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临床试验/NCT05533112
NCT05533112招募中不适用

Binaural Beat Stimulation as a Cost-effective Tool to Reduce Preoperative Anxiety and Improve Postoperative Outcome After General Anesthesia

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年11月10日最近更新:
适应症

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

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)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (2)

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