Music Therapy for Anxiety in Blood Cancer Procedures

Overseen by Monzr M Al Malki

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: City of Hope Medical Center

Must not be taking: Anxiolytics, Pain medications

Disqualifiers: Hearing impairments, Sedated procedures, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This phase III trial compares the effect of adding passive music when undergoing bone marrow biopsy/aspirate versus bone marrow biopsy/aspirate alone in reducing anxiety. Music therapy helps relieve pain or stress and promote well-being. Listening to music during a bone marrow biopsy/aspirate procedure may reduce anxiety during the procedure.

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.

What data supports the effectiveness of the treatment Music Therapy for Anxiety in Blood Cancer Procedures?

Research shows that music therapy can improve mood, reduce stress and anxiety, and enhance relaxation for cancer patients. It is used in hospitals to help manage pain and improve the overall quality of life during treatment. ^{1 2 3 4 5}

Is music therapy safe for use in humans, particularly in cancer care?

Music therapy is generally considered safe for humans and is used to support cancer care by improving mood, reducing stress, pain, and anxiety, and enhancing relaxation. It is a non-drug approach that can be integrated into medical treatment to promote physical and emotional well-being. ^{1 4 6 7 8}

How does music therapy differ from other treatments for anxiety in blood cancer procedures?

Music therapy is unique because it uses music to help reduce anxiety, stress, and pain, and improve mood and relaxation during cancer treatments. Unlike medications, it involves interactive techniques like singing or listening to music, and is part of a complementary approach to support emotional and physical well-being. ^{1 4 5 7 9}

Research Team

Monzr M Al Malki

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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 will be given medication for anxiety or pain 30 minutes before my procedure.

Trial Timeline

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

Treatment Details

Interventions

• Music Therapy (Behavioural Intervention)

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.

Participant Groups

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+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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 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]

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 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, 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]

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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Music therapy in supportive cancer care. [2022]

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

The effect of music therapy on patients' perception and manifestation of pain, anxiety, and patient satisfaction. [2015]

3. 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]

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

Music therapy research and applications in pediatric oncology treatment. [2017]

5. Canada pubmed.ncbi.nlm.nih.gov

Music therapy in a comprehensive cancer center. [2008]

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

The Use of Music Therapy During the Treatment of Cancer Patients: A Collection of Evidence. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Music therapy and radiation oncology: State of art and future directions. [2020]

8. Australia 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. [2023]

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

Music therapy: a valuable adjunct in the oncology setting. [2011]