CompletedNot Applicable

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

Turkey (Türkiye)64 participantsStarted 2025-05-15

Plain-language 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.

Who can participate

Age range

3 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

2. Fear Level

Timeframe: Before and within 5 minutes after the IV cannulation procedure

Trial details

NCT IDNCT06938776

SponsorTrakya University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-15

View on ClinicalTrials.gov More Pain Management trials