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Impact of monochord music therapy on heart rate variability and apneas of very low birthweight preterm infants

Impact of monochord music therapy on heart rate variability and apneas of very low birthweight preterm infants

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040367
Enrollment
42
Registered
2026-05-22
Start date
2026-03-08
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

P07

Interventions

Group 1: It is an interventional, intra-individual comparative study. Each child receives music therapy using a monochord three times, for 20 minutes per session, at one-week intervals. Vital paramete

Sponsors

Medizinische Fakultät der Universität Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Days to 30 Days

Inclusion criteria

Inclusion criteria: -Prematurity at less than 30 + 0 weeks of gestation -Birth weight between 500 and 1500 grams -The neonate must be able to breathe spontaneously for the duration of the data collection. -Parental consent must be obtained

Exclusion criteria

Exclusion criteria: -Patients with severe malformations (severe cardiac defects requiring surgery, severe neurological malformations, gastrointestinal malformations and malformations of the abdominal wall and diaphragm, pulmonary malformations leading to severe respiratory impairment) -Patients requiring invasive ventilation -(Secondary) exclusion of patients with an abnormal BERA result or other indications of severely diminished or absent hearing -Secondary exclusion occurs in the event of a significant protocol violation—for example, if less than 70% (i.e., less than 14 minutes) of a scheduled music therapy session was conducted

Design outcomes

Primary

MeasureTime frame
Measurement of heart rate variability during the 24 hours prior to the intervention, the 20 minutes during the intervention, and the 24 hours following it, using 3 canal ECG and the Philips IntelliVue monitors in the Neonatal Intensive Care Unit

Secondary

MeasureTime frame
Measurement of apnea frequency (frequency of respiratory pauses) over 24 hours prior to the intervention, 20 minutes during the intervention, and 24 hours thereafter, using the saturation sensor (Sp02 measurement) and the Philips IntelliVue monitors in the Neonatal Intensive Care Unit

Countries

Germany

Contacts

Public ContactUlrich Thome

Universitätsklinikum Leipzig

ulrich.thome@medizin.uni-leipzig.de0341 - 97 26020

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026