Music Therapy for ICU Delirium

(DDM Trial)

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

160 Participants Needed

Trial Summary

What is the purpose of this trial?

Critically ill older adults admitted to the intensive care unit (ICU) are at a higher risk to develop delirium, which predisposes them to longer lengths of ICU and hospital stay, increased in-patient mortality, and higher risk of new acquired cognitive impairment and dementia. Music listening is a non-pharmacological intervention that holds potential to decrease ICU delirium. The investigators propose a randomized controlled trial to evaluate the efficacy of a seven-day slow-tempo music intervention on the primary outcome of delirium/coma free days among mechanically ventilated, critically ill older adults.

Research Team

Linda Chlan, PhD, RN

Principal Investigator

Mayo Clinic

Babar Khan, MD, MS

Principal Investigator

Indiana University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+