The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial
4 de abril de 2021 actualizado por: noa ziv, Rabin Medical Center
Bronchiolitis is an infectious disease, with no effective treatment.
Music and Mozart's works specifically, has been shown to have a positive effect on physiological parameters, while environmental noise is considered to be harmful.
We aimed to evaluate the short-time effect of listening to music and detachment from environmental noise on the severity of bronchiolitis in hospitalized children.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
MP3 player devices were uploaded with 3 different pieces: 1) sonata for 2 pianos in D major, K.488 by Mozart (2) instrumental music ("To the Point", by Dean Evenson & Tom Barabas) and (3) silence. All music or silence pieces were identical in length (24 minutes in accordance to the duration of the sonata).
Music fragments were played using headphones suitable and approved for use in children - GSI (Grason-Standler) Insert Earphone TIP-50 (50 ohm) (Grason Standler Inc. Madison, WI, USA). Sound frequency and volume were adjusted to the age appropriate values33 Children were randomly divided into 3 groups according to the type of intervention. Randomization, numbering of the MP3 players and coding of the content were done by a research coordinator not involved in evaluation of the patients nor in analysis of the results.
Tipo de estudio
Intervencionista
Inscripción (Actual)
52
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Petach Tikva, Israel, 4920235
- Schneider Children's Medical Center of Israel
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
No mayor que 2 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients aged 0-24 months, with the clinical diagnosis of bronchiolitis.
Exclusion Criteria:
- Children who failed neonatal hearing screening or in whom the results of the screening were not available were excluded from the study.
- Children who were not able to maintain listening for at least 10 minutes were excluded from data analysis
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Sonata for 2 pianos in D major, K.488 by Mozart
An Mp3 player, upload with music by Mozart.
Music was played using headphones suitable and approved for use in children.
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Music composed by Mozart, a musical piece 24 minutes long.
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Comparador activo: Instrumental music ("To the Point", by Dean Evenson & Tom Barabas)
An Mp3 player, upload with instrumental music.
Music was played using headphones suitable and approved for use in children.
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Instrumental music , a musical piece 24 minutes long
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Comparador activo: Silence
An Mp3 player, upload with silence.
Silence was played using headphones suitable and approved for use in children.
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Silence, a piece 24 minutes long.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in disease severity
Periodo de tiempo: Evaluation was done before music playing and immediately after the end of the music session (At 0 minutes time, and at a maximum time of 24 minutes from the beginning of intervention - which is the length of the musical piece).
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Evaluated by Modified Tal Score (Respiratory rate, O2 saturation, use of accessory respiratory muscles, breath sounds: wheezing)
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Evaluation was done before music playing and immediately after the end of the music session (At 0 minutes time, and at a maximum time of 24 minutes from the beginning of intervention - which is the length of the musical piece).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Noa Ziv, MD, Schneider Children's Medical Center, Israel
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Lubetzky R, Mimouni FB, Dollberg S, Reifen R, Ashbel G, Mandel D. Effect of music by Mozart on energy expenditure in growing preterm infants. Pediatrics. 2010 Jan;125(1):e24-8. doi: 10.1542/peds.2009-0990. Epub 2009 Dec 7.
- Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742. Erratum In: Pediatrics. 2015 Oct;136(4):782.
- Golino AJ, Leone R, Gollenberg A, Christopher C, Stanger D, Davis TM, Meadows A, Zhang Z, Friesen MA. Impact of an Active Music Therapy Intervention on Intensive Care Patients. Am J Crit Care. 2019 Jan;28(1):48-55. doi: 10.4037/ajcc2019792.
- Lee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19. Erratum In: J Music Ther. 2021 Aug 24;58(3):372.
- Finn S, Fancourt D. The biological impact of listening to music in clinical and nonclinical settings: A systematic review. Prog Brain Res. 2018;237:173-200. doi: 10.1016/bs.pbr.2018.03.007. Epub 2018 May 1.
- Friedman JN, Rieder MJ, Walton JM; Canadian Paediatric Society, Acute Care Committee, Drug Therapy and Hazardous Substances Committee. Bronchiolitis: Recommendations for diagnosis, monitoring and management of children one to 24 months of age. Paediatr Child Health. 2014 Nov;19(9):485-98. doi: 10.1093/pch/19.9.485.
- Ricci V, Delgado Nunes V, Murphy MS, Cunningham S; Guideline Development Group and Technical Team. Bronchiolitis in children: summary of NICE guidance. BMJ. 2015 Jun 2;350:h2305. doi: 10.1136/bmj.h2305. No abstract available.
- Kassis I, Srugo I, Srur S, Horowitz Y, Almagor T, Wolf D, Kra-Oz Z, Kennes Y, Rishpon S, Miron D. [The burden and outcomes of acute bronchiolitis among young children hospitalized in Israel]. Harefuah. 2009 Nov;148(11):748-51, 795, 794. Hebrew.
- Kou M, Hwang V, Ramkellawan N. Bronchiolitis: From Practice Guideline to Clinical Practice. Emerg Med Clin North Am. 2018 May;36(2):275-286. doi: 10.1016/j.emc.2017.12.006. Epub 2018 Feb 10.
- Hasegawa K, Tsugawa Y, Brown DF, Mansbach JM, Camargo CA Jr. Trends in bronchiolitis hospitalizations in the United States, 2000-2009. Pediatrics. 2013 Jul;132(1):28-36. doi: 10.1542/peds.2012-3877. Epub 2013 Jun 3.
- Vaajoki A, Kankkunen P, Pietila AM, Vehvilainen-Julkunen K. Music as a nursing intervention: effects of music listening on blood pressure, heart rate, and respiratory rate in abdominal surgery patients. Nurs Health Sci. 2011 Dec;13(4):412-8. doi: 10.1111/j.1442-2018.2011.00633.x. Epub 2011 Sep 8.
- Pauwels EK, Volterrani D, Mariani G, Kostkiewics M. Mozart, music and medicine. Med Princ Pract. 2014;23(5):403-12. doi: 10.1159/000364873. Epub 2014 Jul 19.
- Warren JD. Variations on the musical brain. J R Soc Med. 1999 Nov;92(11):571-5. doi: 10.1177/014107689909201108. No abstract available.
- Loomba RS, Arora R, Shah PH, Chandrasekar S, Molnar J. Effects of music on systolic blood pressure, diastolic blood pressure, and heart rate: a meta-analysis. Indian Heart J. 2012 May-Jun;64(3):309-13. doi: 10.1016/S0019-4832(12)60094-7.
- Uchiyama M, Jin X, Zhang Q, Hirai T, Amano A, Bashuda H, Niimi M. Auditory stimulation of opera music induced prolongation of murine cardiac allograft survival and maintained generation of regulatory CD4+CD25+ cells. J Cardiothorac Surg. 2012 Mar 23;7:26. doi: 10.1186/1749-8090-7-26.
- Tolunay T, Bicici V, Tolunay H, Akkurt MO, Arslan AK, Aydogdu A, Bingol I. Rhythm and orthopedics: The effect of music therapy in cast room procedures, a prospective clinical trial. Injury. 2018 Mar;49(3):593-598. doi: 10.1016/j.injury.2018.02.008. Epub 2018 Feb 7.
- McConnell T, Porter S. Music therapy for palliative care: A realist review. Palliat Support Care. 2017 Aug;15(4):454-464. doi: 10.1017/S1478951516000663. Epub 2016 Oct 24.
- Stegemann T, Geretsegger M, Phan Quoc E, Riedl H, Smetana M. Music Therapy and Other Music-Based Interventions in Pediatric Health Care: An Overview. Medicines (Basel). 2019 Feb 14;6(1):25. doi: 10.3390/medicines6010025.
- Rauscher FH, Shaw GL, Ky KN. Music and spatial task performance. Nature. 1993 Oct 14;365(6447):611. doi: 10.1038/365611a0. No abstract available.
- Coppola G, Toro A, Operto FF, Ferrarioli G, Pisano S, Viggiano A, Verrotti A. Mozart's music in children with drug-refractory epileptic encephalopathies. Epilepsy Behav. 2015 Sep;50:18-22. doi: 10.1016/j.yebeh.2015.05.038. Epub 2015 Jun 18.
- Jenkins JS. The Mozart effect. J R Soc Med. 2001 Apr;94(4):170-2. doi: 10.1177/014107680109400404. No abstract available.
- Goines L, Hagler L. Noise pollution: a modem plague. South Med J. 2007 Mar;100(3):287-94. doi: 10.1097/smj.0b013e3180318be5.
- Hsu, T., Ryherd, E. E., Waye, K. P., & Ackerman, J. (2012). Noise pollution in hospitals: Impact on patients. Journal of Clinical Outcomes Management, 19(7), 301-309.
- Gupta A, Gupta A, Jain K, Gupta S. Noise Pollution and Impact on Children Health. Indian J Pediatr. 2018 Apr;85(4):300-306. doi: 10.1007/s12098-017-2579-7. Epub 2018 Jan 9.
- Xyrichis A, Wynne J, Mackrill J, Rafferty AM, Carlyle A. Noise pollution in hospitals. BMJ. 2018 Nov 18;363:k4808. doi: 10.1136/bmj.k4808. No abstract available.
- Stansfeld S, Clark C. Health Effects of Noise Exposure in Children. Curr Environ Health Rep. 2015 Jun;2(2):171-8. doi: 10.1007/s40572-015-0044-1.
- Kramer B, Joshi P, Heard C. Noise pollution levels in the pediatric intensive care unit. J Crit Care. 2016 Dec;36:111-115. doi: 10.1016/j.jcrc.2016.06.029. Epub 2016 Jul 9.
- Ryan KM, Gagnon M, Hanna T, Mello B, Fofana M, Ciottone G, Molloy M. Noise Pollution: Do We Need a Solution? An Analysis of Noise in a Cardiac Care Unit. Prehosp Disaster Med. 2016 Aug;31(4):432-5. doi: 10.1017/S1049023X16000388. Epub 2016 May 23.
- Linares C, Diaz J, Tobias A, De Miguel JM, Otero A. Impact of urban air pollutants and noise levels over daily hospital admissions in children in Madrid: a time series analysis. Int Arch Occup Environ Health. 2006 Feb;79(2):143-52. doi: 10.1007/s00420-005-0032-0. Epub 2005 Sep 27.
- Eze IC, Foraster M, Schaffner E, Vienneau D, Heritier H, Pieren R, Thiesse L, Rudzik F, Rothe T, Pons M, Bettschart R, Schindler C, Cajochen C, Wunderli JM, Brink M, Roosli M, Probst-Hensch N. Transportation noise exposure, noise annoyance and respiratory health in adults: A repeated-measures study. Environ Int. 2018 Dec;121(Pt 1):741-750. doi: 10.1016/j.envint.2018.10.006. Epub 2018 Oct 12.
- Brown G. NICU noise and the preterm infant. Neonatal Netw. 2009 May-Jun;28(3):165-73. doi: 10.1891/0730-0832.28.3.165.
- Wachman EM, Lahav A. The effects of noise on preterm infants in the NICU. Arch Dis Child Fetal Neonatal Ed. 2011 Jul;96(4):F305-9. doi: 10.1136/adc.2009.182014. Epub 2010 Jun 14.
- McCallum GB, Morris PS, Wilson CC, Versteegh LA, Ward LM, Chatfield MD, Chang AB. Severity scoring systems: are they internally valid, reliable and predictive of oxygen use in children with acute bronchiolitis? Pediatr Pulmonol. 2013 Aug;48(8):797-803. doi: 10.1002/ppul.22627. Epub 2012 Sep 4.
- W. J. Dixon. BMDP Statistical Software. 1993.
- Guski R, Schreckenberg D, Schuemer R. WHO Environmental Noise Guidelines for the European Region: A Systematic Review on Environmental Noise and Annoyance. Int J Environ Res Public Health. 2017 Dec 8;14(12):1539. doi: 10.3390/ijerph14121539.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de febrero de 2018
Finalización primaria (Actual)
28 de febrero de 2019
Finalización del estudio (Actual)
31 de enero de 2021
Fechas de registro del estudio
Enviado por primera vez
29 de marzo de 2021
Primero enviado que cumplió con los criterios de control de calidad
4 de abril de 2021
Publicado por primera vez (Actual)
6 de abril de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
4 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0755-17
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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