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Music Therapy for Acute Respiratory Failure
N/A
Recruiting
Led By Joanne Loewy, DA, LCAT, MT-BC
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
Adult patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and ARDS admitted to the ICU requiring mechanical ventilation
Patients that are anticipated to remain on invasive mechanical ventilation for 48 hours or more will be screened for participation in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minute intervals over 30 minute intervention
Awards & highlights
Study Summary
This trial looks at the effects of music therapy on people who are on mechanical ventilation in an ICU.
Who is the study for?
This trial is for adult ICU patients with severe breathing problems who need a machine to help them breathe and are expected to need it for at least 48 hours. It's not for those under 18, with hearing issues, chronic breathing failure history, on multiple strong medications for blood pressure, in a coma, having seizures or cardiac arrest, deeply sedated (RASS score -4 or -5), or nearing end of life.Check my eligibility
What is being tested?
The study tests live music therapy tailored to each patient by certified therapists. The therapy includes toning and melodies aimed at syncing with the patient’s vital signs to see if it can reduce the time they spend on mechanical ventilation in the ICU.See study design
What are the potential side effects?
Since this is a non-drug treatment focusing on music therapy provided by professionals trained to adjust interventions according to patient response, significant side effects are not anticipated. However, individual reactions may vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult in the ICU needing a ventilator for severe lung issues.
Select...
I expect to be on a breathing machine for at least 48 hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 minute intervals over 30 minute intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minute intervals over 30 minute intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative Length of Time on Ventilator
Secondary outcome measures
Amount of sedation
Confusion Assessment Method for the ICU (CAM-ICU)
Cumulative Length of Stay in Hospital
+8 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: ToningExperimental Treatment1 Intervention
Vocal Tonal Holding
Group II: SOKExperimental Treatment1 Intervention
Song of kin with lyric content
Group III: ProcessExperimental Treatment1 Intervention
Processing of experience
Group IV: Ocean drum & SOK melodyExperimental Treatment1 Intervention
Ocean drum followed by melody of song of kin
Group V: Holding Harmonic ContainerExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,298 Total Patients Enrolled
John Mondanaro, MA, LCAT, MT-BC, CCLSStudy ChairIcahn School of Medicine at Mount Sinai
Joanne Loewy, DA, LCAT, MT-BCPrincipal Investigator - Icahn School of Medicine at Mount Sinai
Icahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
100 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The participant is in the final stage of life.I am an adult in the ICU needing a ventilator for severe lung issues.I have had a cardiac arrest.I am not in a coma.I have a diagnosed hearing disorder.I am currently experiencing seizures.I expect to be on a breathing machine for at least 48 hours.I am on more than two medications to raise my blood pressure.I am younger than 18 years old.I have needed a machine to help me breathe due to chronic lung problems.You have a RASS score of -4 or -5.
Research Study Groups:
This trial has the following groups:- Group 1: Toning
- Group 2: Ocean drum & SOK melody
- Group 3: SOK
- Group 4: Process
- Group 5: Holding Harmonic Container
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Are there still opportunities for volunteers to join this research endeavor?
"Affirmative. Data hosted on clinicaltrials.gov supports that this medical trial, first posted on December 12th 2018, is actively seeking enrolment. A total of 178 participants are required from a single location."
Answered by AI
How many participants have enrolled in this experimentation?
"Affirmative, the clinicaltrials.gov website avouches that this investigation has been recruiting since December 12th 2018 and was last reviewed on September 21st 2021. The study requires 178 participants to be enrolled across one site."
Answered by AI
Who else is applying?
What site did they apply to?
Mount Sinai West
What portion of applicants met pre-screening criteria?
Did not meet criteria
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