Clinical trial NCT03095443: Decreasing Delirium Through Music
Official title: Decreasing Delirium Through Music
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: Delirium
Critical Illness
Music Therapy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Regenstrief Institute, Inc.
First posted: 2017-03-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rates
timeFrame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
measure: Intervention adherence
timeFrame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
measure: Participant retention
timeFrame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
Secondary outcomes:
measure: Estimate the potential effect size
timeFrame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
Study officials:
References:
citation: Khan SH, Wang S, Harrawood A, Martinez S, Heiderscheit A, Chlan L, Perkins AJ, Tu W, Boustani M, Khan B. Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial. Trials. 2017 Nov 29;18(1):574. doi: 10.1186/s13063-017-2324-6.