178 Participants Needed

Music Therapy for Acute Respiratory Failure

Recruiting at 2 trial locations
JL
GB
CP
Overseen ByChristopher Pizzute, MA, LCAT-LP, MT-BC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Icahn School of Medicine at Mount Sinai
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

While most studies in the medical literature that indicate "music" as an intervention may recognize its impact and capacity to decrease pain perception, anxiety, and/or its role in the regulation of cardiac and respiratory function in ICU patients, no identifiable studies have implemented entrained live music therapy protocols into clinical trials. Music therapy treatment is a non-pharmacological intervention that is individually tailored to the patient's needs and focuses on the assessment and intervention of a specific music application that is provided by a certified music therapist. Entrained music therapy focuses on a dynamic interaction between the patient and music therapist in which the music therapist attempts to promote relaxation and comfort through the patient's identified Song of Kin (SOK). This study measures the effects of live music therapy entrained to the vital signs of adult patients on duration of mechanical ventilation.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

How is the music therapy treatment for acute respiratory failure different from other treatments?

This music therapy treatment is unique because it uses live music and specific instruments like the Ocean drum and Song of Kin melody to help reduce anxiety and improve relaxation in patients with acute respiratory failure. Unlike traditional drug treatments, it focuses on creating a calming environment through sound, which can be particularly beneficial for patients on mechanical ventilation.12345

What data supports the effectiveness of the treatment Music Therapy for Acute Respiratory Failure?

Research shows that live music therapy can reduce anxiety, decrease pain, and improve the physiological response of patients in the intensive care unit (ICU), which suggests it may help those with acute respiratory failure as well.34567

Who Is on the Research Team?

JL

Joanne Loewy, DA, LCAT, MT-BC

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am an adult in the ICU needing a ventilator for severe lung issues.
I expect to be on a breathing machine for at least 48 hours.

Exclusion Criteria

The participant is in the final stage of life.
I have had a cardiac arrest.
I am not in a coma.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive live music therapy tailored to their cultural preferences and vital signs, provided by a certified music therapist

14 days
Daily sessions in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measures of anxiety, delirium, and pain

14 days

What Are the Treatments Tested in This Trial?

Interventions

  • Holding Harmonic Container
  • Ocean drum & SOK melody
  • Process
  • SOK
  • Toning
Trial Overview 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.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: ToningExperimental Treatment1 Intervention
Group II: SOKExperimental Treatment1 Intervention
Group III: ProcessExperimental Treatment1 Intervention
Group IV: Ocean drum & SOK melodyExperimental Treatment1 Intervention
Group V: Holding Harmonic ContainerExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Published Research Related to This Trial

In a study of 118 adult ICU patients on mechanical ventilation, live music therapy significantly reduced agitation and heart rate compared to standard care, indicating its efficacy in managing anxiety and physiological responses.
Patients receiving live music therapy showed improved scores on agitation and pain scales, suggesting that music therapy can be a beneficial intervention for intubated patients in critical care settings.
Receptive Music Therapy for Patients Receiving Mechanical Ventilation in the Intensive Care Unit.Golino, AJ., Leone, R., Gollenberg, A., et al.[2023]
Music therapy is recognized as a valuable therapeutic intervention in palliative care, providing emotional, physical, social, and spiritual benefits to patients, as reported by 20 multidisciplinary colleagues in five UK hospices.
There is a need for greater understanding of the music therapist's role, particularly among nursing staff, which could be improved through collaborative efforts and educational workshops to enhance integration within palliative care teams.
Multidisciplinary perspectives of music therapy in adult palliative care.O'Kelly, J., Koffman, J.[2016]
Randomized controlled trials (RCTs) can significantly contribute to the evidence base for music therapy, and it is crucial for music therapists to design studies that meet current methodological standards.
The article provides practical guidelines for implementing RCT design in music therapy, addressing challenges such as randomization, blinding, and outcome selection, which can help accurately estimate the benefits of music therapy treatments.
Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation.Bradt, J.[2019]

Citations

Receptive Music Therapy for Patients Receiving Mechanical Ventilation in the Intensive Care Unit. [2023]
Multidisciplinary perspectives of music therapy in adult palliative care. [2016]
Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation. [2019]
Music therapy in supportive cancer care. [2022]
[Music therapy, its indications, goals and possibilities]. [2008]
[Music therapy for prematures]. [2006]
Music therapy as a nursing intervention for patients supported by mechanical ventilation. [2019]
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