Music Therapy for Acute Respiratory Failure

Recruiting at2 trial locations

Overseen by Joanne Loewy, DA, LCAT, MT-BC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Hearing disorder, Seizures, Coma, others

No Placebo Group

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

Research Team

Joanne Loewy, DA, LCAT, MT-BC

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Holding Harmonic Container (Behavioral Intervention)
• Ocean drum & SOK melody (Behavioral Intervention)
• Process (Behavioral Intervention)
• SOK (Behavioral Intervention)
• Toning (Behavioral Intervention)

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.

Participant Groups

Group I: Toning Experimental Treatment 1 Intervention

Vocal Tonal Holding

Group II: SOK Experimental Treatment 1 Intervention

Song of kin with lyric content

Group III: Process Experimental Treatment 1 Intervention

Processing of experience

Group IV: Ocean drum & SOK melody Experimental Treatment 1 Intervention

Ocean drum followed by melody of song of kin

Group V: Holding Harmonic Container Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation. Bradt, J.[2019]

Music therapy is an effective complementary treatment for cancer patients, helping to improve mood, reduce stress, pain, and anxiety, and enhance relaxation during their treatment process.

Integrating music therapy into supportive cancer care can significantly promote overall wellness and improve both physical and emotional well-being, contributing to a better quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in supportive cancer care. Stanczyk, MM.[2022]

The paper provides a comprehensive overview of different methods used in music therapy, highlighting both their goals and limitations, which can help practitioners choose the most effective approach for their clients.

Two individual case studies are presented, illustrating the evolution and outcomes of music therapy, demonstrating its potential benefits in therapeutic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Music therapy, its indications, goals and possibilities]. Keller, V.[2008]

A case report on a premature infant born at 23 weeks of gestation suggests that active music therapy can positively influence motor and sensory development without causing stress, supporting the concept of 'minimal handling' in neonatal care.

The therapy led to observable improvements in the infant's motor responses and physiological parameters, such as increased oxygen levels and reduced heart rate, indicating potential benefits for the health and development of premature infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Music therapy for prematures]. Haus, R., Hennecke, KH.[2006]

Music therapy is an effective non-drug approach that can help reduce anxiety and promote relaxation in patients on mechanical ventilation, enhancing their overall care.

The article emphasizes the need for more research to better integrate music therapy into critical care nursing practices, aiming to create a more healing environment for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy as a nursing intervention for patients supported by mechanical ventilation. Chlan, LL.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Receptive Music Therapy for Patients Receiving Mechanical Ventilation in the Intensive Care Unit. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Multidisciplinary perspectives of music therapy in adult palliative care. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trials in Music Therapy: Guidelines for Design and Implementation. [2019]

4. Poland pubmed.ncbi.nlm.nih.gov

Music therapy in supportive cancer care. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Music therapy, its indications, goals and possibilities]. [2008]

6. Germany pubmed.ncbi.nlm.nih.gov

[Music therapy for prematures]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Music therapy as a nursing intervention for patients supported by mechanical ventilation. [2019]