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Completed

NCT Number: NCT01914341

Short Term Effects of Live Music in Newborn Infants

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.

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Key information

Conditions

Newborn Infant

Age range

35 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Filderklinik

Filderstadt, Baden-Wurttemberg, 70794, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

Live music played on the pentatonically tuned children's harp

Primary outcomes

  1. heartrate

    Time frame: physiological parameters are measured twice over a period of 45 minutes

Secondary outcomes

  1. Oxygen saturation

    Time frame: physiological parameters are measured twice over a period of 45 minutes.

  2. Breathing rate

    Time frame: physiological parameters are measured twice over a period of 45 minutes

  3. Apnoea > 4 sec per hour

    Time frame: physiological parameters are measured twice over a period of 45 minutes

  4. Bradycardia < 80 bpm/h

    Time frame: physiological parameters are measured twice over a period of 45 minutes

  5. Tachycardia > 200 bmp/h

    Time frame: physiological parameters are measured twice over a period of 45 minutes

  6. heart rate variability-parameters (HRV)

    Time frame: 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)

  7. Perfusion Index (PI)

    Time frame: physiological parameters are measured twice over a period of 45 minutes

  8. Pulse-Transit-Time (PTT)

    Time frame: physiological parameters are measured twice over a period of 45 minutes

  9. State Trait Anxiety Inventory

    Time frame: 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).

  10. State of the child

    Time frame: 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).

  11. Additional music questions

    Time frame: The additional music questions are filled in by the child's mother after the music intervention (during the15 minutes directly after the music intervention).

Sponsors and collaborators

Lead sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Other

Collaborators

  • University Hospital Tuebingen

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2013
Registry last updated
Jan 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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