The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- change of brain oxygen saturation
Study Overview
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.
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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 224 Days to 258 Days (Child)
- Sex
- 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.
Arms & Interventions
music therapy
The infant will receive music therapy over 3 consecutive days and will obtain standard care as usual
Intervention: music (Other)
control
The infant does not receive any sound emission because the headphone will be turned off and will obtain standard care as experimental
Outcomes
Primary Outcomes
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
Secondary Outcomes
- change of respiratory rates(from the start of the intervention to the end of the 3rd day)
- Burdjalov Scores of amplitude integrated electroencephalogram(from the start of the intervention to the end of the 3rd day)
- change of heart rates(from the start of the intervention to the end of the 3rd day)
- change of pluse oxygen saturation(from the start of the intervention to the end of the 3rd day)