Effect of Music Therapy on Infants with Neonatal Abstinence Syndrome

Mount Sinai Health System

Status: Enrolling

Conditions: NAS

Treatments: Other: Ocean disc; Other: Gato box; Behavioral: Song of Kin; Other: Tonal Vocal holding; Other: Muted shaker; Other: Contingent singing

Study type: Interventional

Funder types: Other

Identifiers

NCT03533985

GCO 16-1991

IRB 16-00740 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 28+ weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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200 participants in 6 patient groups

Song of Kin

Experimental group

Description:

Voice (with or without guitar)- lullaby/ Holding meter

Treatment:

Behavioral: Song of Kin

Gato box

Experimental group

Description:

Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate

Treatment:

Other: Gato box

Ocean disc

Experimental group

Description:

Creating a consistent womb-like sound soundscape to comfort, engage or sedate

Treatment:

Other: Ocean disc

Contingent singing

Experimental group

Description:

Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)

Treatment:

Other: Contingent singing

Tonal Vocal holding

Experimental group

Description:

Providing a 'blanket of tone' to comfort, engage or sedate

Treatment:

Other: Tonal Vocal holding

Muted shaker

Experimental group

Description:

If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate

Treatment:

Other: Muted shaker