Delirium Clinical Trial
Official title:
Decreasing Delirium Through Music
DDM is a study designed to Test the efficacy of personalized music therapy in reducing delirium incidence and severity among patients admitted to the Intensive Care Unit.
Over 1 million adults are admitted to the intensive care unit and placed on mechanical
ventilation on an annual basis. Intravenous sedatives and analgesics are commonly
administered to these patients to reduce pain and anxiety. While the recent reduction in
benzodiazepine usage has helped reduced ICU-related acute brain dysfunction (delirium), up to
80% of ventilated patients still develop acute brain failure. This is characterized by
disturbance of consciousness with reduced ability to focus, sustain or shift attention,
occurring over a short period of time and fluctuating over the course of a day.
Acute brain dysfunction has both short-term and long-term health impacts. It is associated
with increased hospital length of stay, increased in-hospital mortality and post-discharge
mortality as well increased health-care costs. Patients who experience delirium are at
greater risk for post-discharge institutionalization and newly acquired cognitive impairment
similar to dementia.
Despite the prevalence and morbidity associated with delirium, there is a scarcity of
effective pharmacological and non-pharmacological interventions to prevent and treat this
condition. While music therapy has shown to reduce anxiety and stress in cancer and dementia
patients, these studies were performed outside the intensive care unit. It is hypothesized
that music lowers inflammatory mediators such as cytokines and cortisol. Delirium
pathophysiology similar to anxiety has a strong inflammatory component with excess of
pro-inflammatory cytokines such as interleukins 1, 6, and 8. Given the beneficial effects of
music in reducing inflammatory mediators, it stands to reason that such intervention will
have a beneficial impact on reducing delirium.
The investigators propose a randomized, three-group (personalized music intervention versus
generic music intervention versus attention control) trial to test the feasibility and
efficacy of music therapy in reducing delirium incidence, duration, and severity among
critically ill patients in the ICU.
Our study focuses on the effect of music therapy on the incidence and severity of delirium in
the intensive care unit at a large urban academic health center.
The investigators hypothesize that music therapy will lead to reduced levels of anxiety,
delirium and need for sedating medications, leading to shorter hospital stays.
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