Study Results
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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TERMINATED
NA
102 participants
INTERVENTIONAL
2020-10-15
2025-01-30
Brief Summary
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Detailed Description
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We aim in this study to find out if the oriental music exposure in preterm infants improves babies' heart rate variability, physiological parameters and behavior state during their NICU stay.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Oriental music
Infants assigned to this group will be exposed to oriental music.
Music exposure
Participants will be offered individual sessions of music. They will be exposed for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.
Western music
Infants assigned to this group will be exposed to western music.
Music exposure
Participants will be offered individual sessions of music. They will be exposed for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.
Silence / control
Infants assigned to this group will be exposed to the same protocol but using a track of silence.
Silence
Participants in this group will be offered individual silence session for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.
Interventions
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Music exposure
Participants will be offered individual sessions of music. They will be exposed for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.
Silence
Participants in this group will be offered individual silence session for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Infants planned to stay in the NICU for at least 2 weeks at the time of enrollment.
Exclusion Criteria
* Receiving medications that might interfere with heart rate and reaction to music exposure such as midazolam or morphine.
14 Days
28 Days
ALL
Yes
Sponsors
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American University of Beirut Medical Center
OTHER
Responsible Party
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Principal Investigators
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Lama Charafeddine, MD
Role: PRINCIPAL_INVESTIGATOR
American University of Beirut Medical Center
Locations
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American University of Beirut
Beirut, , Lebanon
Countries
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Other Identifiers
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SBS-2020-0284
Identifier Type: -
Identifier Source: org_study_id
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