Auricular Stimulation for Relief of Stress and Anxiety

NCT ID: NCT04703907

Last Updated: 2021-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-03

Study Completion Date

2021-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stress and Anxiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Auricular stimulation

Intervention Type OTHER

Auricular "acupuncture-like" stimulation (percutaneous sensory stimulation of cranial nerves)

Waiting list

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Auricular stimulation

Auricular "acupuncture-like" stimulation (percutaneous sensory stimulation of cranial nerves)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medicine of Greifswald

Greifswald, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Taras Usichenko, MD, PhD

Role: primary

+49 (0) 383486 ext. 5893

Other Identifiers

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BB 324/20

Identifier Type: -

Identifier Source: org_study_id

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