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Auricular Stimulation for Relief of Stress and Anxiety (AA_COVID)

Primary Purpose

Stress and Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Auricular stimulation
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress and Anxiety

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medicine of GreifswaldRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Waiting list

Arm Description

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

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

Outcomes

Primary Outcome Measures

Anxiety
State anxiety

Secondary Outcome Measures

Trait anxiety
Sleep quality

Full Information

First Posted
January 8, 2021
Last Updated
January 8, 2021
Sponsor
University Medicine Greifswald
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1. Study Identification

Unique Protocol Identification Number
NCT04703907
Brief Title
Auricular Stimulation for Relief of Stress and Anxiety
Acronym
AA_COVID
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress and Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
This group is constituted from patients who will receive the intervention first within 15 weeks
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
This group is constituted from patients who will receive the intervention after 15 weeks
Intervention Type
Other
Intervention Name(s)
Auricular stimulation
Intervention Description
Auricular "acupuncture-like" stimulation (percutaneous sensory stimulation of cranial nerves)
Primary Outcome Measure Information:
Title
Anxiety
Description
State anxiety
Time Frame
15 weeks of investigation
Secondary Outcome Measure Information:
Title
Trait anxiety
Time Frame
Before and after 15 weeks of intervention application
Title
Sleep quality
Time Frame
15 weeks of investigation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
University Medicine of Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taras Usichenko, MD, PhD
Phone
+49 (0) 383486
Ext
5893
Email
taras@uni-greifswald.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Auricular Stimulation for Relief of Stress and Anxiety

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