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临床试验/NCT04977011
NCT04977011已完成不适用

Effectiveness of Music Intervention on Anxiety in Critical Ill Patient: Randomized Controlled Trial

Min-Sheng General Hospital1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2019年1月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
196
试验地点
1
主要终点
Anxiety Visual Analog Scale.

研究概览

简要总结

Music intervention is a non-pharmacological and effective intervention that can alleviate anxiety and agitation in patients undergoing weaning. The effectiveness of music intervention in reducing anxiety of patients in Intensive Care Unit (ICU) is still unknown. The purpose of this study was to examine the effectiveness of music intervention on anxiety, agitation, sleep quality and physiological parameters on patients in ICU. This study was conducted from January to June 2019. A total of 196 hospitalized ICU patients were divided into two groups. Subjects in experimental group received 30 minutes music intervention for 3 days on bedside whereas subjects in control group received routine care only. The primary outcome was anxiety. Agitation Sedation Scale, sleep quality and physical parameters were selected to collect as secondary outcomes.There was no significant difference between the groups at baseline. The results of this study support that music can reduce anxiety and agitation levels in ICU's patient. Nurses can incorporate this intervention into the daily care in order to reduce the discomfort of patients.

详细描述

Background:Music intervention is a non-pharmacological and effective intervention that can alleviate anxiety and agitation in patients undergoing weaning. The effectiveness of music intervention in reducing anxiety of patients in ICU is still unknown.

Objectives: The purpose of this study was to examine the effectiveness of music intervention on anxiety, agitation, sleep quality and physiological parameters on patients in ICU.

Methods: This study was conducted from January to June 2019. A total of 196 hospitalized ICU patients were divided into two groups. Subjects in experimental group received 30 minutes music intervention for 3 days on bedside whereas subjects in control group received routine care only. The primary outcome was anxiety measured by Visual Analog Scale. Richmond Agitation Sedation Scale, Richards-Campbell Sleep Scale and their physical parameters were selected to collect the secondary outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 102 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 20 years or older and staying in an intensive care unit.
  • Patients within 24 hours of admission (Acute Physiology And Chronic Health Evaluation, APACHE II score) ≦25 points.
  • Can express their intentions by writing or shaking their heads.
  • Can communicate in Mandarin, Taiwanese, Hakka or English.
  • After explaining the purpose of the research, agree to participate and fill out the consent form.

排除标准

  • Dementia or mental illness are recorded

结局指标

主要结局

Anxiety Visual Analog Scale.

时间窗: 3day

The Visual Analogue Scale for Anxiety (VASA) is a line 10 centimetres in length with "not at all anxious" and "very anxious" at the left and right extremes respectively.

次要结局

  • Richmond Agitation Sedation Scale(3 day)
  • Richards-Campbell Sleep Scale(3 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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