Music Therapy for ICU Delirium

(DDM Trial)

No longer recruiting at 4 trial locations

Overseen By Lori Rawlings, BSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Dementia, Psychiatric illness, Alcohol withdrawal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if listening to slow-tempo music can reduce delirium (a state of confusion) in older adults who are critically ill and on ventilators in the ICU. Participants will either listen to relaxing music or sit in silence for an hour, twice a day, over a week. The trial seeks to discover if music can increase the number of days patients remain free from delirium or coma. Suitable candidates are English-speaking individuals aged 50 or older, who are in the ICU, expected to need a ventilator for at least 48 hours, and have someone who can provide consent on their behalf. As an unphased trial, this study offers a unique opportunity to explore innovative non-drug therapies that could enhance patient well-being.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this music therapy is safe for ICU patients?

Research shows that slow-tempo music is safe for patients in intensive care. Studies have found that listening to music with a slow beat (60-80 beats per minute) can lower the risk of confusion in ICU patients. Patients tolerate this type of music well and experience fewer days of confusion or coma when they listen to it regularly.

A review of studies also found that slow-tempo music can reduce pain and improve sleep. Importantly, these studies report no negative effects from this music therapy. Therefore, for those considering joining a trial involving slow-tempo music, current research supports it as a safe and potentially helpful treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for ICU delirium that often rely on medications to manage symptoms, slow tempo music offers a non-invasive alternative that aims to soothe and calm patients through auditory stimulation. This approach uses relaxing music at 60-80 beats per minute, delivered through noise-canceling headphones, which could potentially reduce stress and confusion without the side effects associated with drugs. Researchers are excited about this treatment because it harnesses the natural power of music to influence mood and cognitive function, offering a novel way to improve patient outcomes in a critical care environment.

What evidence suggests that slow tempo music might be an effective treatment for ICU delirium?

Research has shown that slow-tempo music, which participants in this trial may receive, can help reduce confusion and disorientation in very sick patients. Studies have found that listening to music can lower anxiety, stress, and the need for strong sedatives. Reducing these factors might mean patients spend less time in a confused state or coma. In some cases, music therapy has also been linked to shorter times on breathing machines for patients in intensive care. While more research is needed, these findings suggest that music could be a useful tool for those at risk of confusion in the ICU. Another group in this trial will receive attention control, consisting of silence sessions, to compare the effects. ^{2 3 6 7 8}

Who Is on the Research Team?

Linda Chlan, PhD, RN

Principal Investigator

Mayo Clinic

Babar Khan, MD, MS

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for critically ill adults over 50 in the ICU who are expected to need a ventilator for at least 48 hours and can consent through a representative. They must speak English, have phone access, and not have hearing/vision impairments, certain neurological conditions, uncontrolled psychiatric illness, or be at risk of alcohol/drug withdrawal.

Inclusion Criteria

I am 50 years old or older.

You are expected to need a breathing machine for 48 hours or more.

English speaking

Exclusion Criteria

You are experiencing symptoms of alcohol withdrawal or there is concern that you may experience withdrawal.

Enrolled in another clinical trial which does not permit co-enrollment

Uncorrected hearing or vision impairment including legal blindness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a seven-day slow-tempo music intervention to evaluate its efficacy on delirium/coma free days

7 days

Daily sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, cognition, depression, and anxiety

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control
• Slow Tempo Music

Trial Overview The study tests if slow-tempo music can reduce delirium/coma days in older adults on mechanical ventilation in the ICU. It's a randomized controlled trial where participants either receive attention control or listen to slow-tempo music daily for seven days.

How Is the Trial Designed?

Group I: Slow Tempo Music Experimental Treatment 1 Intervention

Slow-tempo 60-80 beats per minute relaxing music. The intervention includes two one-hour music listening sessions, once in the morning and once in the evening for up to seven days, delivered through noise-canceling headphones and iPad.

Group II: Attention Control Placebo Group 1 Intervention

One-hour sessions consisting of a silence track twice daily delivered through noise-cancelling headphones for up to 7 days.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. regenstrief.org regenstrief.org/article/slow-tempo-relaxing-music-to-address-delirium/

Slow-tempo relaxing music to address delirium in ill older ... Refines practice: Findings counter the assumption that early, slow-tempo playlists via headphones will improve delirium/coma-free days in the ICU. Advances ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9295531/

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

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04182334

Decreasing Delirium Through Music in Critically Ill Older ... Music listening is a non-pharmacological intervention that has shown to decrease over-sedation, anxiety and stress in critically ill patients.

4. mayo.edu mayo.edu/research/clinical-trials/cls-20537141

Decreasing Delirium in Critically Ill Older Adults Through ... The purpose of this study is to evaluate the effectiveness of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among ...

5. elischolar.library.yale.edu elischolar.library.yale.edu/cgi/viewcontent.cgi?article=1196&context=ysmpa_theses

The Effect of Slow Tempo Music Listening on Incidence of ... treatment of delirium in mechanically ventilated intensive care unit (ICU) patients have shown to reduce length of mechanical ventilation ...

6. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/article-abstract/2840194

Slow-Tempo Music and Delirium/Coma-Free Days Among ... This randomized clinical trial aims to determine if a slow-tempo music (60-80 beats/min) listening intervention decreases delirium duration, ...

7. 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.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1036731424002996

A systematic review of the comparative effects of sound ... Our review demonstrated that both slow-tempo music and sound interventions can significantly (i) decrease pain; (ii) improve sleep; (iii) regulate cortisol ...