The effect of Mozart's sonata for two pianos in D-major (K. 448) on the heart rate and overall monitoring of premature babies in the NICU

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031524

Enrollment

Registered

2024-03-13

Start date

2023-11-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P07.3

Interventions

Group 1: Intervention group: Mozart K. 448 The participants listen to the sonata K. 448 (duration: approx. 25 min) once only. For a time span of 55 minutes (15 minutes without music, 25 minutes with

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age of minimum 72 hours, parent signed declaration of consent

Exclusion criteria

Exclusion criteria: Infection, sepsis, intraventricular hemorrhage, congenital malformations, seizures, oxygen demand, hyperbilirubinemia, invasive ventilation, abnormal auditory screening

Design outcomes

Primary

Measure	Time frame
The primary outcome is defined as difference in heart rate in beats per minute. The mean difference will be calculated by forming the difference of the mean heart rate during the 15-minute observation period before and the mean heart rate during the 15-minute observation period after the intervation (or 25-min observation period). The heart rate will be measured constantly via connected monitoring and will be written down into a chart every 2 minutes.	—

Measure

Time frame

The primary outcome is defined as difference in heart rate in beats per minute. The mean difference will be calculated by forming the difference of the mean heart rate during the 15-minute observation period before and the mean heart rate during the 15-minute observation period after the intervation (or 25-min observation period). The heart rate will be measured constantly via connected monitoring and will be written down into a chart every 2 minutes.

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Secondary

Measure	Time frame
Further parameters: blood pressure, oxygen saturation, respiratory rate, number of apnea phases Blood pressure: Measured twice: at 7 minutes and 47 minutes via blood pressure monitor. The blood pressure will be notated in a chart. Oxygen saturation: Is being measured constantly. Will be written down in a chart every 2 minutes. Respiratory rate: Is being measured constantly. Will be written down in a chart every 2 minutes. Number of apnea phases: Constant observation of the according participant and their oxygen saturation. A aprupt reduction of saturation together with grunting-noises indicate an apnea phase. It will subsequently be notated in a chart.	—

Measure

Time frame

Further parameters: blood pressure, oxygen saturation, respiratory rate, number of apnea phases Blood pressure: Measured twice: at 7 minutes and 47 minutes via blood pressure monitor. The blood pressure will be notated in a chart. Oxygen saturation: Is being measured constantly. Will be written down in a chart every 2 minutes. Respiratory rate: Is being measured constantly. Will be written down in a chart every 2 minutes. Number of apnea phases: Constant observation of the according participant and their oxygen saturation. A aprupt reduction of saturation together with grunting-noises indicate an apnea phase. It will subsequently be notated in a chart.

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Countries

Germany

Contacts

Public ContactIna Wechsler

Universitätsklinik und Poliklinik für Pädiatrie II, Universitätsklinikum Halle

ina.wechsler@uk-halle.de0049 345 557 2611

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026