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Purpose

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

Condition

Eligibility

Eligible Ages
Over 28 Weeks
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Counterbalancing will be achieved by assigning a different order of presentation of conditions for each group. Participants will remain in the study for two weeks, but continue to receive music therapy for the duration of their stay in the NICU.
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)
Masking Description
Parents of infants will be unaware of the interventions' effects. Outcomes Assessor will be unfamiliar with desired outcomes.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Song of Kin 		Voice (with or without guitar)- lullaby/ Holding meter
  • Behavioral: Song of Kin
    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
Experimental
Gato box 		Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate
  • Other: Gato box
    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
Experimental
Ocean disc 		Creating a consistent womb-like sound soundscape to comfort, engage or sedate
  • Other: Ocean disc
    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
Experimental
Contingent singing 		Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)
  • Other: Contingent singing
    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
Experimental
Tonal Vocal holding 		Providing a 'blanket of tone' to comfort, engage or sedate
  • Other: Tonal Vocal holding
    Music therapist will provide a vowel, long held tone, sung without vibrato
Experimental
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
  • Other: 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

Recruiting Locations

Tulane University Hospital
New Orleans, Louisiana 70112
Contact:
Meghan Howell, MD, FAAP
504-988-4158
mhowell2@tulane.edu

More Details

Status
Recruiting
Sponsor
Icahn School of Medicine at Mount Sinai

Study Contact

Joanne Loewy, DA, LCAT, MT-BC
212-420-3484
joanne.loewy@mountsinai.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.