Decreasing Delirium Through Music (DDM)

April 16, 2019 updated by: Babar Khan, MD, MS, Indiana University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Eskenazi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rates
Time Frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
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
Time Frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
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
Time Frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
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
Time Frame: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Regenstrief Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 29, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 16, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1608887741

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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