An interventional study of Song of Kin and Gato box in NAS, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 6 sites in United States. Open to participants aged 28 Weeks and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
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.
Infants who meet the following inclusion criteria will be eligible to participate in the study irrespective of race, religion, ethnicity, or gender:
Exclusion Criteria:
Voice (with or without guitar)- lullaby/ Holding meter
Behavioral: Song of Kin
Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate
Other: Gato box
Creating a consistent womb-like sound soundscape to comfort, engage or sedate
Other: Ocean disc
Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)
Other: Contingent singing
Providing a 'blanket of tone' to comfort, engage or sedate
Other: Tonal Vocal holding
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Other: Muted shaker
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.
Also known as: Music psychotherapy with parent/s
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
Also known as: Rhythmic entrainment
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.
Also known as: Timbre entrainment
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
Music therapist will provide a vowel, long held tone, sung without vibrato
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Heart Rate
Time frame: up to 2 weeks
Respiratory Rate
Time frame: up to 2 weeks
O2 sats
Oxygen saturation levels (O2 sats)
Time frame: up to 2 weeks
Activity level
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
Time frame: up to 2 weeks
Sleep category
The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying.
Time frame: up to 2 weeks
Feeding (sucking and absorption) category
The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage)
Time frame: up to 2 weeks
Neonatal Abstinence Scoring (NAS)
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)
Time frame: up to 2 weeks
Postpartum Bonding Questionnaire (PBQ )
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).
Time frame: Baseline
Plan to share: No
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Icahn School of Medicine at Mount Sinai