Short-term Effects of Live Music in Preterm Infants (MTN05)

October 22, 2013 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine

Short-term Effects of Live Pentatonic Music on Physiological Parameters in Preterm Infants - A Randomized Controlled Trial With Crossover Design

The purpose of this study is to determine the effects of pentatonic live music on physiological parameters in preterm infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

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
      • Tuebingen, Baden-Württemberg, Germany, 72076
        • Universtitätsklinikum für Kinder und Jugendmedizin, Abteilung IV Neonatologie

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

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gestational age 26-34 weeks; no use of CPAP (Continous Positive Airway Pressure) or any other form of mechanical ventilation; signed informed consent of the parents

Exclusion Criteria:

  • Heart defect or known cardiac arrhythmia; other diseases of the preterm and newborn period (including infections and chromosomal aberrations) which make an additional diagnostic and therapeutic intervention unacceptable; detection of deafness (TEOAE, transitory evoked otoacoustic emission)

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music
Other: Music
Pentatonic music
No Intervention: Control
No pentatonic music

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numbers of desaturations < 90% per hour
Time Frame: physiological parameters are measured twice over a period of 2 hours and 15 minutes
physiological parameters are measured twice over a period of 2 hours and 15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DI < 85% (Desaturations <85%/hour)
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
DI < 80% (Desaturations <80% per hour)
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Heart rate
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Oxygen saturation
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Apnoea > 4 sec /h
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Bradycardia < 80 bpm/h
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Tachycardia > 200 bmp/h
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
HRV-Parameters
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
SDNN, RMSSD, pNN50, LF/HF
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
PI
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Perfusionindex
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
PTT
Time Frame: Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
Pulse-Transit-Time (ms)
Physiological parameters are measured twice over a period of 2 hours and 15 minutes.
State Trait Anxiety Inventory
Time Frame: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
State of the child
Time Frame: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
additional music questions
Time Frame: If present questionnaires are filled in by the child's mother before and after the music intervention respectively no intervention
If present questionnaires are filled in by the child's mother before and after the music intervention respectively no 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

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)

October 1, 2013

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

October 23, 2013

Last Update Submitted That Met QC Criteria

October 22, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARCIM_MTN05

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.

Clinical Trials on Prematurity

Clinical Trials on Music

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe