Short Term Effects of Live Music in Newborn Infants

January 22, 2014 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Filderstadt, Baden-Württemberg, Germany, 70794
        • Filderklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation
Time Frame: physiological parameters are measured twice over a period of 45 minutes.
physiological parameters are measured twice over a period of 45 minutes.
Breathing rate
Time Frame: physiological parameters are measured twice over a period of 45 minutes
physiological parameters are measured twice over a period of 45 minutes
Apnoea > 4 sec per hour
Time Frame: physiological parameters are measured twice over a period of 45 minutes
physiological parameters are measured twice over a period of 45 minutes
Bradycardia < 80 bpm/h
Time Frame: physiological parameters are measured twice over a period of 45 minutes
physiological parameters are measured twice over a period of 45 minutes
Tachycardia > 200 bmp/h
Time Frame: physiological parameters are measured twice over a period of 45 minutes
physiological parameters are measured twice over a period of 45 minutes
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)
physiological parameters are measured twice over a period of 45 minutes
Perfusion Index (PI)
Time Frame: physiological parameters are measured twice over a period of 45 minutes
physiological parameters are measured twice over a period of 45 minutes
Pulse-Transit-Time (PTT)
Time Frame: physiological parameters are measured twice over a period of 45 minutes
physiological parameters are measured twice over a period of 45 minutes
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).
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
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).
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
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).
The additional music questions are filled in by the child's mother after the music intervention (during the15 minutes directly after the music intervention).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARCIM Institute Academic Research in Complementary and Integrative Medicine

Collaborators

University Hospital Tuebingen

Investigators

  • Principal Investigator: Jan Vagedes, Dr., ARCIM-Institute; University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 29, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Estimate)

January 23, 2014

Last Update Submitted That Met QC Criteria

January 22, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ARCIM_MTN04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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