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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 [SpOâ‚‚]) 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 BaÅŸkent 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 (SpOâ‚‚), 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Group | Experimental | Soft, slow-tempo instrumental music |
|
| Musical Mobile Group | Experimental | soft, slow-tempo instrumental music with visual movement |
|
| Control Group | No Intervention | standart care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Group | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)] |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | Heart rate will be monitored and recorded at specified time points using a bedside monitor. | [Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)] |
| Oxygen saturation (SpOâ‚‚) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AyÅŸe Ay, RN, Associate Professor | Contact | +905073560214 | ayseay@baskent.edu.tr |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 1. Arabiat, D., Mörelius, E., Hoti, K., & Hughes, J. (2023). Pain assessment tools for use in infants: a meta-review. BMC pediatrics, 23(1), 307. 2. Bates, K. E., Madsen, N. L., Khadr, L., Gao, Z., Crawford, K., Gaies, M., Graupe, M., Hanke, S. P., Hlavacek, A. M., Morell, E., Pasquali, S. K., Russell, J. L., Schachtner, S. K., Tanel, R. E., Ware, A. L., & Kipps, A. K. (2021). Center Variation in Chest Tube Duration and Length of Stay After Congenital Heart Surgery. The Annals of thoracic surgery, 110(1), 221-227. https://doi.org/10.1016/j.athoracsur.2019.09.078 3. Bertrandt, R. A., Saudek, D. M., Scott, J. P., Madrzak, M., Miranda, M. B., Ghanayem, N. S., & Woods, R. K. (2019). Chest tube removal algorithm is associated with decreased chest tube duration in pediatric cardiac surgical patients. The Journal of thoracic and cardiovascular surgery, 158(4), 1209-1217. 4. Blinder, J. J., Thiagarajan, R., Williams, K., Nathan, M., Mayer, J., & Kulik, T. J. (2017). Duration of mechanical ventilation and perioperative care quality after neonatal cardiac operations. The Annals of Thoracic Surgery, 103(6), 1956-1962. https://doi.org/10.1016/j.athoracsur.2016.11.077 5. Clarke, S. L., Milburn, N. C., Menzies, J. C., & Drury, N. E. (2024). The provision and impact of rehabilitation provided by physiotherapists in children and young people with congenital heart disease following cardiac surgery: a scoping review. Physiotherapy, 122, 47-56. https://doi.org/10.1016/j.physio.2023.09.001 6. Duran Küçük, G. (2025). Çocuklarda göğüs tüpü çıkarma işlemi öncesi uygulanan lidokain-prilokain krem ve soğuk uygulamanın ağrı, anksiyete ve yaşamsal bulgulara etkisi: Randomize kontrollü çalışma (Yayımlanmamış yüksek lisans tezi). İstanbul Medeniyet Üniversitesi, Lisansüstü Eğitim Enstitüsü. 7. Ertürk, E. B., & Karadağ, M. (2020). Göğüs tüpü çıkarılma işleminin neden olduğu ağrı ve anksiyetenin kontrolünde uygulanan farmakolojik olmayan yöntemler. Türk Hemşireler Derneği Dergisi, 1(1), 53-68. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Musical Mobile Group | Behavioral | 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. |
|
Oxygen saturation will be measured using a bedside monitor and recorded at specified time points. |
| [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: Periprocedural (during chest tube removal procedure)] |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |