Decreasing Delirium Through Music

NCT ID: NCT03095443

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2018-12-31

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.

Conditions

Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Personalized Music

Receives personalized playlist twice a day.

Group Type: EXPERIMENTAL

Music Therapy - Personalized Playlist

Intervention Type: OTHER

Participant receives personalized playlist.

Non Personalized Music

Receives standardized low beats per minute playlist twice a day.

Group Type: ACTIVE_COMPARATOR

Music Therapy - Standard Playlist

Intervention Type: OTHER

Participant receives a standard low beats per minute playlist.

Attention Control

Receives audio-book twice a day.

Group Type: ACTIVE_COMPARATOR

Attention Control

Intervention Type: OTHER

Participant receives an audio-book.

Interventions

Music Therapy - Personalized Playlist

Participant receives personalized playlist.

Intervention Type: OTHER

Music Therapy - Standard Playlist

Participant receives a standard low beats per minute playlist.

Intervention Type: OTHER

Attention Control

Participant receives an audio-book.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regenstrief Institute, Inc.

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Babar Khan, MD, MS

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eskenazi Hospital

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29187230 (View on PubMed)

Other Identifiers

1608887741

Identifier Type: -

Identifier Source: org_study_id