Short Term Effects of Live Music in Newborn Infants

Study Overview
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Brief Summary
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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.

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

Conditions
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Newborn Infant

Intervention / Treatment
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* Other: Music


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music<br>pentatonic live music | Other: Music<br>* Live music played on the pentatonically tuned children's harp<br>|
| No Intervention: control<br>no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heartrate |  | physiological parameters are measured twice over a period of 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen saturation |  | physiological parameters are measured twice over a period of 45 minutes. | 
| 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 | 
| 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) | 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 | 
| 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 | 
| 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). | 
| 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Newborn, Music