Music Therapy for Anxiety in Blood Cancer Procedures

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: City of Hope Medical Center

Must not be taking: Anxiolytics, Pain medications

Disqualifiers: Hearing impairments, Sedated procedures, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Single session

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if listening to music during a bone marrow biopsy or aspirate can reduce anxiety. It compares two groups: one listens to music during the procedure, and the other does not. Individuals who have had previous bone marrow biopsies or aspirates and are scheduled for another procedure might be suitable, provided they do not have hearing issues or require sedation. The goal is to assess whether music therapy (the clinical use of music interventions) can make these procedures less stressful for people with blood cancer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment validation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are scheduled to take any anxiety or pain medication 30 minutes before the procedure.

Is there any evidence suggesting that music therapy is likely to be safe for patients undergoing bone marrow biopsy/aspirate?

Research has shown that music therapy is a safe treatment option without harmful side effects. Studies indicate its safety because it involves no invasive procedures and is affordable. One study found that music therapy can lower anxiety and improve well-being in cancer patients. Reports have not documented negative effects from listening to music during medical procedures. Overall, music therapy is well-tolerated and can effectively reduce stress and anxiety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about music therapy for anxiety in blood cancer procedures because it offers a non-invasive way to potentially reduce anxiety without the side effects associated with medications. Unlike traditional anti-anxiety drugs, which can include sedatives or other pharmaceuticals, music therapy uses sound to help patients relax naturally. This approach could enhance patient comfort during stressful procedures like bone marrow biopsies, making it an attractive complement to standard care.

What evidence suggests that music therapy might be an effective treatment for anxiety?

Research has shown that music therapy can help reduce anxiety during medical procedures like bone marrow biopsies. In this trial, participants in one arm will listen to music while undergoing standard care bone marrow biopsy and/or aspiration. One study found that music lowered anxiety and pain in patients undergoing these procedures. Another review of 946 cancer patients found music therapy effective in reducing anxiety and distress. Early results also suggest that music therapy can cut anxiety symptoms by 50% after sessions. Overall, strong evidence indicates that listening to music during medical procedures can make patients feel calmer and more comfortable. ^{6 7 8 9 10}

Who Is on the Research Team?

Monzr M Al Malki

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with blood cancers needing a bone marrow biopsy or aspiration. Participants must understand English, give informed consent, and be willing to follow the study procedures without sedation or premedication for anxiety or pain.

Inclusion Criteria

Ability to read English, or willingness to have one of the staff members help with the questionnaire

I need a bone marrow test due to my blood condition.

Documented informed consent of the participant and/or legally authorized representative

Exclusion Criteria

I am scheduled for a sedated bone marrow biopsy.

I have hearing difficulties and use non-verbal ways to communicate.

I do not want to listen to music.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bone marrow biopsy and/or aspiration with or without music intervention

Single session

1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety and pain levels after the procedure

Up to 4 months

What Are the Treatments Tested in This Trial?

Interventions

• Music Therapy

Trial Overview

The study compares the usual bone marrow biopsy/aspiration procedure with and without passive music therapy to see if listening to music can reduce anxiety during the procedure.

How Is the Trial Designed?

Group I: Group II (listen to music) Experimental Treatment 4 Interventions

Patients listen to music while undergoing standard of care bone marrow biopsy and/or aspiration.

Group II: Group I (no music) Active Control 3 Interventions

Patients undergo standard of care bone marrow biopsy and/or aspiration.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A systematic review of 13 studies involving 946 cancer patients found that music therapy (MT) can be effective in reducing anxiety and distress associated with radiation treatment (RT).

The review highlights the potential of MT as a supportive intervention for oncology patients, suggesting it may improve their emotional well-being before and during RT, although further research is needed to address clinical management challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy and radiation oncology: State of art and future directions. Nardone, V., Vinciguerra, C., Correale, P., et al.[2020]

In a study involving 259 pediatric patients in the intensive care unit, live music therapy significantly reduced heart rates, breathing rates, and levels of discomfort during the sessions.

The findings suggest that music therapy could be an effective nonpharmacological intervention to help manage pain and anxiety in critically ill children, despite its limited current use in PICUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a live music therapy intervention on critically ill paediatric patients in the intensive care unit: A quasi-experimental pretest-posttest study. Mata Ferro, M., Falcó Pegueroles, A., Fernández Lorenzo, R., et al.[2023]

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]

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, which has been used since ancient times and incorporated into modern medicine since the 1950s, is now a common practice in cancer care, particularly in large cancer centers in the U.S.

When combined with conventional cancer treatments, music therapy has been shown to improve patients' quality of life, enhance emotional expression, reduce stress, and alleviate physical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in a comprehensive cancer center. Richardson, MM., Babiak-Vazquez, AE., Frenkel, MA.[2008]

Music therapy can significantly enhance the hospital experience for patients, suggesting it may have beneficial effects on their overall well-being during treatment.

The review synthesizes current research, indicating that incorporating music therapy into hospital care could lead to improved patient satisfaction and emotional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of music therapy on patients' perception and manifestation of pain, anxiety, and patient satisfaction. Richards, T., Johnson, J., Sparks, A., et al.[2015]

Music therapy can significantly help pediatric oncology patients by addressing physical, social, and psychological needs, such as reducing pain and anxiety, and decreasing reliance on pain medication.

It promotes social interaction and emotional expression, enhancing relationships with healthcare providers and family, which is crucial for patients undergoing long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy research and applications in pediatric oncology treatment. Standley, JM., Hanser, SB.[2017]

Music therapy, led by credentialed therapists, is an effective complementary treatment in oncology that helps reduce stress, anxiety, pain, and nausea in patients.

The therapy is tailored to individual patient needs and can involve active or passive participation, ensuring safety and promoting positive clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy: a valuable adjunct in the oncology setting. Mahon, EM., Mahon, SM.[2011]

A review of 12 clinical studies involving 922 cancer patients indicates that music therapy can lead to short-term improvements in mood, relaxation, and reductions in anxiety and pain, particularly in pediatric oncology settings.

Case vignettes illustrate that music therapy can help patients express emotions and shift focus from their illness to a healthier mindset, suggesting its potential as a supportive treatment in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Music Therapy During the Treatment of Cancer Patients: A Collection of Evidence. Boyde, C., Linden, U., Boehm, K., et al.[2020]

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