- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04833686
The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Petach Tikva, Izrael, 4920235
- Schneider Children's Medical Center of Israel
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Aktywny komparator: 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.
|
Music composed by Mozart, a musical piece 24 minutes long.
|
Aktywny komparator: 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.
|
Instrumental music , a musical piece 24 minutes long
|
Aktywny komparator: Silence
An Mp3 player, upload with silence.
Silence was played using headphones suitable and approved for use in children.
|
Silence, a piece 24 minutes long.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Change in disease severity
Ramy czasowe: 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).
|
Evaluated by Modified Tal Score (Respiratory rate, O2 saturation, use of accessory respiratory muscles, breath sounds: wheezing)
|
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).
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Noa Ziv, MD, Schneider Children's Medical Center, Israel
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 0755-17
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Mozart
-
Federal University of Minas GeraisZakończonyZachowanie dzieci
-
Medical University of South CarolinaZakończonyPadaczka | Drgawki | Padaczka Rolanda | Łagodna padaczka dziecięca z kolcami centralno-skroniowymiStany Zjednoczone