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Music Therapy for ICU Delirium (DDM Trial)

N/A

Waitlist Available

Led By Linda Chlan, PhD, RN

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 50 years or older

Admitted to the intensive care unit (medical or surgical)

Must not have

History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia

Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post hospital discharge

Summary

This trial will study whether a seven-day slow-tempo music intervention can decrease delirium/coma free days among mechanically ventilated, critically ill older adults.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves listening to music, side effects are minimal but may include discomfort from wearing headphones or emotional responses to music. The study excludes those with conditions that could make headphone use unsafe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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I am currently in the ICU.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of Alzheimer's or similar memory disorders.

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I don't have conditions that prevent me from safely using headphones.

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I have had a brain injury, stroke, or brain surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post hospital discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post hospital discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Days free of delirium and coma

Secondary study objectives

Anxiety

Cognition

Delirium Severity

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Slow Tempo MusicExperimental Treatment1 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 ControlPlacebo Group1 Intervention

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

0 / 5Eligibility criteria met