Newborn Infant
Conditions
Keywords
Infant, Newborn, Music
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.
Interventions
OTHERMusic
Live music played on the pentatonically tuned children's harp
Sponsors
University Hospital Tuebingen
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Weeks to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| heartrate | physiological parameters are measured twice over a period of 45 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
| Oxygen saturation | 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). | — |
| Perfusion Index (PI) | physiological parameters are measured twice over a period of 45 minutes | — |
Countries
Germany
Outcome results
None listed