Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT03533985
Status
Recruiting

Conditions

  • NAS

Eligibility Criteria

Sex
ALL
Age
28 Weeks - N/A
Healthy Volunteers
Not accepted

Interventions

  • Song of Kin — BEHAVIORAL
    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 — OTHER
    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 — OTHER
    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 — OTHER
    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 — OTHER
    Music therapist will provide a vowel, long held tone, sung without vibrato
  • Muted shaker — OTHER
    If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate

Study Details

This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.

Key Dates

Start date
Nov 1, 2017
Status verified
Feb 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Song of Kin
    Voice (with or without guitar)- lullaby/ Holding meter
  • Experimental: Gato box
    Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate
  • Experimental: Ocean disc
    Creating a consistent womb-like sound soundscape to comfort, engage or sedate
  • Experimental: Contingent singing
    Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)
  • Experimental: Tonal Vocal holding
    Providing a 'blanket of tone' to comfort, engage or sedate
  • Experimental: 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 Measure

Heart Rate [ Time Frame: up to 2 weeks ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Tulane University HospitalNew OrleansLouisiana70112
Meghan Howell, MD, FAAP
504-988-4158
Rachel Lee, MD
Stacy Drury, MD, PhD (PRINCIPAL_INVESTIGATOR)
Joseph M. Sanzari Children's HospitalHackensackNew Jersey07601
Naoko Mizutani, MA
551-996-2714
Ellen Goldring
551-996-5146
Ellen Goldring, MA (SUB_INVESTIGATOR)
Northwell HealthNew Hyde ParkNew York11040
Greg Razzano, MA
(718) 470-3000
Shawna Vernisie, MA
718 470-3002
Shawna Vernisie, MA (SUB_INVESTIGATOR)
Mount Sinai WestNew YorkNew York10003
Ann Marie Dassler, NP
973 986 6306
Aimee Telsey, MD
212 844-8387
Jasmine Edwards, MA (SUB_INVESTIGATOR)
Maria Fareri Children's HospitalValhallaNew York10595
Laurie Park, MA
914-493-7000
Lance Parton, MD
(914) 493-6640
Laurie Park, MA (SUB_INVESTIGATOR)
Drexel University/Hahnemann Hospital-College of Nursing and Health ProfessionsPhiladelphiaPennsylvania19102
Flossie Ierardi, MA
(267) 359-5501
Scott Horwitz, MA
(267) 359-5572
Flossie Ierardi, MA (SUB_INVESTIGATOR)

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