Short-term Effects of Live Music in Preterm Infants

Prematurity Clinical Trial

— MTN05  

Official title:

Short-term Effects of Live Pentatonic Music on Physiological Parameters in Preterm Infants - A Randomized Controlled Trial With Crossover Design

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908244
• Other study ID #: ARCIM_MTN05
• Status: Completed
• Phase: N/A
• First received: July 23, 2013
• Last updated: October 22, 2013
• Start date: July 2013

Study information

• Verified date: July 2013
• Source: ARCIM Institute Academic Research in Complementary and Integrative Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 26 Weeks to 34 Weeks

Eligibility

Inclusion Criteria:

• Gestational age 26-34 weeks; no use of CPAP (Continous Positive Airway Pressure) or any other form of mechanical ventilation; signed informed consent of the parents

Exclusion Criteria:

• Heart defect or known cardiac arrhythmia; other diseases of the preterm and newborn period (including infections and chromosomal aberrations) which make an additional diagnostic and therapeutic intervention unacceptable; detection of deafness (TEOAE, transitory evoked otoacoustic emission)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prematurity

Intervention

Other:
• Music
Pentatonic music

Locations

Country	Name	City	State
Germany	Filderklinik	Filderstadt	Baden-Württemberg
Germany	Universtitätsklinikum für Kinder und Jugendmedizin, Abteilung IV Neonatologie	Tuebingen	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
ARCIM Institute Academic Research in Complementary and Integrative Medicine	University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Arnon S, Shapsa A, Forman L, Regev R, Bauer S, Litmanovitz I, Dolfin T. Live music is beneficial to preterm infants in the neonatal intensive care unit environment. Birth. 2006 Jun;33(2):131-6. — View Citation

Standley JM. A meta-analysis of the efficacy of music therapy for premature infants. J Pediatr Nurs. 2002 Apr;17(2):107-13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of desaturations < 90% per hour		physiological parameters are measured twice over a period of 2 hours and 15 minutes	No
Secondary	DI < 85% (Desaturations <85%/hour)		Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	No
Secondary	DI < 80% (Desaturations <80% per hour)		Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	No
Secondary	Heart rate		Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	No
Secondary	Oxygen saturation		Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	No
Secondary	Apnoea > 4 sec /h		Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	No
Secondary	Bradycardia < 80 bpm/h		Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	No
Secondary	Tachycardia > 200 bmp/h		Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	No
Secondary	HRV-Parameters	SDNN, RMSSD, pNN50, LF/HF	Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	No
Secondary	PI	Perfusionindex	Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	No
Secondary	PTT	Pulse-Transit-Time (ms)	Physiological parameters are measured twice over a period of 2 hours and 15 minutes.	No
Secondary	State Trait Anxiety Inventory		If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention	No
Secondary	State of the child		If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention	No
Secondary	additional music questions		If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention	No