Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
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| ClinicalTrials.gov Identifier: NCT03533985 |
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Recruitment Status :
Recruiting
First Posted : May 23, 2018
Last Update Posted : October 20, 2020
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Sponsor:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Joanne Loewy, Icahn School of Medicine at Mount Sinai
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Brief Summary:
This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| NAS | Behavioral: Song of Kin Other: Gato box Other: Ocean disc Other: Contingent singing Other: Tonal Vocal holding Other: Muted shaker | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 200 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention 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: | Double (Participant, Outcomes Assessor) |
| Masking Description: | Parents of infants will be unaware of the interventions' effects. Outcomes Assessor will be unfamiliar with desired outcomes. |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study |
| Actual Study Start Date : | November 1, 2017 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Song of Kin
Voice (with or without guitar)- lullaby/ Holding meter
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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 Name: Music psychotherapy with parent/s |
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Experimental: Gato box
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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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 Name: Rhythmic entrainment |
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Experimental: Ocean disc
Creating a consistent womb-like sound soundscape to comfort, engage or sedate
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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 Name: Timbre entrainment |
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Experimental: Contingent singing
Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)
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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 |
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Experimental: Tonal Vocal holding
Providing a 'blanket of tone' to comfort, engage or sedate
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Other: Tonal Vocal holding
Music therapist will provide a vowel, long held tone, sung without vibrato |
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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
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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 |
Primary Outcome Measures :
- Heart Rate [ Time Frame: up to 2 weeks ]
- Respiratory Rate [ Time Frame: up to 2 weeks ]
- O2 sats [ Time Frame: up to 2 weeks ]Oxygen saturation levels (O2 sats)
- 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
- 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.
- 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)
- 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)
Secondary Outcome Measures :
- 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).
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| Ages Eligible for Study: | 28 Weeks and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533985
Contacts
| Contact: Joanne Loewy, DA, LCAT, MT-BC | 212-420-3484 | joanne.loewy@mountsinai.org | |
| Contact: Jasmine Edwards, MA, MT-BC | 212-420-2743 | Jasmine.Edwards1@mountsinai.org |
Locations
| United States, Louisiana | |
| Tulane University Hospital | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Meghan Howell, MD, FAAP 504-988-4158 mhowell2@tulane.edu | |
| Contact: Rachel Lee, MD rlee13@tulane.edu | |
| Principal Investigator: Stacy Drury, MD, PhD | |
| United States, New Jersey | |
| Joseph M. Sanzari Children's Hospital | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Naoko Mizutani, MA 551-996-2714 Naoko.Mizutani@hackensackmeridian.org | |
| Contact: Ellen Goldring 551-996-5146 Naoko.Mizutani@hackensackmeridian.org | |
| Sub-Investigator: Ellen Goldring, MA | |
| United States, New York | |
| Northwell Health | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Greg Razzano, MA 718-470-3000 grazzano@northwell.edu | |
| Contact: Shawna Vernisie, MA 718 470-3002 svernisie@northwell.edu | |
| Sub-Investigator: Shawna Vernisie, MA | |
| Mount Sinai West | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Ann Marie Dassler, NP 973-986-6306 amdassler@yahoo.com | |
| Contact: Aimee Telsey, MD 212 844-8387 amthome@gmail.com | |
| Sub-Investigator: Jasmine Edwards, MA | |
| Maria Fareri Children's Hospital | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Laurie Park, MA 914-493-7000 | |
| Contact: Lance Parton, MD (914) 493-6640 lanceaparton@yahoo.com | |
| Sub-Investigator: Laurie Park, MA | |
| United States, Pennsylvania | |
| Drexel University/Hahnemann Hospital-College of Nursing and Health Professions | Recruiting |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Contact: Flossie Ierardi, MA 267-359-5501 sah46@drexel.edu | |
| Contact: Scott Horwitz, MA (267) 359-5572 fmi22@drexel.edu | |
| Sub-Investigator: Flossie Ierardi, MA | |
Sponsors and Collaborators
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 |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Joanne Loewy, Director, Louis Armstrong Center for Music and Medicine at Mount Sinai Beth Israel, Icahn School of Medicine at Mount Sinai |
| ClinicalTrials.gov Identifier: | NCT03533985 |
| Other Study ID Numbers: |
GCO 16-1991 IRB 16-00740 ( Other Identifier: Icahn School of Medicine at Mount Sinai ) |
| First Posted: | May 23, 2018 Key Record Dates |
| Last Update Posted: | October 20, 2020 |
| Last Verified: | October 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Joanne Loewy, Icahn School of Medicine at Mount Sinai:
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Neonatal Abstinence Syndrome Music therapy Attachment Music medicine Multi-modal stimulation |
Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome Infant, Newborn, Diseases Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |