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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 16-00740 | Other Identifier | Icahn School of Medicine at Mount Sinai |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Song of Kin | Experimental | Voice (with or without guitar)- lullaby/ Holding meter |
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| Gato box | Experimental | Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate |
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| Ocean disc | Experimental | Creating a consistent womb-like sound soundscape to comfort, engage or sedate |
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| Contingent singing | Experimental | Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position) |
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| Tonal Vocal holding | Experimental | Providing a 'blanket of tone' to comfort, engage or sedate |
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| Muted shaker | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Song of Kin | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | up to 2 weeks | |
| Respiratory Rate | up to 2 weeks | |
| O2 sats | Oxygen saturation levels (O2 sats) | 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 | 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. | 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) | 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) | up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanne Loewy, DA, LCAT, MT-BC | Contact | 212-420-3484 | joanne.loewy@mountsinai.org | |
| Elizabeth Barone, MA, MT-BC, CCLS | Contact | Elizabeth.Barone@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Joanne Loewy, PhD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Kathy Murphy, PhD | Loyola University | Principal Investigator |
| Aimee Telsey, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University Hospital | Recruiting | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23589814 | Background | Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15. | |
| 25773633 | Background | Loewy J. NICU music therapy: song of kin as critical lullaby in research and practice. Ann N Y Acad Sci. 2015 Mar;1337:178-85. doi: 10.1111/nyas.12648. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009357 | Neonatal Abstinence Syndrome |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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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.
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Parents of infants will be unaware of the interventions' effects. Outcomes Assessor will be unfamiliar with desired outcomes.
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
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| Gato box | Other | 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 |
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| Ocean disc | Other | 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. |
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| Contingent singing | Other | 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 |
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| Tonal Vocal holding | Other | Music therapist will provide a vowel, long held tone, sung without vibrato |
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| Muted shaker | Other | If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate |
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| Baseline |
| Icahn School of Medicine at Mount Sinai |
| Study Director |
| Joseph M. Sanzari Children's Hospital | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Northwell Health | Recruiting | New Hyde Park | New York | 11040 | United States |
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| Mount Sinai West | Recruiting | New York | New York | 10003 | United States |
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| Maria Fareri Children's Hospital | Recruiting | Valhalla | New York | 10595 | United States |
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| Drexel University/Hahnemann Hospital-College of Nursing and Health Professions | Recruiting | Philadelphia | Pennsylvania | 19102 | United States |
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| 27561729 | Background | Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25. |
| 33348423 | Derived | Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2. |
| D001523 | Mental Disorders |