Music Therapy for Delirium

(DyNamic Trial)

Overseen By Kara M Smith, MD MSCI FAAN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Must not be taking: Sedatives

Disqualifiers: Musicogenic seizures, Hearing loss, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new music therapy to help prevent delirium, a type of confusion, in hospital patients. It targets individuals with brain diseases such as Alzheimer's and Parkinson's. Participants will receive up to five personalized sessions, which may include live music, playing instruments, or listening to recordings. Ideal candidates are those staying at Boston Medical Center with cognitive impairments, who enjoy music, and are not heavily sedated. The trial aims to assess the feasibility and benefits of this therapy for future patients. As an unphased trial, participants contribute to innovative research that may enhance future care for individuals with cognitive impairments.

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. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this music therapy is safe for patients with brain diseases?

Past studies have shown that music therapy helps reduce the severity of delirium. Research indicates that music therapy is safe and well-tolerated by patients. For example, one study found that using music in the intensive care unit (ICU) significantly reduced delirium without causing harm. Another study suggested that early treatments like music therapy, which do not involve drugs, better ensure patient safety.

Overall, music therapy does not use drugs or involve invasive procedures, making it a low-risk option. Participants often find it calming and helpful. This makes it a safe choice for those interested in joining studies on music therapy for delirium. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about music therapy for delirium because it offers a non-drug approach that taps into the emotional and cognitive aspects of the brain. Unlike traditional treatments that primarily rely on medications like antipsychotics, music therapy uses personalized sessions involving re-creation, composition, improvisation, and therapeutic listening to engage patients in a meaningful way. This approach not only aims to reduce symptoms of delirium but also enhances patients' overall well-being by fostering a sense of connection and calmness without the side effects often associated with medications.

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

Research has shown that music therapy might help reduce symptoms of confusion, known as delirium. Some studies found that listening to slow music can significantly lower the risk of delirium in ICU patients. Other studies have shown fewer delirium episodes and better assessments of delirium after music therapy. This trial will focus on one-on-one music therapy sessions, customized to address patient needs. While not all studies show strong results, the overall trend is promising for using music therapy to help prevent confusion in patients with brain conditions, especially in hospitals. ^{2 3 6 7 8}

Who Is on the Research Team?

Kara M Smith, MD MSCI FAAN

Principal Investigator

Boston Medical Center, Neurology

Are You a Good Fit for This Trial?

This trial is for patients with brain diseases like Alzheimer's and Parkinson's who are hospitalized and at risk of delirium. The study aims to enroll around 30 participants who will undergo personalized music therapy sessions designed to prevent confusion during hospital stays.

Inclusion Criteria

I can join the study with a legal representative's consent if I'm unable to consent due to cognitive issues.

Admitted as inpatient to Boston Medical Center

I speak Spanish and will use a certified medical interpreter.

Exclusion Criteria

Pregnant women

Current prisoners

I am currently under observation in a hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo up to five music therapy sessions, each approximately 30 minutes, conducted by a board-certified music therapist.

1 week

Up to 5 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using delirium scores and other measures.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Music Therapy

Trial Overview The intervention being tested is a new type of music therapy tailored to each participant, which may involve live performances, playing instruments, or listening to recorded music. The goal is to assess the feasibility and perceived effectiveness in preventing delirium in neurodegenerative disease patients.

How Is the Trial Designed?

Group I: Music therapy Experimental Treatment 1 Intervention

Participants will undergo one-on-one music therapy (MT) sessions of approximately 30 minutes duration conducted by a board-certified music therapist. Sessions will be customized to address patient needs but will consistently adhere to the four principal MT methods of re-creation, composition, improvisation, and therapeutic listening experiences.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9138821/

Music Interventions and Delirium in Adults - PubMed Central Although not statistically significant, their results showed a trend towards improvement in delirium symptoms and suggested that researcher- ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nicc.13230

Dose–response analysis of music intervention for ... This study provides evidence that music intervention, especially slow-tempo music, significantly reduces the risk of delirium in ICU patients.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1064748125004919

'Pre-recorded Music Interventions on Delirium in ... Most included studies found both a reduction of delirium events, and more frequently negative delirium assessment outcomes following music ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03980782

NCT03980782 | The Effect of Music Therapy on Delirium Methods: A randomized control pilot study will be used to test the effect of a music therapist-developed, music listening intervention on delirium. Acutely ill ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2023/06160/the_effect_of_music_therapy_on_delirium_in.25.aspx

The effect of music therapy on delirium in patients... This study will provide evidence-based medical evidence for music therapy to control delirium in patients receiving mechanical ventilatory support in the ICU.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10270468/

The effect of music therapy on delirium in patients receiving ... Conclusion: This study will provide evidence-based medical evidence for music therapy to control delirium in patients receiving mechanical ventilatory support ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0964339722001513

The effect of music on delirium, pain, sedation and anxiety ... Significant decreases were found in the severity of delirium and pain and the level of sedation and anxiety in the music compared to the other groups (p < 0.05) ...

8. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06448-w

Decreasing delirium through music listening (DDM) in critically ... This randomized clinical trial will measure the efficacy of a music listening intervention for delirium and coma duration early in the intensive care unit ...