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临床试验/NCT06442644
NCT06442644尚未招募不适用

Live Music in the Intensive Care Unit

Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
202
试验地点
2
主要终点
Heartrate variability

研究概览

简要总结

The goal of this quasi-experimental pre- post test study is to test a patient-tailored live music intervention's effect on stress and pain reduction in adult, critically ill patients admitted to the intensive care unit.

The main question it aims to answer is:

• Does live music reduce stress and pain in adult intensive care patients?

In the pre-post test design, the patients will be their own control. There will be no randomisation. Researchers will compare measurements of heartrate, respiration rate, heartrate variability, blood pressure and pain before and after the live music intervention to see if live music effects these vital parameters.

Participants will listen to live music in their room in the intensive care unit for 5 to 15 minutes.

详细描述

  1. Introduction The intensive care unit (ICU) has been and is still undergoing paradigmatic changes and technological advancements, meaning that an increased number of patients are conscious during their ICU stay and more survive to remember their ICU admission. Patients are admitted to the ICU because they are in urgent need of life saving treatments. However, an ICU admission can be a traumatic experience for patients and their relatives. The ICU patient room is designed with the purpose of promoting advanced care and treatment performed by the healthcare professionals. However, the room leaves little space for positive sensory inputs for the patients and the relatives; rather the environment is a highly technological, noisy, unfamiliar and often frightening experience for the patients and their relatives - memories of this may follow them for years. In this project, the investigators aim to test patient-tailored live music as an intervention to reduce stress and pain for adult ICU patients.
  2. Project aim The aim of this study is to test a patient-tailored live music intervention's effect on stress reduction in adult, critically ill patients admitted to the intensive care unit.
  3. Design and analysis method The study is a quasi-experimental pre- post test study, with patients being their own control. The pre-post test measurements will be carried out at predefined time points (5 minutes before and 5 minutes after the intervention). Our primary outcome, the HRV, will be measured continuously 5 minutes before the music intervention, during the whole intervention and 5 minutes after the intervention. There will be no randomisation.

Relevant static calculations will be performed using Stata. Statistical analysis will be supported by a statistician at CONNECT (A data support centre for clinical and genomic data). 4. Music intervention This study will be performed in collaboration with the Royal Academy of Music, Aarhus, Denmark (RAMA) and ICU departments across Central Denmark Region, Aarhus University Hospital being main investigator.

The musicians have participated in a training programme after which they are able to carry out one-on-one patient-tailored music sessions for adult patients at the ICU carried out in the patient's room.

Each music intervention comprises three components: 1) A prior briefing by the nurse on the patients' condition relevant for the musical practice 2) A patient-tailored live music session in the patient room and 3) A debriefing with the nurse.

The musicians plan a programme for each intervention day, and the patients will therefore not have the opportunity to choose specific pieces of music. The musicians prepare a mix of relaxing, soothing, familiar and unknown music with low-pitched instruments, e.g., guitar and piano, in a slow tempo (60-80 beats per minute), with a predictable musical structure, rhythm, and tonality, as it has been shown that low-pitched and low-intensity music may be calming and may regulate arousal levels. The length of the music intervention will range from 5 to 15 minutes depending on how many music pieces the patient wants to listen to or based on the nurse's assessment of the patient's condition. 5. Sample size Aarhus University Hospital is the main research centre, but the study is a multi-centre study with participation of the Regional Hospitals of Gødstrup, Horsens and Viborg; all have agreed to participate. The intervention is fully implemented at all hospitals.

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

  • Adults (>18 years)
  • Admitted to one of the four participating ICU departments for a minimum of 24 hours
  • Able to read and speak Danish
  • For incapable patients, it is necessary to have a close relative (e.g., spouse or adult child), as these will provide proxy consent for study participation

排除标准

  • Unstable patients with a need of change/adjustment of the ongoing treatment of e.g. drug infusions or ventilator settings during the music intervention, as this can possibly affect the HRV measurements.

结局指标

主要结局

Heartrate variability

时间窗: baseline (10 minutes before listening to live music), during (5-15 minutes of listening to live music), after (10 minutes after listening to live music)

measured via the HeartMath Sensor, which is validated for measuring stress levels

次要结局

  • The patient's subjective pain experience via a numerical ranking scale (NRS)(baseline (5 minutes before listening to live music), after (5 minutes after listening to live music))
  • Blood pressure(baseline (5 minutes before listening to live music), after (5 minutes after listening to live music))
  • Patient's self-reported stress level measured by STAI (State-Trait Anxiety Inventory) a validated short version to measure the stress level.(baseline (5 minutes before listening to live music), after (5 minutes after listening to live music))
  • Heartrate(baseline (5 minutes before listening to live music), after (5 minutes after listening to live music))
  • Respiration rate(baseline (5 minutes before listening to live music), after (5 minutes after listening to live music))

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Linette Thorn

Specialized intensive care nurse

Aarhus University Hospital

研究点 (2)

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