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Decreasing Delirium Through Music

Decreasing Delirium Through Music

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03095443
Acronym
DDM
Enrollment
56
Registered
2017-03-29
Start date
2016-12-01
Completion date
2018-12-31
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Delirium, Critical Illness, Music Therapy

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.

Interventions

OTHERMusic Therapy - Personalized Playlist

Participant receives personalized playlist.

OTHERMusic Therapy - Standard Playlist

Participant receives a standard low beats per minute playlist.

OTHERAttention Control

Participant receives an audio-book.

Sponsors

Regenstrief Institute, Inc.
CollaboratorOTHER
Indiana University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Recruitment ratesDate of study enrollment through discharge from ICU, or date of study enrollment up to 28 daysthe number of participants approached and their rates of consent
Intervention adherenceDate of study enrollment through discharge from ICU, or date of study enrollment up to 28 daysnumber of listening sessions completed per patient
Participant retentionDate of study enrollment through discharge from ICU, or date of study enrollment up to 28 daysNumber of patients who complete the study.

Secondary

MeasureTime frameDescription
Estimate the potential effect sizeDate of study enrollment through discharge from ICU, or date of study enrollment up to 28 daysPatient-preferred music association with reducing delirium incidence as measured by CAM-ICU.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026