Hospitalized Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain Management
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 64
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: 1. Pain Level
timeFrame: Within 5 minutes after the IV cannulation procedure
measure: 2. Fear Level
timeFrame: Before and within 5 minutes after the IV cannulation procedure
Secondary outcomes:
measure: Parental Satisfaction
timeFrame: Within 5-10 minutes after the procedure
Other outcomes:
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