NL-OMON22786尚未招募不适用
MusiC to prevent deliriUm during neuroSurgerY (MUSYC): A Single Centered Prospective Randomized Controlled Trial
Erasmus MC Doelmatigheid 20190 个研究点目标入组 189 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 189
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients undergoing a craniotomy.
- •2. Adult patients (cq age =18 years)
- •3. Sufficient knowledge of the Dutch language to understand the study documents in the judgement of the attending physician or researcher.
- •4. Provision of written informed consent by patient or legal representative.
排除标准
- •1. Impaired awareness before surgery (i.e. GCS < M6).
- •2. Planned post-operative ICU admission.
- •3. Suspected delirium (defined as fluctuating awareness).
- •4. Current antipsychotic treatment.
- •5. Patients undergoing interventions impeding supply of music (e.g. surgical translabyrinthine approach, awake surgery).
- •6. Severe bilateral hearing impairment, defined as no verbal communication possible.
- •7. Current participation in other clinical trials interfering with results.
研究者
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