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

NCT ID: NCT04009655

Last Updated: 2020-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-15

Study Completion Date

2019-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Preterm Infant Music Near-infrared Spectroscopy Electroencephalogram

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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music therapy

The infant will receive music therapy over 3 consecutive days and will obtain standard care as usual

Group Type EXPERIMENTAL

music

Intervention Type OTHER

music selected by musician

control

The infant does not receive any sound emission because the headphone will be turned off and will obtain standard care as experimental

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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music

music selected by musician

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

224 Days

Maximum Eligible Age

258 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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lai s wang, Ph.D

Role: STUDY_DIRECTOR

Children's Hospital of Fudan University

Locations

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Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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MTOBF

Identifier Type: -

Identifier Source: org_study_id

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