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临床试验/NCT03095443
NCT03095443已完成不适用

Decreasing Delirium Through Music

Indiana University2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
2
主要终点
Recruitment rates

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 18 years or older
  • English speaking
  • admitted to the intensive care unit (medical or surgical)
  • receiving mechanical ventilation

排除标准

  • 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.

研究组 & 干预措施

Non Personalized Music

Active Comparator

Receives standardized low beats per minute playlist twice a day.

干预措施: Music Therapy - Standard Playlist (Other)

Personalized Music

Experimental

Receives personalized playlist twice a day.

干预措施: Music Therapy - Personalized Playlist (Other)

Attention Control

Active Comparator

Receives audio-book twice a day.

干预措施: Attention Control (Other)

结局指标

主要结局

Recruitment rates

时间窗: 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

Intervention adherence

时间窗: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days

number of listening sessions completed per patient

Participant retention

时间窗: Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days

Number of patients who complete the study.

次要结局

  • Estimate the potential effect size(Date of study enrollment through discharge from ICU, or date of study enrollment up to 28 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Babar Khan, MD, MS

Assistant Professor of Medicine

Indiana University

研究点 (2)

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