Decreasing Delirium Through Music (DDM)
Primary Purpose
Delirium
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy - Personalized Playlist
Music Therapy - Standard Playlist
Attention Control
Sponsored by
About this trial
This is an interventional prevention trial for Delirium focused on measuring Delirium, Critical Illness, Music Therapy
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.
Sites / Locations
- Eskenazi Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Personalized Music
Non Personalized Music
Attention Control
Arm Description
Receives personalized playlist twice a day.
Receives standardized low beats per minute playlist twice a day.
Receives audio-book twice a day.
Outcomes
Primary Outcome Measures
Recruitment rates
the number of participants approached and their rates of consent
Intervention adherence
number of listening sessions completed per patient
Participant retention
Number of patients who complete the study.
Secondary Outcome Measures
Estimate the potential effect size
Patient-preferred music association with reducing delirium incidence as measured by CAM-ICU.
Full Information
NCT ID
NCT03095443
First Posted
March 23, 2017
Last Updated
April 16, 2019
Sponsor
Indiana University
Collaborators
Regenstrief Institute, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03095443
Brief Title
Decreasing Delirium Through Music
Acronym
DDM
Official Title
Decreasing Delirium Through Music
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Regenstrief Institute, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Delirium, Critical Illness, Music Therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Personalized Music
Arm Type
Experimental
Arm Description
Receives personalized playlist twice a day.
Arm Title
Non Personalized Music
Arm Type
Active Comparator
Arm Description
Receives standardized low beats per minute playlist twice a day.
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
Receives audio-book twice a day.
Intervention Type
Other
Intervention Name(s)
Music Therapy - Personalized Playlist
Intervention Description
Participant receives personalized playlist.
Intervention Type
Other
Intervention Name(s)
Music Therapy - Standard Playlist
Intervention Description
Participant receives a standard low beats per minute playlist.
Intervention Type
Other
Intervention Name(s)
Attention Control
Intervention Description
Participant receives an audio-book.
Primary Outcome Measure Information:
Title
Recruitment rates
Description
the number of participants approached and their rates of consent
Time Frame
Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
Title
Intervention adherence
Description
number of listening sessions completed per patient
Time Frame
Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
Title
Participant retention
Description
Number of patients who complete the study.
Time Frame
Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
Secondary Outcome Measure Information:
Title
Estimate the potential effect size
Description
Patient-preferred music association with reducing delirium incidence as measured by CAM-ICU.
Time Frame
Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29187230
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.
Results Reference
derived
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Decreasing Delirium Through Music
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