- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04009655
The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
May 7, 2020 updated by: Children's Hospital of Fudan University
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
Additional Relevant MeSH Terms
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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