search
Back to results

Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

Primary Purpose

NAS

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Song of Kin
Gato box
Ocean disc
Contingent singing
Tonal Vocal holding
Muted shaker
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NAS focused on measuring Neonatal Abstinence Syndrome, Music therapy, Attachment, Music medicine, Multi-modal stimulation

Eligibility Criteria

28 Weeks - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tulane University Hospital
  • Joseph M. Sanzari Children's Hospital
  • Northwell Health
  • Mount Sinai West
  • Maria Fareri Children's Hospital
  • Drexel University/Hahnemann Hospital-College of Nursing and Health Professions

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Song of Kin

Gato box

Ocean disc

Contingent singing

Tonal Vocal holding

Muted shaker

Arm Description

Voice (with or without guitar)- lullaby/ Holding meter

Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate

Creating a consistent womb-like sound soundscape to comfort, engage or sedate

Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)

Providing a 'blanket of tone' to comfort, engage or sedate

If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate

Outcomes

Primary Outcome Measures

Heart Rate
Respiratory Rate
O2 sats
Oxygen saturation levels (O2 sats)
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
Sleep category
The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying.
Feeding (sucking and absorption) category
The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage)
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)

Secondary Outcome Measures

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).

Full Information

First Posted
May 11, 2018
Last Updated
April 14, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
search

1. Study Identification

Unique Protocol Identification Number
NCT03533985
Brief Title
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
Official Title
The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAS
Keywords
Neonatal Abstinence Syndrome, Music therapy, Attachment, Music medicine, Multi-modal stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Parents of infants will be unaware of the interventions' effects. Outcomes Assessor will be unfamiliar with desired outcomes.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Song of Kin
Arm Type
Experimental
Arm Description
Voice (with or without guitar)- lullaby/ Holding meter
Arm Title
Gato box
Arm Type
Experimental
Arm Description
Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate
Arm Title
Ocean disc
Arm Type
Experimental
Arm Description
Creating a consistent womb-like sound soundscape to comfort, engage or sedate
Arm Title
Contingent singing
Arm Type
Experimental
Arm Description
Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)
Arm Title
Tonal Vocal holding
Arm Type
Experimental
Arm Description
Providing a 'blanket of tone' to comfort, engage or sedate
Arm Title
Muted shaker
Arm Type
Experimental
Arm Description
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Intervention Type
Behavioral
Intervention Name(s)
Song of Kin
Other Intervention Name(s)
Music psychotherapy with parent/s
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Gato box
Other Intervention Name(s)
Rhythmic entrainment
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Ocean disc
Other Intervention Name(s)
Timbre entrainment
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Contingent singing
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Tonal Vocal holding
Intervention Description
Music therapist will provide a vowel, long held tone, sung without vibrato
Intervention Type
Other
Intervention Name(s)
Muted shaker
Intervention Description
If 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 Information:
Title
Heart Rate
Time Frame
up to 2 weeks
Title
Respiratory Rate
Time Frame
up to 2 weeks
Title
O2 sats
Description
Oxygen saturation levels (O2 sats)
Time Frame
up to 2 weeks
Title
Activity level
Description
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
Time Frame
up to 2 weeks
Title
Sleep category
Description
The neonatologist or nurse will assess and mark as quiet sleep, active sleep, drowsy state, alert inactivity, fussing or crying.
Time Frame
up to 2 weeks
Title
Feeding (sucking and absorption) category
Description
The neonatologist or nurse will rate feeding (sucking/absorption) from 1 (active/perpetual) to 12 (none/gavage)
Time Frame
up to 2 weeks
Title
Neonatal Abstinence Scoring (NAS)
Description
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)
Time Frame
up to 2 weeks
Secondary Outcome Measure Information:
Title
Postpartum Bonding Questionnaire (PBQ )
Description
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).
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Loewy, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathy Murphy, PhD
Organizational Affiliation
Loyola University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aimee Telsey, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Study Director
Facility Information:
Facility Name
Tulane University Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Joseph M. Sanzari Children's Hospital
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Northwell Health
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Maria Fareri Children's Hospital
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Drexel University/Hahnemann Hospital-College of Nursing and Health Professions
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23589814
Citation
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.
Results Reference
background
PubMed Identifier
25773633
Citation
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.
Results Reference
background
PubMed Identifier
27561729
Citation
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.
Results Reference
background
PubMed Identifier
33348423
Citation
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.
Results Reference
derived
Links:
URL
http://nicumusictherapy.com
Description
Related Info
URL
http://musicandmedicine.org
Description
Related Info

Learn more about this trial

Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome

We'll reach out to this number within 24 hrs