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临床试验/NCT05102084
NCT05102084已完成不适用

The Effect of Listening to Music During CPAP on the Agitation Levels and Compliance With CPAP of Intensive Care Patients With COVID-19: A Randomized Controlled Trial

SÜMEYYE BİLGİLİ2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
Compliance with CPAP

研究概览

简要总结

Aim: This study was conducted to determine the effect of listening to music during CPAP on the agitation levels of intensive care patients who underwent CPAP due to COVID-19 and their compliance with the treatment.

Study Design: This study is a prospective, randomized, controlled clinical trial. Seventy-six intensive care patients with COVID-19 were included in this study and assigned to the music and control groups via the block randomization method. The study was completed with 70 patients. In this study, the patients and outcome assessors were not blinded. The Richmond Agitation and Sedation Scale (RASS) level, respiratory rate, oxygen saturation (SpO2), and mask air leakage amount were the result criteria.

Results: The mean RASS score of the patients in the intervention group was 2.14±0.69 before CPAP, 1.63±064 at the 1st minute, 0.89±0.58 at the 15th minute, and 0.74±0.61 at the 30th minute. The mean RASS score of the patients in the control group was 2.06±0.53 before CPAP, 1.80±0.58 at the 1st minute, 1.43±0.60 at the 15th minute, and 1.46±0.61 at the 30th minute of CPAP. There was a statistically significant difference between the groups at the 15th and 30th minutes (t=-3.81, p < .001; t=-4.89, p < .001, respectively).

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
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

  • over 18 years old
  • Received CPAP treatment for 1 day in the intensive care unit,
  • Not hearing impaired,
  • No sedation treatment
  • Not diagnosed with a psychiatric illness,
  • Hemodynamically stable,
  • Not taking drugs (such as digoxin, adrenaline, dopamine) that affect blood pressure and pulse rate
  • Patients with a Glasgow Coma Scale score of 14 and above will be accepted.

排除标准

  • The patient's desire to leave the study
  • be under the age of 18
  • putting the patient on mechanical ventilation
  • have a hearing impairment
  • Receiving sedation therapy
  • diagnosed with psychiatric illness
  • Using drugs (such as digoxin, adrenaline, dopamine) that affect blood pressure and pulse rate
  • Patients with a Glasgow Coma Scale score below 14 will not be included in the study.

结局指标

主要结局

Compliance with CPAP

时间窗: 30 minutes

Measure of respiratory rate, oxygen saturation,mask air leakage amount

Changes in agitation level

时间窗: 30 minutes

The agitation levels of patients were monitored with the Richmond Agitation and Sedation Scale

次要结局

  • Variation of agitation and CPAP compliance with time(30 minutes)

研究者

发起方
SÜMEYYE BİLGİLİ
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

SÜMEYYE BİLGİLİ

Nursing Fundamentals Graduate Student

Ataturk University

研究点 (2)

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