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临床试验/NCT04703907
NCT04703907已完成不适用

Auricular Stimulation (AS) vs. "Waiting List" for Relief of Stress and Anxiety in Health Care Workers During COVID-19 Pandemic - a Prospective Controlled Investigation

University Medicine Greifswald2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年12月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
2
主要终点
Anxiety

研究概览

简要总结

The aim of the study is to evaluate whether auricular stimulation (percutaneous sensory stimulation of cranial nerves) as compared vs. no intervention (waiting list) reduces stress and anxiety in health care providers, working at the time of COVID-19 pandemic at the University Medicine of Greifswald.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medical care workers at the University Medicine of Greifswald
  • Experiencing stress and anxiety in connection with COVID-19 pandemic
  • Participants without previous anxiolytic medication
  • Ability to understand and fill in the structured questionnaire (Appendix D & E)
  • Written informed consent

排除标准

  • Recidivist alcoholics
  • Local auricular skin infection
  • Pregnant or lactating women
  • Participants with prosthetic or damaged cardiac valves and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA)
  • Participants who are unable to understand the consent form
  • History of psychiatric disease

研究组 & 干预措施

Intervention group

Experimental

This group is constituted from patients who will receive the intervention first within 15 weeks

干预措施: Auricular stimulation (Other)

Waiting list

No Intervention

This group is constituted from patients who will receive the intervention after 15 weeks

结局指标

主要结局

Anxiety

时间窗: 15 weeks of investigation

State anxiety

次要结局

  • Trait anxiety(Before and after 15 weeks of intervention application)
  • Sleep quality(15 weeks of investigation)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (2)

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