Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
NCT ID: NCT03533985
Last Updated: 2025-02-24
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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RECRUITING
NA
200 participants
INTERVENTIONAL
2017-11-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Song of Kin
Voice (with or without guitar)- lullaby/ Holding meter
Song of Kin
Music therapists will assess meaningful song/theme (of choice/culture) and provide musical elements in a way that nurtures parents. They will then develop a simplified part of the theme into a soothing lullaby for their infants to be utilized directly by the parent/s and/or the music therapist to comfort, engage or sedate.
Gato box
Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate
Gato box
Depending on the time of intervention and need of the infant the music therapist will provide rhythmic entrainment that follows the heart rate or suck patterns of the infant
Ocean disc
Creating a consistent womb-like sound soundscape to comfort, engage or sedate
Ocean disc
Depending on the time of intervention and needs of the infant the music therapist will provide a whoosh sound using the Remo Ocean disc. It will be entrained to the infant's respiratory rate.
Contingent singing
Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)
Contingent singing
Depending on the state of the infant, the music therapist will provide short segments of conversant prosody, to enhance quiet-alert, or stimulate relaxation/sleep
Tonal Vocal holding
Providing a 'blanket of tone' to comfort, engage or sedate
Tonal Vocal holding
Music therapist will provide a vowel, long held tone, sung without vibrato
Muted shaker
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Muted shaker
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Interventions
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Song of Kin
Music therapists will assess meaningful song/theme (of choice/culture) and provide musical elements in a way that nurtures parents. They will then develop a simplified part of the theme into a soothing lullaby for their infants to be utilized directly by the parent/s and/or the music therapist to comfort, engage or sedate.
Gato box
Depending on the time of intervention and need of the infant the music therapist will provide rhythmic entrainment that follows the heart rate or suck patterns of the infant
Ocean disc
Depending on the time of intervention and needs of the infant the music therapist will provide a whoosh sound using the Remo Ocean disc. It will be entrained to the infant's respiratory rate.
Contingent singing
Depending on the state of the infant, the music therapist will provide short segments of conversant prosody, to enhance quiet-alert, or stimulate relaxation/sleep
Tonal Vocal holding
Music therapist will provide a vowel, long held tone, sung without vibrato
Muted shaker
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Gestational age 28 weeks or older
* No identified hearing disorder
* Do not have a diagnosed developmental disability (i.e. Down Syndrome)
* Do not have Fetal Alcohol Syndrome
* Medically cleared to participate in the study by nurse or neonatologist
* Parent or legal guardian able/willing to give consent \& complete the PBQ (Postpartum Bonding Questionnaire)
Exclusion Criteria
* Gestational age \<28 weeks old
* Has an identified hearing disorder
* Has diagnosed developmental disability (i.e. Down syndrome)
* Has Fetal Alcohol Syndrome
* Is not medically cleared to participate in the study by the nurse or neonatologist
* Parent or legal guardian unable/unwilling to give consent
28 Weeks
ALL
No
Sponsors
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Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Joanne Loewy
Director, Louis Armstrong Center for Music and Medicine at Mount Sinai Beth Israel
Principal Investigators
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Joanne Loewy, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Kathy Murphy, PhD
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Aimee Telsey, MD
Role: STUDY_DIRECTOR
Icahn School of Medicine at Mount Sinai
Locations
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Tulane University Hospital
New Orleans, Louisiana, United States
Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, United States
Northwell Health
New Hyde Park, New York, United States
Mount Sinai West
New York, New York, United States
Maria Fareri Children's Hospital
Valhalla, New York, United States
Drexel University/Hahnemann Hospital-College of Nursing and Health Professions
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Laurie Park, MA
Role: primary
References
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Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
Loewy J. NICU music therapy: song of kin as critical lullaby in research and practice. Ann N Y Acad Sci. 2015 Mar;1337:178-85. doi: 10.1111/nyas.12648.
Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2.
Related Links
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Related Info
Other Identifiers
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IRB 16-00740
Identifier Type: OTHER
Identifier Source: secondary_id
GCO 16-1991
Identifier Type: -
Identifier Source: org_study_id
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