A multi-center, randomized controlled trial investigating the use of slow-tempo music to alleviate delirium in critically ill older adults found that the intervention did not significantly shorten the duration of delirium or coma. The study, which involved patients aged 50 and older in intensive care units (ICUs), also showed no significant reduction in the severity of delirium, pain, or anxiety when compared to a control group that listened to a silence track.
Despite the primary outcomes not reaching statistical significance, researchers observed some encouraging trends that suggest music may still hold promise as a non-pharmacological treatment for delirium. Specifically, patients who received at least seven doses of the music intervention showed a tendency toward fewer days spent in a state of delirium or coma. A similar trend was noted among patients who were also being treated with benzodiazepines, a class of sedatives known to increase the risk of delirium. These secondary findings indicate that further research is warranted to explore the potential benefits of music therapy in specific subgroups of critically ill patients.
A Complex Neurological Challenge in Intensive Care
Delirium is an acute state of confusion and cognitive impairment that is a common and serious complication for patients in the ICU. Affecting as many as 75% of older adults in critical care settings, delirium is associated with a range of negative outcomes, including prolonged hospital stays, increased risk of mortality, and a higher likelihood of developing long-term cognitive issues such as dementia after leaving the hospital. The condition presents as a fluctuating disturbance in attention, awareness, and cognition, making it a significant challenge for clinicians to manage. The search for safe, effective, and non-pharmacological interventions to prevent or reduce the duration of delirium is a priority in critical care medicine.
Methodology of the DDM Trial
The Decreasing Delirium through Music in Critically Ill Older Adults (DDM) Trial was designed to rigorously test the efficacy of a music-based intervention. The study was conducted at hospitals affiliated with the Indiana University School of Medicine and at the Mayo Clinic in Rochester, Minnesota. Researchers from several institutions, including the Regenstrief Institute, Anglia Ruskin University, and Area 10 Labs, collaborated on the project. The trial was a two-arm, randomized controlled study with concealed outcome assessments, ensuring that those evaluating the patients for delirium were unaware of which group the patients were in.
Intervention and Control Groups
Participants in the intervention group were exposed to a carefully selected playlist of slow-tempo instrumental music, with a rhythm of 60 to 80 beats per minute, for one hour, twice a day. The music was delivered through noise-canceling headphones connected to a computer tablet. This intervention was administered for up to seven consecutive days. Patients were also able to initiate listening sessions on their own if they wished. The control group received the same treatment in terms of duration and delivery method, but instead of music, they were exposed to a “silence track.”
Data Collection and Analysis
The primary outcome measured was the number of delirium/coma-free days after randomization. This is a standard measure in delirium research that accounts for both the presence of delirium and the level of consciousness. The research team used an iPad application to deliver the intervention and to automatically log the frequency and duration of the listening sessions, for both the prescribed sessions and any self-initiated listening by the patients. This technological approach helped to ensure the consistency and accurate tracking of the intervention.
Primary Outcomes and Key Findings
The main finding of the DDM Trial was that the slow-tempo music intervention did not produce a statistically significant increase in the number of delirium/coma-free days compared to the silence-track control group. Additionally, the study found no significant differences between the two groups in terms of the severity of delirium, or in patient-reported levels of pain and anxiety. These results challenge the hypothesis that a generalized application of slow-tempo music can broadly mitigate delirium in this vulnerable patient population and highlight the complexity of treating this condition.
Subgroup Analysis Reveals Nuances
While the primary endpoint was not met, the researchers did identify some potentially important signals in their secondary analysis. A trend towards a reduction in the number of days with delirium or coma was observed in two specific subgroups. The first of these was the group of patients who were able to receive at least seven doses of the music intervention. The second subgroup showing this positive trend consisted of patients who had also been administered benzodiazepines. This is particularly interesting because benzodiazepines are known to be a risk factor for developing delirium. The finding suggests that music might have a counteracting or protective effect in these patients, although more research is needed to confirm this.
Implications for Future Research and Clinical Practice
The results of the DDM Trial suggest that while slow-tempo music may not be a universal solution for delirium in the ICU, it could have benefits for certain patients or under specific conditions. The study’s authors call for more research to explore these possibilities. Future studies might focus on the subgroups that showed a positive trend in this trial. It is also possible that different types of music, or music interventions that are more personalized to the patient’s preferences, could yield different results. The trial’s findings underscore the need for refined and personalized approaches to delirium management.
Feasibility of Technology-Based Interventions
A significant success of the DDM Trial was its demonstration of the feasibility of implementing a technology-based intervention in the demanding environment of an ICU. The use of a centralized, app-based system for delivering the music and silence tracks proved to be a reliable and effective method. The high feasibility and acceptability rates, with 80% in each arm of a pilot study, show that such interventions can be successfully integrated into the workflow of a busy critical care setting. This provides a solid foundation for future research into this and other similar non-pharmacological interventions for critically ill patients.
