Auricular Stimulation for Relief of Stress and Anxiety During COVID-19 Epidemic (AA_COVID_19)

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

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.

Study Overview

• Status: Completed
• Conditions: Stress and Anxiety
• Intervention / Treatment: Other: Auricular stimulation

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany, 17475
    • University Medicine of Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; This group is constituted from patients who will receive the intervention first within 15 weeks	Other: Auricular stimulation; Auricular "acupuncture-like" stimulation (percutaneous sensory stimulation of cranial nerves)
No Intervention: Waiting list; This group is constituted from patients who will receive the intervention after 15 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	State anxiety	15 weeks of investigation

Secondary Outcome Measures

Outcome Measure	Time Frame
Trait anxiety	Before and after 15 weeks of intervention application
Sleep quality	15 weeks of investigation

Collaborators and Investigators

• Sponsor: University Medicine Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: BB 324/20 (Other Identifier: Ethics Commission of the University Medicine of Greifswald)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No