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

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT04009655
Collaborator
(none)
45
1
2
4
11.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: music
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
Actual Study Start Date :
Aug 15, 2019
Actual Primary Completion Date :
Dec 15, 2019
Actual Study Completion Date :
Dec 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: music therapy

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

Other: music
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

Outcome Measures

Primary Outcome Measures

  1. change of brain oxygen saturation [from the start of the intervention to the end of the 3rd day]

    near-infrared spectroscopy to monitor brain oxygen saturation

Secondary Outcome Measures

  1. Burdjalov Scores of amplitude integrated electroencephalogram [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.

  2. change of heart rates [from the start of the intervention to the end of the 3rd day]

    monitors recording heart rates

  3. change of respiratory rates [from the start of the intervention to the end of the 3rd day]

    monitors recording respiratory rates

  4. change of pluse oxygen saturation [from the start of the intervention to the end of the 3rd day]

    monitors recording transcutaneous oxygen saturation

Eligibility Criteria

Criteria

Ages Eligible for Study:
224 Days to 258 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Fudan University Shanghai Shanghai China 201102

Sponsors and Collaborators

  • Children's Hospital of Fudan University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Children's Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT04009655
Other Study ID Numbers:
  • MTOBF
First Posted:
Jul 5, 2019
Last Update Posted:
May 11, 2020
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2020