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临床试验/NCT03948984
NCT03948984已完成不适用

Assessing the Impact of LIve Music in the Intensive Care Unit (ICU) to Improve Care for Critically Ill Patients: A Pilot, Prospective, Single-center Study of Therapeutic Music

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2022年5月31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
111
试验地点
2
主要终点
Change in perceived relaxation visual analog scale

研究概览

简要总结

Noise in the ICU can worsen patient outcomes through factors such as increased cardiovascular stress, alteration in sleep, and increased discomfort or pain The purpose of this study is to determine the benefit of therapeutic music in the ICU on patients, their families, and ICU staff.

详细描述

Noise in the ICU can worsen patient outcomes through factors such as increased cardiovascular stress, alteration in sleep, and increased discomfort or pain. The purpose of this study is to determine the benefit of therapeutic music in the ICU on patients, their families, and ICU staff. The results of this study will inform clinicians on best practices for redesigning, implementing and evaluating a patient and family focused therapeutic music program in the ICU.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Current hospitalization in adult ICU at Vanderbilt University Medical Center

排除标准

  • Airborne or special contact isolation
  • Unstable hypotension or bradycardia
  • Pregnancy
  • Current prisoner status
  • The inability to communicate either verbally or in writing in English to complete the therapeutic music evaluations
  • Refusal to participate
  • Family Member Inclusion Criteria
  • Family member of ICU patient
  • Family Member Exclusion Criteria
  • The inability to communicate either verbally or in writing English to complete the therapeutic music evaluations
  • Refusal to participate
  • ICU Clinical Staff Inclusion Criteria
  • ICU clinical staff who are in the patient's room during the music session
  • ICU Clinical Staff Exclusion Criteria
  • Refusal to participate

结局指标

主要结局

Change in perceived relaxation visual analog scale

时间窗: Immediately before and after therapeutic music session (about 20 minutes long)

Comparison of patient reported perceived relaxation visual analog score using an 11-point numerical rating scale ranging from 0 (not relaxed at all) to 10 (completely relaxed).

Change in perceived anxiety visual analog score

时间窗: Immediately before and after therapeutic music session (about 20 minutes long)

Comparison of patient reported perceived anxiety visual analog score using an 11-point numerical rating scale ranging from 0 (no anxiety) to 10 (worst possible anxiety).

Change in perceived pain visual analog score

时间窗: Immediately before and after therapeutic music session (about 20 minutes long)

Comparison of patient reported perceived pain visual analog score using an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).

次要结局

  • Acceptability of Intervention Measure (AIM)(After conclusion of therapeutic music session (about 20 minutes))
  • Intervention Appropriateness Measure (IAM)(After conclusion of therapeutic music session (about 20 minutes))
  • Feasibility of Intervention (FIM)(After conclusion of therapeutic music session (about 20 minutes))
  • Patient Perceived Impact(After conclusion of therapeutic music session (about 20 minutes))
  • Perceived Barriers(After conclusion of therapeutic music session (about 20 minutes))

研究者

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

Joseph Schlesinger

Assistant Professor of Anesthesiology

Vanderbilt University Medical Center

研究点 (2)

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