Short Term Effects of Live Music in Newborn Infants

Not Applicable

Completed

• Conditions: Newborn Infant
• Interventions: Other: Music

• Registration Number: NCT01914341
• Lead Sponsor: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-22
• Last Update Posted: 2014-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Music	Music	pentatonic live music

Primary Outcome Measures

Name	Time	Method
heartrate	physiological parameters are measured twice over a period of 45 minutes

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation	physiological parameters are measured twice over a period of 45 minutes.
Bradycardia < 80 bpm/h	physiological parameters are measured twice over a period of 45 minutes
Tachycardia > 200 bmp/h	physiological parameters are measured twice over a period of 45 minutes
heart rate variability-parameters (HRV)	physiological parameters are measured twice over a period of 45 minutes	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)
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).
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).
Breathing rate	physiological parameters are measured twice over a period of 45 minutes
Apnoea > 4 sec per hour	physiological parameters are measured twice over a period of 45 minutes
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).
Perfusion Index (PI)	physiological parameters are measured twice over a period of 45 minutes
Pulse-Transit-Time (PTT)	physiological parameters are measured twice over a period of 45 minutes

Trial Locations

Locations (1)

Filderklinik; 🇩🇪 Filderstadt, Baden-Württemberg, Germany