Stress and Anxiety Clinical Trial
— AA_COVIDOfficial title:
Auricular Stimulation (AS) vs. "Waiting List" for Relief of Stress and Anxiety in Health Care Workers During COVID-19 Pandemic - a Prospective Controlled Investigation
| NCT number | NCT04703907 |
| Other study ID # | BB 324/20 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 3, 2020 |
| Est. completion date | August 2021 |
| Verified date | January 2021 |
| Source | University Medicine Greifswald |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 60 |
| Est. completion date | August 2021 |
| Est. primary completion date | August 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 65 Years |
| Eligibility | Inclusion Criteria: 1. Medical care workers at the University Medicine of Greifswald 2. Experiencing stress and anxiety in connection with COVID-19 pandemic 3. Participants without previous anxiolytic medication 4. Ability to understand and fill in the structured questionnaire (Appendix D & E) 5. Written informed consent Exclusion Criteria: 1. Recidivist alcoholics 2. Local auricular skin infection 3. Pregnant or lactating women 4. Participants with prosthetic or damaged cardiac valves and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA) 5. Participants who are unable to understand the consent form 6. History of psychiatric disease |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Medicine of Greifswald | Greifswald |
| Lead Sponsor | Collaborator |
|---|---|
| University Medicine Greifswald |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Anxiety | State anxiety | 15 weeks of investigation | |
| Secondary | Trait anxiety | Before and after 15 weeks of intervention application | ||
| Secondary | Sleep quality | 15 weeks of investigation |