Music and Multisensory Interventions for Pain During Chest Tube Removal in Infants with Congenital Heart Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial assigns 54 infants with congenital heart disease to one of three groups: music, a multisensory musical mobile, or standard care during chest tube removal. Pain is measured with the FLACC scale and physiological responses like heart rate and oxygen saturation are monitored at multiple time points around the procedure. The music group uses ocean and nature sounds starting 10 minutes before removal and continuing after, while the musical mobile group adds visual stimuli. Outcomes focus on procedural pain and physiological stress to inform non-pharmacological pain management in pediatric cardiac care settings. The study is conducted at Başkent University Ankara Hospital and uses block randomization to assign participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Infants aged 2 to 12 months
* Undergoing surgery due to congenital heart disease
* Having a single chest tube
* Not receiving mechanical ventilation support
* Parent(s) voluntarily agree to participate in the study

Exclusion Criteria:

* Receiving mechanical ventilation support
* Administration of analgesics within 2 hours prior to chest tube removal
* Presence of a neurodevelopmental disorder
* Parent(s) do not consent to participate in the study

Where it's running

• Başkent University Ankara Hospital
  Ankara, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Ayşe Ay, RN, Associate Professor
• Email: ayseay@baskent.edu.tr
• Phone: +905073560214

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.