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Completed

NCT Number: NCT03095443

Decreasing Delirium Through Music

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Therapy - Personalized Playlist

Other

Participant receives personalized playlist.

Music Therapy - Standard Playlist

Other

Participant receives a standard low beats per minute playlist.

Attention Control

Other

Participant receives an audio-book.

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Regenstrief Institute, Inc.

Registry information

Acronym: DDM

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 29, 2017
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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