A multi-center randomized controlled trial with critically ill adults aged 50 years and older admitted to intensive care units (ICUs) found that twice-daily slow-tempo music (60 to 80 beats per minute) did not shorten the duration of delirium or coma, or reduce delirium severity, pain or anxiety compared with a silence-track control.
While the trial did not mitigate delirium, it showed a trend to fewer days with delirium/coma among patients who received at least seven doses of slow-tempo music. There was also a trend toward fewer days of delirium/coma among patients who had received benzodiazepines, a type of sedative that increases the risk of delirium. These results suggest the need for further study of music as an adjunctive therapy in critically ill older adults.
Delirium is a state of confusion and has serious short and long-term health consequences including an increased risk of post-ICU dementia. About 75 percent of older adults develop delirium in the ICU.
The Decreasing Delirium through Music in Critically Ill Older Adults (DDM) Trial was conducted at Indiana University School of Medicine-affiliated hospitals (Indiana University Health and Sidney and Lois Eskenazi Hospital, Indianapolis) and Mayo Clinic, Rochester, Minnesota. The team included researchers from IU School of Medicine, Mayo Clinic, Regenstrief Institute, Anglia Ruskin University and Area 10 Labs.
The two-arm trial featured concealed outcome assessments and compared a carefully curated selection of slow-tempo music vs. silence-track control. Listening sessions in both arms were delivered twice daily for up to seven days via computer tablets and over-the-ear active noise-cancelling headphones. The DDM Trial demonstrated the feasibility of centralized, app-based, music playlist delivery and in the busy ICU environment.
The study, "Slow-Tempo Music and Delirium/Coma-Free Days Among Older Adults Undergoing Mechanical Ventilation: A Randomized Controlled Trial," is published in the Journal of the American Medical Association's JAMA Internal Medicine.
"Despite the intuitive appeal of calming music in the ICU, our rigorously conducted multi-center trial shows prescribed slow-tempo playlists did not reduce delirium, pain or anxiety, nor change length of ventilation or stay," said Babar Khan, M.D., M.S., co-lead author. "These data refine practice and suggest future studies focus on personalized, therapist-guided approaches and targeted populations."
Linda L. Chlan, PhD, R.N., Mayo Clinic and co-lead investigator, added, "We conceptualized music as a meaningful, complex stimulus to activate the brain among ICU patients. It is possible that a prescribed selection of music was not meaningful to patients which highlights the importance of music preferences in designing future clinical trials."
"In DDM, we were able to demonstrate it's feasible to deliver and track music 'dose' reliably in critically ill patients using an app," said Sikandar Khan, D.O., M.S., co-lead author, "Our post hoc analyses, while exploratory, show a trend towards greater coma-free days in patients who were in the ICU long enough to receive seven days of intervention, and those patients who had received benzodiazepines. This raises new questions about the interaction between sedation and the effect of slow-tempo music."
- Refines practice: Findings counter the assumption that early, slow-tempo playlists via headphones will improve delirium/coma-free days in the ICU.
- Advances evidence: Adds rigorous, multi-center randomized trial data with concealed outcomes assessment to a field where many pharmacologic delirium trials have also been negative.
- Guides future research: The findings suggest that future studies should evaluate longer duration, targeted subgroups (e.g., specific sedation profiles), or post-ICU timing of music intervention. Non-significant trends in those receiving at least seven sessions and in benzodiazepine-exposed patients suggest potential subpopulations for study.
- Demonstrates feasibility and fidelity: This is the first trial to use the Soundese iPad app to deliver/track music "dose," establishing a scalable model for intervention fidelity in ICU behavioral trials.
- Confirms safety and implementation: There were no serious adverse events; adherence and timing windows were reliable, informing practical deployment parameters even if efficacy was not shown.
Authors and affiliations, as listed in the publication
Babar A. Khan, MD, MS;*1,2,3 Sikandar H. Khan, DO, MS;*1,2,3 Anthony J. Perkins, MS;4 Annie Heiderscheit, PhD;5 Frederick W. Unverzagt, MD;6 Sophia Wang, MD;6 J. Hunter Downs III, PhD;7.8 Sujuan Gao, PhD;4 Linda L. Chlan, PhD, RN, ATSF, FAAN7, 9
*Co-First Author
1Indiana University School of Medicine, Indianapolis, IN
2Indiana University Center for Aging Research, Indianapolis, IN
3Regenstrief Institute, Inc., Indianapolis, IN
4Department of Biostatistics and Health Data Science, Indiana University School of Medicine, Indianapolis, IN
5Anglia Ruskin University, Cambridge, UK
6Department of Psychiatry, Indiana University School of Medicine, Indianapolis, Indiana
7Mayo Clinic, Rochester, MN
8Area10 Labs, LLC, Rochester, MN
9Mayo Clinic College of Medicine and Science, Rochester, MN
Funding/Support: Source of Funding
The study was supported by a grant from the National Institutes of Health's National Institute on Aging (NIA R01AG067631), awarded to Dr. Babar Khan and Dr. Linda Chlan.
