Recruiting

Music TherapyEffect of Music Therapy on Infants With Neonatal Abstinence Syndrome

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT03533985

Conditions

NAS

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Song of Kin

Gato box

Ocean disc

Contingent singing

Tonal Vocal holding

Study Details

Brief summary:

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

Conditions

NAS

Study ID

NCT03533985

Start date

Nov 1, 2017

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Joanne Loewy, DA, LCAT, MT-BC

212-420-3484 joanne.loewy@mountsinai.org

Elizabeth Barone, MA, MT-BC, CCLS

Elizabeth.Barone@mountsinai.org

Locations

Tulane University Hospital

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Meghan Howell, MD, FAAP

504-988-4158 mhowell2@tulane.edu

Rachel Lee, MD

rlee13@tulane.edu

Principal Investigator:

Stacy Drury, MD, PhD

Joseph M. Sanzari Children's Hospital

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Naoko Mizutani, MA

551-996-2714 Naoko.Mizutani@hackensackmeridian.org

Ellen Goldring

551-996-5146 Naoko.Mizutani@hackensackmeridian.org

Northwell Health

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Greg Razzano, MA

(718) 470-3000 grazzano@northwell.edu

Shawna Vernisie, MA

718 470-3002 svernisie@northwell.edu

Mount Sinai West

Recruiting

New York, New York, United States, 10003

Contacts

Ann Marie Dassler, NP

973 986 6306 amdassler@yahoo.com

Aimee Telsey, MD

212 844-8387 amthome@gmail.com

Maria Fareri Children's Hospital

Recruiting

Valhalla, New York, United States, 10595

Contacts

Laurie Park, MA

914-493-7000

Lance Parton, MD

(914) 493-6640 lanceaparton@yahoo.com

Drexel University/Hahnemann Hospital-College of Nursing and Health Professions

Recruiting

Philadelphia, Pennsylvania, United States, 19102

Contacts

Flossie Ierardi, MA

(267) 359-5501 sah46@drexel.edu

Scott Horwitz, MA

(267) 359-5572 fmi22@drexel.edu

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 22, 2026

Last verified

Mar, 2026

Keywords

Neonatal Abstinence Syndrome
Music therapy
Attachment
Music medicine
Multi-modal stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-07-22.