NCT07564882 The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters
| NCT ID | NCT07564882 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Baskent University |
| Condition | Congenital Heart Disease (CHD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2026-06-30 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2026-06-30 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chest tube removal in infants undergoing surgery for congenital heart disease is an invasive procedure associated with significant pain and physiological stress responses. This randomized controlled trial evaluates the effects of music and musical mobile interventions on pain and physiological parameters during chest tube removal. A total of 54 infants aged 2-12 months are randomly assigned to music, musical mobile, or control groups. Pain is assessed using the FLACC scale, and physiological parameters (heart rate and oxygen saturation \[SpO₂\]) are monitored. Measurements are obtained at predefined time points: periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal). The findings aim to support evidence-based non-pharmacological pain management in pediatric intensive care settings.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07564882 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, up to 12 Months, studying Congenital Heart Disease (CHD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07564882 currently recruiting?
Yes, NCT07564882 is actively recruiting participants. Contact the research team at ayseay@baskent.edu.tr for enrollment information.
Where is the NCT07564882 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07564882 clinical trial?
NCT07564882 is sponsored by Baskent University. The trial plans to enroll 54 participants.