Clinical Trial: Decreasing Delirium Through Music
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Decreasing Delirium Through Music
Brief Summary: 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.
Detailed Summary:
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 (per
Sponsor: Indiana University
Current Primary Outcome:
- Count of participants who experience delirium [ Time Frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days ]Number of patients in each arm who experience delirium during their stay as identified by the Confusion Assessment Method for the ICU (CAM-ICU).
- Average severity of delirium [ Time Frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days ]Average score on Confusion Assessment Method for the ICU (CAM-ICU) 7 per study arm.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Indiana University
Dates:
Date Received: March 23, 2017
Date Started: December 1, 2016
Date Completion: December 31, 2018
Last Updated: March 29, 2017
Last Verified: March 2017
