Music for Heart Failure

(MUSIC-CPX Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Maya T Ignaszewski, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Peggy J Hardesty

Disqualifiers: Severe hearing deficiency, unable to exercise

No Placebo Group

Trial Summary

What is the purpose of this trial?

The study aims to assess the effect of music on the heart resulting in a change in their exercise capacity among systolic heart failure patients undergoing Cardiopulmonary Exercise testing.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Music, Music Therapy, Auditory Stimulation for heart failure?

Listening to classical music may improve quality of life, sleep quality, and reduce anxiety and depression in heart failure patients, although it does not directly improve survival or reduce hospitalizations. Additionally, nature sounds, similar to music therapy, have been shown to reduce fatigue in heart failure patients. ^{1 2 3 4 5}

Is listening to music safe for people with heart failure or other medical conditions?

Listening to music is generally considered safe for people with heart failure and other medical conditions. Studies have shown that music can improve quality of life, reduce anxiety and depression, and have positive effects on well-being without causing harm. ^{2 3 6 7 8}

How does music therapy differ from other treatments for heart failure?

Music therapy for heart failure is unique because it uses listening to music to positively influence heart health through pathways involving the mind, immune system, and hormones, rather than relying on drugs or surgery. This approach aims to improve quality of life, sleep, and emotional well-being, offering a non-invasive and holistic complement to traditional treatments. ^{2 3 7 9 10}

Research Team

Maya T Ignaszewski, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for English-speaking adults over 18 with systolic heart failure who can consent to participate. It's not suitable for those with severe hearing issues or an inability to exercise.

Inclusion Criteria

I am over 18 years old.

Able to consent

English speaking

Exclusion Criteria

You cannot do physical activity.

I have a severe hearing problem.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Cardiopulmonary Exercise (CPX) testing with or without music

15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Music (Behavioural Intervention)

Trial Overview The study is testing the impact of music on exercise capacity in heart failure patients during Cardiopulmonary Exercise tests, aiming to see if it improves their heart function and ability to exercise.

Participant Groups

Group I: Music Experimental Treatment 1 Intervention

Music arm will listen to pre-selected music during their duration of the exercise testing via headphones that will be provided to the patients by the study personnel.

Group II: Non-music Active Control 1 Intervention

Non-music arm will not have pre-selected music playing during their duration of the exercise testing via the headphones provided to the patients by the study personnel.

Who Is Running the Clinical Trial?

Peggy J Hardesty

Lead Sponsor

Trials

1

Recruited

40+

Maya Ignaszewski

Lead Sponsor

Trials

1

Recruited

40+

Gaurang Vaidya

Lead Sponsor

Trials

2

Recruited

220+

Findings from Research

This study is a multicenter randomized controlled trial involving 150 heart failure patients, aiming to assess the effectiveness of a specific recorded music-listening protocol on improving quality of life and reducing symptom burden over a 3-month period.

If successful, the findings could establish recorded music listening as a beneficial intervention for heart failure patients, potentially enhancing their overall well-being alongside standard medical care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Listening to Recorded Music for Heart Failure Patients: Study Protocol. Burrai, F., Hasan, W., Fancourt, D., et al.[2016]

In a multicenter randomized controlled trial involving 159 heart failure patients, listening to recorded classical music for at least 30 minutes a day over 3 months significantly improved heart failure-specific quality of life, generic quality of life, sleep quality, and reduced anxiety and depression levels.

This noninvasive and safe intervention demonstrates that classical music can be an effective complementary treatment to enhance the overall well-being of heart failure patients in a home-care setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial Effects of Listening to Classical Music in Patients With Heart Failure: A Randomized Controlled Trial. Burrai, F., Sanna, GD., Moccia, E., et al.[2021]

Music listening protocols may offer a novel approach to improving cardiovascular health in patients with heart failure, potentially enhancing their overall treatment alongside traditional methods.

The proposed framework suggests that music can positively influence heart health through complex interactions involving psychological, neurological, immune, and endocrine systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Conceptual Framework Encompassing the Psychoneuroimmunoendocrinological Influences of Listening to Music in Patients With Heart Failure. Burrai, F., Hasan, W., Luppi, M., et al.[2018]

In a study involving 105 hospitalized heart failure patients, both Benson muscle relaxation and nature sounds significantly reduced fatigue compared to a control group, highlighting their potential as effective interventions.

There was no significant difference in fatigue reduction between the two methods, suggesting that both are viable, low-cost alternatives that can be easily integrated into routine nursing care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Effects of Benson Muscle Relaxation and Nature Sounds on the Fatigue in Patients With Heart Failure: A Randomized Controlled Clinical Trial. Seifi, L., Najafi Ghezeljeh, T., Haghani, H.[2018]

Drug therapy for heart failure can significantly improve symptoms and quality of life, especially in patients with severe heart failure, while also aiming to reduce the risk of serious events like ventricular arrhythmias and extend survival.

The effectiveness of heart failure treatments varies by the stage of the disease; early treatment may lead to better survival rates, while advanced stages focus more on symptom relief and quality of life rather than survival extension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic targets and expectations for the treatment of heart failure. Taylor, SH.[2019]

A meta-analysis of 183 studies across 11 medical specialties found that music therapy interventions have significantly greater positive effects on outcomes like pain, well-being, mood, and nausea/vomiting compared to music medicine interventions.

The analysis particularly highlighted benefits for patients with cancer, those who are terminally ill, and patients with HIV, indicating that music therapy can be an effective complementary treatment in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music and music therapy on medical patients: a meta-analysis of the research and implications for the future. Dileo, C.[2022]

A review of 29 studies involving 2579 patients found that receptive music intervention did not lead to significant changes in cardiovascular measures like heart rate and blood pressure, particularly in higher quality studies with 1054 patients.

Due to the high variability in study methods and quality, no definitive conclusions can be drawn about the effectiveness of music as a therapeutic intervention for cardiovascular health, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of music on patients with cardiovascular diseases and during cardiovascular interventions : A systematic review. Ho, CY., Wexberg, P., Schneider, B., et al.[2021]

Music therapy has been effectively used in cardiac care for patients with conditions like acute myocardial infarction and coronary artery bypass graft, helping them cope with stress during recovery.

The article reviews research and provides case examples, demonstrating various clinical methods that music therapists use to support patients' emotional and psychological well-being in cardiac settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of music therapy in cardiac healthcare. Hanser, SB., Mandel, SE.[2008]

Music therapy is safe and effective for reducing stress in patients in coronary care units, helping to manage their psychophysiological stress responses.

Age and gender may affect how the autonomic nervous system responds to cardiovascular stress, indicating that older adults should learn techniques to manage blood pressure changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variables influencing cardiovascular function. Fitzsimmons, L., Shively, M., Verderber, A.[2019]

References

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

A Randomized Controlled Trial of Listening to Recorded Music for Heart Failure Patients: Study Protocol. [2016]

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

Beneficial Effects of Listening to Classical Music in Patients With Heart Failure: A Randomized Controlled Trial. [2021]

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

A Conceptual Framework Encompassing the Psychoneuroimmunoendocrinological Influences of Listening to Music in Patients With Heart Failure. [2018]

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

Comparison of the Effects of Benson Muscle Relaxation and Nature Sounds on the Fatigue in Patients With Heart Failure: A Randomized Controlled Clinical Trial. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Therapeutic targets and expectations for the treatment of heart failure. [2019]

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

Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

Effects of music and music therapy on medical patients: a meta-analysis of the research and implications for the future. [2022]

8. Austria pubmed.ncbi.nlm.nih.gov

Effect of music on patients with cardiovascular diseases and during cardiovascular interventions : A systematic review. [2021]

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

The effects of music therapy in cardiac healthcare. [2008]

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

Variables influencing cardiovascular function. [2019]