Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

April 14, 2023 updated by: Joanne Loewy, Icahn School of Medicine at Mount Sinai

The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Hospital
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Joseph M. Sanzari Children's Hospital
    • New York
      • New Hyde Park, New York, United States, 11040
        • Northwell Health
      • New York, New York, United States, 10003
        • Mount Sinai West
      • Valhalla, New York, United States, 10595
        • Maria Fareri Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University/Hahnemann Hospital-College of Nursing and Health Professions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: up to 2 weeks
up to 2 weeks
Respiratory Rate
Time Frame: up to 2 weeks
up to 2 weeks
O2 sats
Time Frame: up to 2 weeks
Oxygen saturation levels (O2 sats)
up to 2 weeks
Activity level
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
up to 2 weeks
Sleep category
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.
up to 2 weeks
Feeding (sucking and absorption) category
Time Frame: up to 2 weeks
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)
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)
up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postpartum Bonding Questionnaire (PBQ )
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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Joanne Loewy, PhD, Icahn School of Medicine at Mount Sinai
  • Principal Investigator: Kathy Murphy, PhD, Loyola University
  • Study Director: Aimee Telsey, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

May 11, 2018

First Posted (Actual)

May 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 16-1991
  • IRB 16-00740 (Other Identifier: Icahn School of Medicine at Mount Sinai)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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