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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
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.
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
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.
Tulane University Hospital
New Orleans, Louisiana, United States
RECRUITINGJoseph M. Sanzari Children's Hospital
Hackensack, New Jersey, United States
RECRUITINGNorthwell Health
New Hyde Park, New York, United States
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).
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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
Mount Sinai West
New York, New York, United States
RECRUITINGMaria Fareri Children's Hospital
Valhalla, New York, United States
RECRUITINGDrexel University/Hahnemann Hospital-College of Nursing and Health Professions
Philadelphia, Pennsylvania, United States
RECRUITINGTime frame: Baseline