Decreasing Delirium Through Music

Delirium Clinical Trial

— DDM  

Official title:

Decreasing Delirium Through Music

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095443
• Other study ID #: 1608887741
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• Music Therapy - Personalized Playlist
Participant receives personalized playlist.
• Music Therapy - Standard Playlist
Participant receives a standard low beats per minute playlist.
• Attention Control
Participant receives an audio-book.

Locations

Country	Name	City	State
United States	Eskenazi Hospital	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Regenstrief Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rates	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
Primary	Intervention adherence	number of listening sessions completed per patient	Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days
Primary	Participant retention	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	Estimate the potential effect size	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