The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters (Music Pain Inf)
The Effect of Music and Musical Mobile Interventions on Pain and Physiological Parameters During Chest Tube Removal in Infants Undergoing Congenital Heart Surgery
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ayşe Ay, RN, Associate Professor
- Número de teléfono: +905073560214
- Correo electrónico: ayseay@baskent.edu.tr
Ubicaciones de estudio
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Ankara, Turquía (Türkiye)
- Reclutamiento
- Baskent University Ankara Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Grupo de control
atención estándar
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Experimental: Music Group
Soft, slow-tempo instrumental music
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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.
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Experimental: Musical Mobile Group
soft, slow-tempo instrumental music with visual movement
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain level assessed by FLACC Scale
Periodo de tiempo: [Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
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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.
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[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart rate
Periodo de tiempo: [Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
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Heart rate will be monitored and recorded at specified time points using a bedside monitor.
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[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
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Oxygen saturation (SpO₂)
Periodo de tiempo: [Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
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Oxygen saturation will be measured using a bedside monitor and recorded at specified time points.
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[Time Frame: Periprocedural (10 minutes before chest tube removal, immediately after removal, and 5 minutes post-removal)]
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Crying Duration
Periodo de tiempo: Time Frame: Periprocedural (during chest tube removal procedure)]
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Crying duration will be recorded in seconds throughout the chest tube removal procedure.
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Time Frame: Periprocedural (during chest tube removal procedure)]
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KA26/146
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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