Short Term Effects of Live Music in Newborn Infants

Newborn Infant Clinical Trial

Official title:

Short-term Effects of Live Pentatonic Music on Physiological Parameters in Newborns Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01914341
• Other study ID #: ARCIM_MTN04
• Status: Completed
• Phase: N/A
• First received: July 29, 2013
• Last updated: January 22, 2014
• Start date: July 2013
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• 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 live music on physiological parameters in newborn infants. The mother is asked about the effects of music on her own and the child's wellbeing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Weeks and older

Eligibility

Inclusion Criteria:

• Gestational age = 35 weeks

• signed informed consent of the parents

• positive proof of hearing ability (TEOAE, transitory evoked otoacoustic emission)

• positive 10-minute Apgar-Score > 7

Exclusion Criteria:

• Heart defect or known cardiac arrhythmia

• other diseases of the preterm and newborn period (including infections and chromosomal aberrations)

• participation in other studies

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Newborn Infant

Intervention

Other:
• Music
Live music played on the pentatonically tuned children's harp

Locations

Country	Name	City	State
Germany	Filderklinik	Filderstadt	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 (3)

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

Bo LK, Callaghan P. Soothing pain-elicited distress in Chinese neonates. Pediatrics. 2000 Apr;105(4):E49. — 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	heartrate		physiological parameters are measured twice over a period of 45 minutes	No
Secondary	Oxygen saturation		physiological parameters are measured twice over a period of 45 minutes.	No
Secondary	Breathing rate		physiological parameters are measured twice over a period of 45 minutes	No
Secondary	Apnoea > 4 sec per hour		physiological parameters are measured twice over a period of 45 minutes	No
Secondary	Bradycardia < 80 bpm/h		physiological parameters are measured twice over a period of 45 minutes	No
Secondary	Tachycardia > 200 bmp/h		physiological parameters are measured twice over a period of 45 minutes	No
Secondary	heart rate variability-parameters (HRV)	RMSS (root mean square of successive differences) SDNN (standard deviation of normal to normal intervals) pNN50 (the proportion of NN50 (the number of pairs of successive NNs that differ by more than 50 ms) divided by total number of NNs) LF/HF (low frequency/high frequency)	physiological parameters are measured twice over a period of 45 minutes	No
Secondary	Perfusion Index (PI)		physiological parameters are measured twice over a period of 45 minutes	No
Secondary	Pulse-Transit-Time (PTT)		physiological parameters are measured twice over a period of 45 minutes	No
Secondary	State Trait Anxiety Inventory		Questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention (during the first and during the last 15 minutes of the physiological measurement).	No
Secondary	State of the child		Questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention (during the first and during the last 15 minutes of the physiological measurement).	No
Secondary	Additional music questions		The additional music questions are filled in by the child's mother after the music intervention (during the15 minutes directly after the music intervention).	No