MusiC to Prevent deliriUm During neuroSurgerY: A Single Centered Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Delirium
研究概览
简要总结
Rationale: Delirium is a common and severe complication after neurosurgical procedures. Music before, during and after surgical procedures has proven its effectiveness in reducing pain, anxiety, stress and opioid medication in surgical patients. These symptoms belong to the main eliciting factors for developing delirium. Effective preventive therapy for delirium is not available. The investigators hypothesize that music listening, being a sustainable intervention with negligible risk of side effects, can lower delirium incidence among neurosurgical patients, resulting in reduction of in-hospital stays, healthcare costs and post-operative morbidity and mortality.
Objective: To assess the effect of peri-operative music on post-operative delirium in patients undergoing a craniotomy.
Study design: Single-centre prospective randomized controlled trial.
Study population: Adult patients undergoing a craniotomy at the Erasmus MC in Rotterdam.
Intervention: Recorded music, with headphones or earphones, before, during and after surgery.
Main study parameters/endpoints: Diagnosis of post-operative delirium screened by the DOS score confirmed by the consultant psychiatrist following the DSM-V criteria.
详细描述
Rationale:
Delirium is a common and severe complication after neurosurgical procedures. Music before, during and after surgical procedures has proven its effectiveness in reducing pain, anxiety, stress and opioid medication in surgical patients. These symptoms belong to the main eliciting factors for developing delirium. Effective preventive therapy for delirium is not available. The investigators hypothesize that music listening, being a sustainable intervention with negligible risk of side effects, can lower delirium incidence among neurosurgical patients, resulting in reduction of in-hospital stays, healthcare costs and post-operative morbidity and mortality.
Objective:
To assess the effect of peri-operative music on post-operative delirium in patients undergoing a craniotomy.
Hypothesis effect and sample size:
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
- None
盲法说明
Music vs. standard clinical care. No blinding of treatment was conducted.
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
- •Patients undergoing a craniotomy.
- •Adult patients (cq age ≥18 years)
- •Sufficient knowledge of the Dutch language to understand the study documents in the judgement of the attending physician or researcher.
- •Provision of written informed consent by patient or legal representative.
排除标准
- •Impaired awareness before surgery (i.e. GCS < M6).
- •Planned post-operative ICU admission.
- •Suspected delirium (defined as fluctuating awareness).
- •Current antipsychotic treatment
- •Patients undergoing interventions impeding supply of music (e.g. surgical translabyrinthine approach, awake surgery).
- •Severe bilateral hearing impairment, defined as no verbal communication possible.
- •Current participation in other clinical trials interfering with results.
结局指标
主要结局
Delirium
时间窗: First five post-operative days. In case of discharge within 5 days towards home without delirium, it will be considered as no delirium.
All participating patients on the ward will be screened using the Delirium Observation Screening (DOS) scale. The DOS is a score of 1 until 13, in which a score of 3 or higher is suspicious for delirium. Screening is conducted 3 times per day (i.e. during each shift) and maintained until day 5. In case of raised suspicion of delirium by DOS, a psychiatrist is consulted to confirm or reject clinical diagnosis of delirium based on the DSM-V criteria. Presence of delirium is confirmed by the psychiatrist after positive DOS screening, all other patients will be considered as absence of delirium. In case of discharge towards another hospital within 5 days, onset of delirium is evaluated in that hospital. In case of discharge within 5 days towards home without delirium, it will be considered as no delirium.
次要结局
- Severity and duration of delirium.(First five days or discharge. In case of positive delirium until it has 'faded out'.)
研究者
A.J.P.E. VIncent
Principal Investigator
Erasmus Medical Center