Result of a Music Intervention on Anxiety in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 6
- 主要终点
- Anxiety (VAS-A)
研究概览
简要总结
Rationale: Anxiety is common in critically ill patients, and has likely become more prevalent in the recent decade due to the imperative of the recent PADIS guidelines to use low levels of sedation and strive for wakefulness. Administration of sedative and analgesic medication is often chosen to reduce anxiety, especially when associated with agitation, but especially sedatives are associated with prolonged mechanical ventilation, delirium and muscle wasting and are therefore preferably minimized. Previous studies have suggested positive effects of music interventions on anxiety in the critically ill, next to other physiological signs such as pain. However, management of anxiety has not been included in the PADIS guidelines, and there is lack of evidence to treat it in spite of its growing importance. Therefore, we aim to study the effect of music intervention on anxiety in adult critically ill patients.
Objective: The primary objective is to assess the effect of music intervention on the level of anxiety.
Study design: A randomized controlled trial. Study population: Adult patients admitted to the intensive care unit, with whom communication is possible (Richmond Agitation Sedation Scale of -2 or higher).
Intervention (if applicable): The music group will be offered to listen to music two times per day for three days after inclusion, during 30-60 minutes per session. Chosen music will be based on the preference of the patient. The control group will receive standard of care during the entire study.
Main study parameters/endpoints: The primary outcome is the effect of music on the Visual Analogue Scale for anxiety (VAS-A). Secondary outcomes include effect of music on sedation and agitation level, medication requirement, pain, sleep, delirium, heart rate, mean arterial pressure, and ICU memory and experience.
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
- 否
入选标准
- •Patient is hemodynamically stable and communicable (RASS of -2 or higher in the 24h before intended inclusion: meaning patient is at least briefly awakened with eye contact to voice).
- •Expected ICU stay upon randomisation of at least another 48 hours.
- •Written informed consent acquired from the patient or legal representative.
排除标准
- •Patients with severe hearing impairment, defined as no verbal communication possible.
- •Neurological condition (e.g. severe stroke), when deemed to interfere with processing of music (e.g. not applicable to patients with minor stroke in past medical history without significant residual neurological deficits; those patients could be included).
- •Insufficient knowledge of the Dutch or English language for informed consent.
- •Participation in another study that may possibly intervene with the primary outcome measure
结局指标
主要结局
Anxiety (VAS-A)
时间窗: 1.5 year
Measured using the Visual Analogue Scale for Anxiety (VAS-A), on a scale of 0 to 10, in which a higher score means a worse outcome.
次要结局
- Agitation and sedation level(1.5 year)
- Complications(1.5 year)
- Anxiety (STAI-6)(1.5 year)
- Sedative and opioid medication requirement(1.5 year)
- Mean Arterial Pressure (MAP)(1.5 year)
- Sleep quality(1.5 year)
- Delirium(1 year)
- ICU memory and experience(1.5 year)
- Heart Rate (HR)(1.5 year)
- Level of Pain(1.5 year)
研究者
Mathieu van der Jagt
Principal Investigator
Erasmus Medical Center