跳至主要内容
临床试验/NCT03280329
NCT03280329Unknown不适用

Music Therapy in the ICU as a Tool to Reduce Neuroactive Drugs: Generalized Versus Personalized Intervention

University of Milan2 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
153
试验地点
2
主要终点
Neuroactive drug free days

研究概览

简要总结

Admission to an Intensive Care Unit (ICU) is one of the major causes of stress and both physical and emotional difficulties for critically ill patients, both because of the illness that caused the admission and of the ICU nevironment itself. Despite the use of protocols and tools to evaluate sedation, many patients continue to have high levels of anxiety. An inadequate treatment of this condition is associated with increased sympathetic activity which causes dyspnea and an increase in myocardial oxygen consumption. Sedative drugs, on the other side, may have significant side effects.

In view of this, there is clear need to find new strategies and instruments allowing for the maximization of critical patients' comfort, by promoting pain, anxiety, stress and agitation relief and minimising the need of sedative therapy.

The main hypothesis of this study is that the use of music therapy for critically ill patients can lead to a significant increase of the days free from neuroactive therapy (analgesics, sedatives, antianxiety meds, antipsychotics) in the first 28 days following Intensive Care Unit admission. To this purpose, data obtained from 3 groups of patients will be compared - a group with individual treatment administered by a music therapist and delivered by headphones, a group with a generalised treatment, through the creation of a weekly musical program continuously broadcasted in the hospital room, and a control group.

详细描述

Introduction The Intensive Care Unit (ICU) is one of the major causes of stress and both physical and emotional difficulties for patients and their families.

Studies have been conducted in the investigators' and other Intensive Care Units and they set out to investigate main causes of stress in critical patients; among the most significant factors were shown to be life saving treatment such as mechanical ventilation, invasive procedures, restriction of movement, pain and inability to verbally express it, environment characterized by constant light and sound stimulation, loss of interaction with loved ones and the staff, and sleep deprivation.

Despite the use of protocols and tools to evaluate sedation, many patients continue to have high levels of anxiety. An inadequate treatment of this condition is associated with increased sympathetic activity which causes dyspnea and an increase in myocardial oxygen consumption.

In view of it, there is clear need to find new strategies and instruments allowing for the maximization of critical patients' comfort, by promoting pain, anxiety, stress and agitation relief and minimising the need of sedative therapy.

Among non pharmacological treatment, hypnosis and relaxation techniques, implementation of communication with patient, music therapy and physical support are shown to be effective (7).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • all patients hospitalized in Intensive Care for any medical, surgical traumatic condition, whose stay in the ICU is expected to be longer than 2 days

排除标准

  • expected Glascow Goma Scale at ICU discharge lower than 12
  • hearing impairment

结局指标

主要结局

Neuroactive drug free days

时间窗: one year

the outcome will be calculated giving one point for each day during the measurement period that patients are both alive and free the administration of any neuroactive drug

次要结局

  • Sedative exposure(one year)
  • reduction of the stress associated to ICU stay(one year)

研究者

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

Giovanni Mistraletti

University researcher

University of Milan

研究点 (2)

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