NCT Number: NCT03533985
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
Interested in participating?
Request Info28 week and older
All sexes
Interventional
Not applicable
Tulane University Hospital, New Orleans, Louisiana, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Infants who meet the following inclusion criteria will be eligible to participate in the study irrespective of race, religion, ethnicity, or gender:
Exclusion criteria
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.
Other names: 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
Other names: 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.
Other names: 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
Time frame: up to 2 weeks
Time frame: up to 2 weeks
Time frame: up to 2 weeks
Oxygen saturation levels (O2 sats)
Time frame: 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
Time frame: up to 2 weeks
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
The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage)
Time frame: 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)
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Elizabeth Barone, MA, MT-BC, CCLS
CONTACT
Joanne Loewy, DA, LCAT, MT-BC
CONTACT
Icahn School of Medicine at Mount Sinai
Other
The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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