Decreasing Delirium Through Music

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Decreasing Delirium Through Music

Conditions
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Delirium

Intervention / Treatment
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* Other: Music Therapy - Personalized Playlist
* Other: Music Therapy - Standard Playlist
* Other: Attention Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older English speaking admitted to the intensive care unit (medical or surgical) receiving mechanical ventilation Exclusion Criteria: history of dementia psychiatric illness which is not well controlled alcohol withdrawal symptoms/concern for withdrawal suspected or confirmed drug intoxication/overdose traumatic brain injury hearing or vision impairment including legal blindness aphasic stroke coma after cardiac arrest/hypothermia protocol pregnant or nursing prisoners patients enrolled in another clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized Music<br>Receives personalized playlist twice a day. | Other: Music Therapy - Personalized Playlist<br>* Participant receives personalized playlist.<br>|
| Active Comparator: Non Personalized Music<br>Receives standardized low beats per minute playlist twice a day. | Other: Music Therapy - Standard Playlist<br>* Participant receives a standard low beats per minute playlist.<br>|
| Active Comparator: Attention Control<br>Receives audio-book twice a day. | Other: Attention Control<br>* Participant receives an audio-book.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rates | the number of participants approached and their rates of consent | Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days | 
| Intervention adherence | number of listening sessions completed per patient | Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days | 
| Participant retention | Number of patients who complete the study. | Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the potential effect size | Patient-preferred music association with reducing delirium incidence as measured by CAM-ICU. | Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Critical Illness, Music Therapy