Auricular Stimulation for Relief of Stress and Anxiety Du... | NCT04703907

Studies
Auricular Stimulation for Relief of Stress and Anxiety During COVID-19 Epidemic

NCT04703907

Sponsor

University Medicine Greifswald

Status

Completed

Last Update Posted

Jun 11, 2026Actual

Enrollment

62Actual

Phase

Not Applicable

Conditions

Stress and Anxiety

Interventions

Auricular stimulation

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
BB 324/20	Other Identifier	Ethics Commission of the University Medicine of Greifswald

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 3, 2020Actual

Primary Completion Date

Aug 30, 2021Actual

Completion Date

Aug 30, 2021Actual

First Submitted Date

Jan 8, 2021

First Submission Date that Met QC Criteria

Jan 8, 2021

First Posted Date

Jan 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2026

Last Update Posted Date

Jun 11, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	This group is constituted from patients who will receive the intervention first within 15 weeks	Other: Auricular stimulation
Waiting list	No Intervention	This group is constituted from patients who will receive the intervention after 15 weeks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Auricular stimulation	Other	Auricular "acupuncture-like" stimulation (percutaneous sensory stimulation of cranial nerves)	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anxiety	State anxiety	15 weeks of investigation

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medicine of Greifswald		Greifswald		17475	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention 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.