Stress and AnxietyAA_COVID_19NCT04703907
Auricular Stimulation for Relief of Stress and Anxiety During COVID-19 Epidemic
A study testing Auricular stimulation in people with Stress and Anxiety, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Stress and Anxiety
- What is being tested?
- Auricular stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteGermany
- Study dates
- 3 Dec 2020to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Stress and Anxiety
- Being tested
- Auricular stimulation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular stimulationOther
Auricular "acupuncture-like" stimulation (percutaneous sensory stimulation of cranial nerves)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group is constituted from patients who will receive the intervention first within 15 weeks Receives: Other: Auricular stimulation |
| Waiting list | No intervention | This group is constituted from patients who will receive the intervention after 15 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
State anxiety
Measured: 15 weeks of investigation
Secondary outcomes (2)
Trait anxiety
Measured: Before and after 15 weeks of intervention application
Sleep quality
Measured: 15 weeks of investigation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start3 Dec 2020
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress and AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Prospective investigation during 15 weeks of treatment for each participant with "waiting list" control group (no intervention). Waiting group will receive the intervention (auricular stimulation) after 15 weeks of investigation.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703907
- Sponsor's protocol ID
- BB 324/20
- Other IDs
- BB 324/20
- Acronym
- AA_COVID_19
- Status last verified
- Jun 2026
- First submitted
- 8 Jan 2021
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04703907
- Acronym / sponsor ID
- AA_COVID_19 / BB 324/20
- Conditions
- Stress and Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 3 Dec 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective investigation during 15 weeks of treatment for each participant with "waiting list" control group (no intervention). Waiting group will receive the intervention (auricular stimulation) after 15 weeks of investigation.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Auricular stimulationThis group is constituted from patients who will receive the intervention first within 15 weeks |
| Waiting list | No intervention | –This group is constituted from patients who will receive the intervention after 15 weeks |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular stimulationAuricular "acupuncture-like" stimulation (percutaneous sensory stimulation of cranial nerves) | Other | Intervention group |
Primary outcome
Anxiety
Time frame: 15 weeks of investigation
State anxiety
2 secondary outcomes
Trait anxiety
Time frame: Before and after 15 weeks of intervention application
Sleep quality
Time frame: 15 weeks of investigation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular stimulation in people with Stress and Anxiety, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 15 weeks of investigation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.