Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Song of Kin, Gato box, Ocean disc, Contingent singing.
- Who it may be relevant to
- Registry conditions: NAS. Basic parameters: from 28 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study
Overview
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
Detailed description
The purpose of this exploratory pilot study is to learn what, if any, effects live music therapy interventions have on the pacification, stabilization, and development of infants diagnosed with Neonatal Abstinence Syndrome (NAS). Neonatal Abstinence Syndrome is a group of problems that occur in a newborn who has been exposed to illegal or prescription opiates while in the mother's womb. Participants will receive 6 music therapy sessions over a 14-day period based on a randomized treatment schedule of 6 different interventions.
Interventions
- Behavioral 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. - Other 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 - Other 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. - Other 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 - Other Tonal Vocal holding
Music therapist will provide a vowel, long held tone, sung without vibrato - Other 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
Primary outcome measures
- Heart Rate [Time frame: up to 2 weeks]
- Respiratory Rate [Time frame: up to 2 weeks]
- O2 sats [Time frame: up to 2 weeks]
- Activity level [Time frame: up to 2 weeks]
- Sleep category [Time frame: up to 2 weeks]
- Feeding (sucking and absorption) category [Time frame: up to 2 weeks]
- Neonatal Abstinence Scoring (NAS) [Time frame: up to 2 weeks]
Secondary outcome measures (1)
- Postpartum Bonding Questionnaire (PBQ ) [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
Infants who meet the following inclusion criteria will be eligible to participate in the study irrespective of race, religion, ethnicity, or gender:
- 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)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Tulane University Hospital — New Orleans
- Joseph M. Sanzari Children's Hospital — Hackensack
- Northwell Health — New Hyde Park
- Mount Sinai West — New York
- Maria Fareri Children's Hospital — Valhalla
- Drexel University/Hahnemann Hospital-College of Nursing and Health Professions — Philadelphia
Publications
- 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 23589814
- 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. PMID 25773633
- 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. PMID 27561729
- 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. PMID 33348423
Identifiers
NCT: NCT03533985 · GCO 16-1991 · IRB 16-00740