[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636376":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":32,"locations":23,"responsibleParty":38,"collaborators":23,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":23,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":65,"whyStopped":23,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":23},{"fullName":5,"class":6},"Baskent University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Music Group","EXPERIMENTAL","Soft, slow-tempo instrumental music",[13],"Behavioral: Music Group",{"label":15,"type":10,"description":16,"interventionNames":17},"Musical Mobile Group","soft, slow-tempo instrumental music with visual movement",[18],"Behavioral: Musical Mobile Group",{"label":20,"type":21,"description":22,"interventionNames":23},"Control Group","NO_INTERVENTION","standart care",null,[25,29],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":23},"BEHAVIORAL","Soft, slow-tempo instrumental music will be played starting 10 minutes before chest tube removal, continued during the procedure, and maintained for 5 minutes after the procedure.",[9],{"type":26,"name":15,"description":30,"armGroupLabels":31,"otherNames":23},"A musical mobile providing audio-visual stimulation (soft, slow-tempo instrumental music with visual movement) will be used starting 10 minutes before the procedure, during, and for 5 minutes after.",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":23,"email":37},"Ayşe Ay, RN, Associate Professor","CONTACT","+905073560214","ayseay@baskent.edu.tr",{"type":39,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100636376","the-effect-of-music-and-musical-mobile-interventions-on-pain-and-physiological-parameters-100636376",false,"NCT07564882","The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters","The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters During Chest Tube Removal in Infants Undergoing Congenital Heart Surgery","Music Pain Inf","Inclusion Criteria:\n\n* Infants aged 2 to 12 months\n* Undergoing surgery due to congenital heart disease\n* Having a single chest tube\n* Not receiving mechanical ventilation support\n* Parent(s) voluntarily agree to participate in the study\n\nExclusion Criteria:\n\n* Receiving mechanical ventilation support\n* Administration of analgesics within 2 hours prior to chest tube removal\n* Presence of a neurodevelopmental disorder\n* Parent(s) do not consent to participate in the study","ALL","2 Months","12 Months",{"count":52,"type":53},54,"ESTIMATED","INTERVENTIONAL",[56],"NA","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.",[59,60],"Congenital Heart Disease (CHD)","Chest Tube Removal",[60,62,63,64],"Nursing","Congenital Heart Disease","Multisensory Distraction","NOT_YET_RECRUITING","2026-05-05",{"date":68,"type":69},"2026-05-08","ACTUAL",{"date":71,"type":53},"2026-04-30",{"date":73,"type":53},"2027-06-30",{"name":5,"class":6}]