The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants

Music has been consistently shown magic power in brain plasticity. Several study proved music can influence electronic activity of preterm infants' brain, while none study covered region oxygen metabolic. The investigators aim to discover the effects of music therapy on near-infrared spectroscopy and electroencephalogram in premature infants.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Previous studies of music therapy have made some achievements for adult Parkinson's disease, schizophrenia, depression, anxiety, post-traumatic stress and pediatric autism spectrum disorders. For newborns, studies mainly focused on the effects of basic vital signs, feeding and pain score decreasing. So far, no studies evaluating the effect of music therapy on brain oxygen metabolic and electronic activity.

Study Type

Interventional

Enrollment (Actual)

45

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

    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University

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

7 months to 8 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Postmenstrual age of 32-36+6 weeks.
  • Appropriate weight for gestational age.
  • To have signed an informed consent to participate in the study.
  • Have reached clinical stability.

Exclusion Criteria:

  • Have nervous system diseases or obvious nervous system symptoms.
  • Severe congenital diseases.
  • The maintenance of sedative or analgesic drugs.
  • Support with mechanical ventilation.

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: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: music therapy
The infant will receive music therapy over 3 consecutive days and will obtain standard care as usual
music selected by musician
NO_INTERVENTION: control
The infant does not receive any sound emission because the headphone will be turned off and will obtain standard care as experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change of brain oxygen saturation
Time Frame: from the start of the intervention to the end of the 3rd day
near-infrared spectroscopy to monitor brain oxygen saturation
from the start of the intervention to the end of the 3rd day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burdjalov Scores of amplitude integrated electroencephalogram
Time Frame: from the start of the intervention to the end of the 3rd day
electroencephalogram to monitor brain electronic activity, using Burdjalov developed cerebral function monitoring scoring system which including: (1)record continuity: assessed through observing the overall density of the sample tracing, scores ranged from 0 to 2;(2) presence of cyclic changes:refers to the emergence and progression of periods during monitoring,scores ranged from 0 to 5;(3)degree of voltage amplitude depression:estimated as the average lower microvolt level during the recording epoch ,scores ranged from 0 to 2;(4)bandwidth:reflects a combination of the voltage span (peak-to-trough) of the tracing and the magnitude of the electroencephalogram depression,scores ranged from 0 to 4. The minimum possible total score was 0, and the maximum was 13. Scores progressively increased with central nerve system maturation.
from the start of the intervention to the end of the 3rd day
change of heart rates
Time Frame: from the start of the intervention to the end of the 3rd day
monitors recording heart rates
from the start of the intervention to the end of the 3rd day
change of respiratory rates
Time Frame: from the start of the intervention to the end of the 3rd day
monitors recording respiratory rates
from the start of the intervention to the end of the 3rd day
change of pluse oxygen saturation
Time Frame: from the start of the intervention to the end of the 3rd day
monitors recording transcutaneous oxygen saturation
from the start of the intervention to the end of the 3rd day

Collaborators and Investigators

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

Investigators

  • Study Director: lai s wang, Ph.D, Children's Hospital of Fudan University

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 (ACTUAL)

August 15, 2019

Primary Completion (ACTUAL)

December 15, 2019

Study Completion (ACTUAL)

December 15, 2019

Study Registration Dates

First Submitted

May 31, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (ACTUAL)

July 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2020

Last Update Submitted That Met QC Criteria

May 7, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • MTOBF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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