Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
Part of paid clinical trials in New Orleans, Louisiana.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT03533985
- Status
- Recruiting
Conditions
- NAS
Eligibility Criteria
- Sex
- ALL
- Age
- 28 Weeks - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Song of Kin — BEHAVIORALMusic 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.
- Gato box — OTHERDepending 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
- Ocean disc — OTHERDepending 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.
- Contingent singing — OTHERDepending on the state of the infant, the music therapist will provide short segments of conversant prosody, to enhance quiet-alert, or stimulate relaxation/sleep
- Tonal Vocal holding — OTHERMusic therapist will provide a vowel, long held tone, sung without vibrato
- Muted shaker — OTHERIf infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Study Details
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
Key Dates
- Start date
- Nov 1, 2017
- Status verified
- Feb 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Song of KinVoice (with or without guitar)- lullaby/ Holding meter
- Experimental: Gato boxSimple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate
- Experimental: Ocean discCreating a consistent womb-like sound soundscape to comfort, engage or sedate
- Experimental: Contingent singingProvision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)
- Experimental: Tonal Vocal holdingProviding a 'blanket of tone' to comfort, engage or sedate
- Experimental: Muted shakerIf infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Primary Outcome Measure
Heart Rate [ Time Frame: up to 2 weeks ]
Central Contacts
- Joanne Loewy, DA, LCAT, MT-BC212-420-3484
- Elizabeth Barone, MA, MT-BC, CCLS
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Tulane University Hospital | New Orleans | Louisiana | 70112 | Rachel Lee, MD Stacy Drury, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Joseph M. Sanzari Children's Hospital | Hackensack | New Jersey | 07601 | Ellen Goldring, MA (SUB_INVESTIGATOR) |
| Northwell Health | New Hyde Park | New York | 11040 | Shawna Vernisie, MA (SUB_INVESTIGATOR) |
| Mount Sinai West | New York | New York | 10003 | Jasmine Edwards, MA (SUB_INVESTIGATOR) |
| Maria Fareri Children's Hospital | Valhalla | New York | 10595 | Laurie Park, MA 914-493-7000 Laurie Park, MA (SUB_INVESTIGATOR) |
| Drexel University/Hahnemann Hospital-College of Nursing and Health Professions | Philadelphia | Pennsylvania | 19102 | Flossie Ierardi, MA (SUB_INVESTIGATOR) |
Find similar trials in New Orleans, LA
By research site
Tulane University Hospital· New Orleans, LAJoseph M. Sanzari Children's Hospital· Hackensack, NJNorthwell Health· New Hyde Park, NYMount Sinai West· New York, NYMaria Fareri Children's Hospital· Valhalla, NYDrexel University/Hahnemann Hospital-College of Nursing and Health Professions· Philadelphia, PA