Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

NCT03533985 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-02-24

No results posted yet for this study

Summary

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

Conditions

  • NAS

Interventions

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

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

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

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

OTHER

Tonal Vocal holding

Music therapist will provide a vowel, long held tone, sung without vibrato

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

Sponsors & Collaborators

Principal Investigators

  • Joanne Loewy, PhD · Icahn School of Medicine at Mount Sinai

  • Kathy Murphy, PhD · Loyola University

  • Aimee Telsey, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533985 on ClinicalTrials.gov