Binaural Beat Stimulation as a Cost-effective Tool to Reduce Preoperative Anxiety and Improve Postoperative Outcome After General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Reduction of preoperative anxiety
研究概览
简要总结
We plan to evaluate the potential of binaural beat stimulation as a cost-effective tool to improve perioperative patient outcome. Preoperative anxiety and postoperative neurocognitive disorders are two major issues patients have to deal with in the perioperative period. In this context, preoperative stress and anxiety are independent risk factors for postoperative neurocognitive disorders. The primary goal of our proposed study therefore is to reduce preoperative anxiety by stimulating patients with binaural beats. As binaural beats might also entrain brainwaves, the secondary goal of the study is to investigate whether binaural beats can induce alpha oscillatory activity during emergence from anesthesia. This type of oscillation has been demonstrated to be protective for postoperative neurocognitive disorders and might therefore complement the effects of preoperative anxiety reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Fluent in German (Munich) or Portuguese (Porto)
- •Scheduled for elective minor or intermediate risk procedure
排除标准
- •ASA status 4
- •History of drug abuse
- •Pre-existing neurocognitive or psychiatric disorders
- •Auditory Impairments, vision diseases or other diagnosed cognitive impairments
结局指标
主要结局
Reduction of preoperative anxiety
时间窗: Assessments will take place one day before surgery as well as before administration of the intervention
Binaural beat stimulation before surgery can reduce preoperative anxiety
次要结局
- Lower incidence of perioperative neurocognitive disorders(Incidence of perioperative neurocognitive disorders will be assessed during the patients stay in the PACU as well as one day post surgery)
- Increase of EEG alpha-band power during anesthesia emergence(Analysis will include the last 20 minutes of surgical procedure until patients are responsive again)
