N/A
N=159
Decreasing Delirium Through Music in Critically Ill Older Adults
Intensive Care Unit Delirium · Pain · Anxiety · Intensive Care Acquired Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT04182334 ↗Enrolled (actual)
159
Serious AEs
0.6%
Results posted
Jan 2025
Primary outcome: Primary: Days Free of Delirium and Coma — 2.5; 3 Delirium/coma-free days by day 7 — p=0.775
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Slow Tempo Music (Other); Attention Control (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days Free of Delirium and Coma |
2.5; 3 | 0.775 |
| SECONDARY Delirium Severity |
5.43; 5.79; 4.77; 5.51; 4.10; 4.45 | 0.995 |
| SECONDARY Pain Intensity |
0.42; 0.30; 0.34; 0.34; 0.32; 0.21 | 0.674 |
| SECONDARY Anxiety |
2.46; 5.94 | 0.196 |
| SECONDARY Cognition |
32.31; 34.13 | 0.612 |
| SECONDARY Cognition |
32.31; 34.13 | 0.612 |
| SECONDARY Cognition |
32.31; 34.13 | 0.612 |
| SECONDARY Cognition |
32.31; 34.13 | 0.612 |
| SECONDARY Depression |
3.38; 7.50 | 0.058 |
| SECONDARY Anxiety |
2.46; 5.94 | 0.196 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Age 50 years or older.
- English speaking.
- Admitted to the intensive care unit (medical or surgical).
- Expected mechanical ventilator support for ≥48 hours.
- Consentable through a legally authorized representative.
- Have access to a telephone.
Exclusion Criteria
- History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease or vascular dementia.
- Psychiatric illness which is not well controlled.
- Alcohol withdrawal symptoms/concern for withdrawal.
- Suspected or confirmed drug intoxication/overdose
- Traumatic brain injury, ischemic or hemorrhagic cerebrovascular accident, or undergoing neurosurgery.
- Uncorrected hearing or vision impairment including legal blindness.
- Incarcerated at the time of study enrollment.
- Enrolled in another clinical trial which does not permit co-enrollment.
- Any medical condition precluding safe use of headphones such as: skin breakdown, burns, facial or skull fractures.
Data sourced from ClinicalTrials.gov (NCT04182334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.