An interventional study of Music Group and Musical Mobile Group in Congenital Heart Disease (CHD) and Chest Tube Removal, sponsored by Baskent University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 2 Months to 12 Months. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Baskent University · Not applicable, Interventional, and Treatment
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.
Chest tube removal is a common but painful procedure in infants undergoing surgery for congenital heart disease and may trigger significant physiological stress responses. Although pharmacological interventions are commonly used, concerns about potential side effects highlight the importance of non-pharmacological approaches.
This study is a randomized controlled trial designed to evaluate the effects of music and musical mobile interventions on procedural pain and physiological parameters. The study is conducted in the Pediatric Cardiovascular Surgery Intensive Care Unit of Başkent University Ankara Hospital. The sample consists of 54 infants aged 2-12 months who meet the eligibility criteria.
Participants are randomly allocated to three groups (music, musical mobile, and control) using block randomization. In the music group, auditory stimulation consisting of ocean and nature sounds is initiated 10 minutes before chest tube removal, continued during the procedure, and maintained for 5 minutes after the procedure. In the musical mobile group, a multisensory intervention combining auditory and visual stimuli is applied during the same time interval. The control group receives standard care routinely provided in the unit.
Pain is assessed using the FLACC Scale. Physiological parameters, including heart rate and oxygen saturation (SpO₂), are monitored using bedside monitors. Outcomes are recorded at predefined time points: periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal). Crying duration is recorded continuously during the chest tube removal procedure.
Statistical analyses are performed using SPSS software. Depending on data distribution, appropriate parametric or non-parametric tests are applied. This study aims to provide evidence on the effectiveness of multisensory distraction interventions in reducing procedural pain and improving physiological stability in infants undergoing chest tube removal.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's planned enrollment of 54 is close to the median of 60 across 507 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Baskent University is the lead sponsor of 209 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Soft, slow-tempo instrumental music
Behavioral: Music Group
soft, slow-tempo instrumental music with visual movement
Behavioral: Musical Mobile Group
standart care
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.
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.
Pain level assessed by FLACC Scale
Pain will be evaluated using the FLACC (Face, Legs, Activity, Cry, Consolability) Scale. Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Time frame: [Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
Heart rate
Heart rate will be monitored and recorded at specified time points using a bedside monitor.
Time frame: [Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
Oxygen saturation (SpO₂)
Oxygen saturation will be measured using a bedside monitor and recorded at specified time points.
Time frame: [Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
Crying Duration
Crying duration will be recorded in seconds throughout the chest tube removal procedure.
Time frame: Time Frame: Periprocedural (during chest tube removal procedure)]
Plan to share: Undecided
Started Jun 2026 (actual). Primary completion is estimated for Apr 2027, 10 months after the start.
Of 205 non-industry interventional studies with no phase under Heart Defects, Congenital, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 10 months is below that.
Counting every sponsor, half of 223 studies reached it within 34 months; a quarter within 17 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.