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Trials. 2017 Nov 29;18(1):574. doi: 10.1186/s13063-017-2324-6.

Decreasing Delirium through Music (DDM) in critically ill, mechanically ventilated patients in the intensive care unit: study protocol for a pilot randomized controlled trial.

Author information

1
Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. sikhan@iu.edu.
2
IU Center of Aging Research, Regenstrief Institute, Indianapolis, IN, USA. sikhan@iu.edu.
3
Department of Psychiatry, Indiana University School of Medicine, Indianapolis, IN, USA.
4
Indiana University Center of Health Innovation and Implementation Science, Indianapolis, IN, USA.
5
IU Center of Aging Research, Regenstrief Institute, Indianapolis, IN, USA.
6
Music Therapy Department, Augsburg College, Minneapolis, MN, USA.
7
Department of Nursing, Nursing Research Division, Mayo Clinic, Rochester, MN, USA.
8
Indiana Clinical and Translational Research Institute, Indiana University School of Medicine, Indianapolis, IN, USA.
9
Department of Biostatistics, Indiana University School of Medicine, Indianapolis, IN, USA.
10
Sandra Eskenazi Center for Brain Care Innovation, Eskenazi Hospital, Indianapolis, IN, USA.
11
Division of Geriatrics and General Internal Medicine, Department of Internal Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
12
Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.

Abstract

BACKGROUND:

Delirium is a highly prevalent and morbid syndrome in intensive care units (ICUs). Changing the stressful environment within the ICU via music may be an effective and a scalable way to reduce the burden of delirium.

METHODS/DESIGN:

The Decreasing Delirium through Music (DDM) study is a three-arm, single-blind, randomized controlled feasibility trial. Sixty patients admitted to the ICU with respiratory failure requiring mechanical ventilation will be randomized to one of three arms (20 participants per arm): (1) personalized music, (2) non-personalized relaxing music, or (3) attention-control. Music preferences will be obtained from all enrolled participants or their family caregivers. Participants will receive two 1-h audio sessions a day through noise-cancelling headphones and mp3 players. Our primary aim is to determine the feasibility of the trial design (recruitment, adherence, participant retention, design and delivery of the music intervention). Our secondary aim is to estimate the potential effect size of patient-preferred music listening in reducing delirium, as measured by the Confusion Assessment Method for the ICU (CAM-ICU). Participants will receive twice daily assessments for level of sedation and presence of delirium. Enrolled participants will be followed in the hospital until death, discharge, or up to 28 days, and seen in the Critical Care Recovery Clinic at 90 days.

DISCUSSION:

DDM is a feasibility trial to provide personalized and non-personalized music interventions for critically ill, mechanically ventilated patients. Our trial will also estimate the preliminary efficacy of music interventions on reducing delirium incidence and severity.

TRIAL REGISTRATION:

ClinicalTrials.gov, Identifier: NCT03095443 . Registered on 23 March 2017.

KEYWORDS:

Critical care; Delirium; Music

PMID:
29187230
PMCID:
PMC5708104
DOI:
10.1186/s13063-017-2324-6
[Indexed for MEDLINE]
Free PMC Article

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