Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study
2 other identifiers
interventional
200
1 country
6
Brief Summary
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
May 11, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 24, 2025
February 1, 2025
8.2 years
May 11, 2018
February 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Heart Rate
up to 2 weeks
Respiratory Rate
up to 2 weeks
O2 sats
Oxygen saturation levels (O2 sats)
up to 2 weeks
Activity level
The neonatologist or nurse will assess and mark as active/alert, active to stimulation, flaccid, hypertonic, hypotonic, irritable, jittery, lethargic, paralyzed\&medicated, quiet, sedated, or tremors
up to 2 weeks
Sleep category
The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying.
up to 2 weeks
Feeding (sucking and absorption) category
The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage)
up to 2 weeks
Neonatal Abstinence Scoring (NAS)
The NAS score lists 21 symptoms that are most frequently observed in opiate-exposed infants. Each symptom and its associated degree of severity are assigned a score and the total abstinence score is determined by totalling the score assigned to each symptom over the scoring period. Please provide the full scale info (example 0 (no symptoms) to 10 (severe symptoms)
up to 2 weeks
Secondary Outcomes (1)
Postpartum Bonding Questionnaire (PBQ )
Baseline
Study Arms (6)
Song of Kin
EXPERIMENTALVoice (with or without guitar)- lullaby/ Holding meter
Gato box
EXPERIMENTALSimple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate
Ocean disc
EXPERIMENTALCreating a consistent womb-like sound soundscape to comfort, engage or sedate
Contingent singing
EXPERIMENTALProvision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)
Tonal Vocal holding
EXPERIMENTALProviding a 'blanket of tone' to comfort, engage or sedate
Muted shaker
EXPERIMENTALIf infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Interventions
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.
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
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.
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
Music therapist will provide a vowel, long held tone, sung without vibrato
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Eligibility Criteria
You may qualify if:
- Admitted to the NICU immediately postpartum
- 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)
You may not qualify if:
- Admitted to the NICU at any time other than immediately postpartum
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Tulane University Hospital
New Orleans, Louisiana, 70112, United States
Joseph M. Sanzari Children's Hospital
Hackensack, New Jersey, 07601, United States
Northwell Health
New Hyde Park, New York, 11040, United States
Mount Sinai West
New York, New York, 10003, United States
Maria Fareri Children's Hospital
Valhalla, New York, 10595, United States
Drexel University/Hahnemann Hospital-College of Nursing and Health Professions
Philadelphia, Pennsylvania, 19102, United States
Related Publications (4)
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.
PMID: 23589814BACKGROUNDLoewy 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.
PMID: 25773633BACKGROUNDBieleninik 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.
PMID: 27561729BACKGROUNDPahl 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.
PMID: 33348423DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanne Loewy, PhD
Icahn School of Medicine at Mount Sinai
- PRINCIPAL INVESTIGATOR
Kathy Murphy, PhD
Loyola University
- STUDY DIRECTOR
Aimee Telsey, MD
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Parents of infants will be unaware of the interventions' effects. Outcomes Assessor will be unfamiliar with desired outcomes.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Louis Armstrong Center for Music and Medicine at Mount Sinai Beth Israel
Study Record Dates
First Submitted
May 11, 2018
First Posted
May 23, 2018
Study Start
November 1, 2017
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
February 24, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share