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Music Therapy for Neonatal Abstinence Syndrome
N/A
Waitlist Available
Led By Kathy Murphy, PhD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No identified hearing disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 weeks
Awards & highlights
Study Summary
This trial looks at whether music therapy can help babies with Neonatal Abstinence Syndrome.
Who is the study for?
This trial is for infants with Neonatal Abstinence Syndrome who are at least 28 weeks gestational age, without hearing disorders or developmental disabilities like Down Syndrome. They must be admitted to the NICU right after birth and have a guardian able to consent and complete a questionnaire.Check my eligibility
What is being tested?
The study tests six music therapy interventions: Ocean disc, Contingent singing, Muted shaker, Song of Kin, Gato box, Tonal Vocal holding on newborns with Neonatal Abstinence Syndrome to see how they affect the babies' outcomes.See study design
What are the potential side effects?
Since this trial involves non-invasive music therapy interventions for infants, there are no direct side effects expected from the therapies themselves.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have a hearing disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Activity level
Feeding (sucking and absorption) category
Heart Rate
+4 moreSecondary outcome measures
Postpartum Bonding Questionnaire (PBQ )
Trial Design
6Treatment groups
Experimental Treatment
Group I: Tonal Vocal holdingExperimental Treatment1 Intervention
Providing a 'blanket of tone' to comfort, engage or sedate
Group II: Song of KinExperimental Treatment1 Intervention
Voice (with or without guitar)- lullaby/ Holding meter
Group III: Ocean discExperimental Treatment1 Intervention
Creating a consistent womb-like sound soundscape to comfort, engage or sedate
Group IV: Muted shakerExperimental Treatment1 Intervention
If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
Group V: Gato boxExperimental Treatment1 Intervention
Simple rhythms using Remo Gato box will be played by the MT-BC using a 3rd to comfort, engage or sedate
Group VI: Contingent singingExperimental Treatment1 Intervention
Provision of communicative vocalization-"parantese" to engage with infants, prosodic responses to infant cues (eye contact, body position)
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,086 Total Patients Enrolled
Kathy Murphy, PhDPrincipal InvestigatorLoyola University
Joanne Loewy, PhDPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this experiment still available?
"At this time, clinicaltrials.gov shows that this medical trial is not actively seeking participants; it was first listed on November 1st 2017 and its last edit occured January 19th 2022. However, there are 16 other studies presently recruiting patients."
Answered by AI
In what areas can people access this research?
"Six medical centres have been identified for this research, such as Drexel University/Hahnemann Hospital-College of Nursing and Health Professions in Philadelphia, Joseph M. Sanzari Children's Hospital in Hackensack, and Tulane University Hospital in New Orleans. Additionally there are 3 other recruitment sites."
Answered by AI
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