The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters in Patients Receiving Ventilator Support in Intensive Care
试验速览
- 阶段
- 不适用
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- Delirium
研究概览
简要总结
The purpose of this study is to test the effect of a twice daily, 60-minute, nurse initiated, music listening intervention on patients followed in the ICU with MV support as compared to patients who receive care as usual and ear plugs.
详细描述
Delirium is an acute disorder of consciousness and cognitive function that occurs frequently in critical care settings. Many critically ill patients (e.g., up to 80% of patients) experience ICU delirium due to underlying medical or surgical health problems, recent surgical or other invasive procedures, medications, or various noxious stimuli (e.g., underlying psychological stressors, mechanical ventilation [MV], noise, light, patient care interactions, and drug-induced sleep disruption or deprivation). Delirium contributes to adverse outcomes such as increased mortality and morbidity, longer length of ICU stays, prolonged MV, costlier hospitalizations, and cognitive impairment after hospital discharge. The Society of Critical Care Medicine (SCMM) Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU (PADIS) recommend non-pharmacological interventions of preventing delirium and other symptoms. Music, which is one of the non-pharmacological applications, is one of the cognitive-behavioral treatment methods applied in the field of ICU as in many other fields. Music is easy method to apply and has no side effects and contributes to physical, psychological, emotional and spiritual healing. In the literature, it is seen that music intervention studies applied to patients followed in the ICU mostly focus on the effects on anxiety, pain, non-invasive ventilation tolerance, and stress response (heart rate, blood pressure, respiratory rate). The relationship between intensive care delirium and all these symptoms (pain, agitation, anxiety, stress response, etc.) and their interaction with each other have been clarified in the light of evidence-based guidelines and studies. Therefore, the aim of this study is to examine the effects of music applied to patients followed in the ICU with MV support on delirium, pain, need for sedation, anxiety and vital parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years,
- •Admitted to the ICU as of the start of the study and planned to be followed up in the ICU for at least 24 hours,
- •Needing invasive MV for at least 24 hours,
- •Pre-deliric score > 20%
- •At least one positive delirium according to CAM-ICU,
- •GCS score > 8,
- •RASS score ≥ -3,
- •Hemodynamically stable,
- •CPOT score ≥ 3
排除标准
- •Hearing or vision problems,
- •Diagnosed with psychiatric illness,
- •Diagnosed with dementia,
- •Having acute neurological injury,
- •Alcohol/drug poisoning
- •Hemodynamically unstable and treated with high-dose inotropic/vasopressor medication,
- •Pregnant,
- •Planned to be followed in ICU for less than 24 hours,
- •Does not need MV,
- •GCS score ≤ 8,
- •RASS score < -3,
- •Patients referred from another ICU
结局指标
主要结局
Delirium
时间窗: Date of study enrollment through 12 months.
The delirium event assessed twice daily by trained research nurse using the CAM-ICU. The diagnosis of delirium is based on the presence of two major criteria (i.e. acute or fluctuating onset plus lack of attention) and at least one of the minor criteria (disorganized thinking or altered consciousness level).
次要结局
- Anxiety level(2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization)
- Systolic/diastolic blood pressure(2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization)
- Pain severity(2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization)
- Delirium severity(2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization)
- Need of sedation(2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization)
- Heart rate(2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization)
- Oxygen saturation(2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization)
- Respiratory rate(2 times daily, before, midst and after each intervention for up to 5 days while in the ICU post randomization)
研究者
Öznur ERBAY DALLI
Principal Investigator
Ege University