Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

Not Applicable

Recruiting

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

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
O2 sats	up to 2 weeks	Oxygen saturation levels (O2 sats)
Heart Rate	up to 2 weeks
Feeding (sucking and absorption) category	up to 2 weeks	The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage)
Neonatal Abstinence Scoring (NAS)	up to 2 weeks	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)
Respiratory Rate	up to 2 weeks
Sleep category	up to 2 weeks	The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying.
Activity level	up to 2 weeks	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

Secondary Outcome Measures

Name	Time	Method
Postpartum Bonding Questionnaire (PBQ )	Baseline	Questionnaire to assess capacity for attachment in both mothers and fathers. 25 item scale with each item rated from always to never. Scoring is based on four categories: impaired bonding scores 0-60, rejection and pathological anger scores 0-35, infant-focused anxiety scores 0-20, and incipient abuse scores 0-10. Total range from 0 (good bonding) to 125 (poor bonding).

Locations (6): Maria Fareri Children's Hospital
🇺🇸
Valhalla, New York, United States
Drexel University/Hahnemann Hospital-College of Nursing and Health Professions
🇺🇸
Philadelphia, Pennsylvania, United States
Mount Sinai West
🇺🇸
New York, New York, United States
Northwell Health
🇺🇸
New Hyde Park, New York, United States
Joseph M. Sanzari Children's Hospital
🇺🇸
Hackensack, New Jersey, United States
Tulane University Hospital
🇺🇸
New Orleans, Louisiana, United States