Music Therapy for Acute Respiratory Failure

Recruiting at 2 trial locations

Overseen By Christopher Pizzute, MA, LCAT-LP, MT-BC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Hearing disorder, Seizures, Coma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 14 days

178 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether music therapy can aid individuals with acute respiratory failure. The goal is to determine if live music, tailored to each patient's needs, can reduce the duration of mechanical ventilation (a machine that assists with breathing). The trial will test various music therapy types, including Holding Harmonic Container, Ocean Drum & SOK Melody, and vocal techniques. Adults on mechanical ventilation in the ICU for at least 48 hours due to severe breathing issues may qualify to participate. As an unphased trial, this study provides a unique opportunity to explore innovative therapies that could enhance recovery and improve quality of life.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that music therapy is safe and effective for treating conditions like breathing problems. For the "Toning" treatment, studies indicate that music therapy is generally well-tolerated, with no major side effects reported. This suggests it is safe for individuals with conditions like COPD and respiratory failure.

The "Ocean drum & SOK melody" approach has also been researched, and findings show that music therapy can improve mental well-being without causing harm. It is often used to reduce anxiety and discomfort in patients who require machines to assist with breathing.

Regarding the "SOK" (Song of Kin), studies have found that live music therapy can be helpful and safe for patients, easing breathing difficulties. This method involves a music therapist using music that is personally meaningful to the patient, enhancing the therapy's effect without compromising safety.

The "Process" and "Holding Harmonic Container" treatments have not shown any harmful effects in studies. These methods use music to create a calming environment, helping patients feel more relaxed and comfortable.

Overall, these music therapy treatments are considered safe. They aim to promote relaxation and reduce anxiety without the risks associated with medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Music Therapy for Acute Respiratory Failure trial because it explores innovative, non-drug approaches to help patients breathe better. Unlike standard treatments like mechanical ventilation and pharmacological interventions, this trial investigates how sound and music can support respiratory function. The unique treatments include "Toning," which uses vocal sounds to create a calming effect, and "Ocean drum & SOK melody," which combines soothing drum sounds with personalized music from loved ones. These methods aim to enhance emotional well-being and potentially improve physiological outcomes, offering a holistic complement to traditional therapies.

What evidence suggests that this trial's music therapy treatments could be effective for acute respiratory failure?

Research has shown that live music therapy, similar to the methods used in this trial, can calm ICU patients on breathing machines and lower their heart rates. One study with 118 adult ICU patients found that music therapy led to significant improvements compared to regular care. In this trial, participants may receive the Ocean drum and Song of Kin (SOK) techniques, designed to help patients relax and feel more comfortable, potentially improving their breathing. Other participants may experience the Toning and Process methods, which focus on using the voice and expressing emotions, possibly reducing anxiety and improving breathing. Overall, these music therapy techniques are believed to help patients relax, potentially leading to shorter times on breathing machines. ^{1 6 7 8 9}

Who Is on the Research Team?

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.

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?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1.

withpower.com

withpower.com/trial/phase-respiratory-distress-syndrome-newborn-11-2018-9f215

Music Therapy for Acute Respiratory Failure

In a study of 118 adult ICU patients on mechanical ventilation, live music therapy significantly reduced agitation and heart rate compared to standard care, ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11813770/

Effectiveness of a harmonica-integrated, tele-supervised ...

The HADS is widely validated in Chinese COPD clinical settings as a reliable measure of psychological distress (30). 2.9.2.8 Self-efficacy. Self ...

3.

clinicaltrial.be

clinicaltrial.be/en/details/67537?per_page=100&only_recruiting=1&only_eligible=0&only_active=0

The Effects of Music Therapy on Adult Patients Requiring...

Inclusion Criteria: Adult patients with acute hypoxemic respiratory failure, acute hypercapnic respiratory failure, and ARDS admitted to the ICU ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12229233/

The Effectiveness of Structured Neurologic Music Therapy on ...

Objective. To analyze the effectiveness of neurologic music therapy (NMT), consisting of diaphragmatic breathing (DB), vocal intonation ...

5.

researchgate.net

researchgate.net/publication/346636126_Music_Therapy_in_Adults_With_COPD

Music Therapy in Adults With COPD

100 There are no doubts as to the effectiveness of oxygen therapy in the treatment of acute and respiratory failure in different clinical ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10957573/

Efficacy and safety of a music-therapy facilitated pulmonary ...

Efficacy and safety of a music-therapy facilitated pulmonary telerehabilitation program in COPD patients: the COPDMELODY study protocol

7.

ctv.veeva.com

ctv.veeva.com/study/the-effects-of-music-therapy-on-adult-patients-requiring-mechanical-ventilation-in-the-icu

The Effects of Music Therapy on Adult Patients Requiring ...

The Effects of Music Therapy on Adult Patients Requiring Mechanical Ventilation in the ICU · Other: SOK · Other: Toning · Other: Holding Harmonic ...

8.

mdpi.com

mdpi.com/2673-8112/5/7/107

The Feasibility of a Music Therapy Respiratory Telehealth ...

This study aims to investigate the feasibility of an online music therapy protocol for individuals previously diagnosed with COVID-19.

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/12231488/

High-frequency oscillatory ventilation for acute respiratory ...

We conclude that high-frequency oscillation is a safe and effective mode of ventilation for the treatment of acute respiratory distress syndrome in adults.