Auricular Stimulation for Relief of Stress and Anxiety

NCT04703907 | Unknown

• 1 other identifier: BB 324/20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress and Anxiety

Outcome Measures

Primary Outcomes (1)

• Anxiety

  State anxiety

  15 weeks of investigation

Secondary Outcomes (2)

• Trait anxiety

  Before and after 15 weeks of intervention application

• Sleep quality

  15 weeks of investigation

Study Arms (2)

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

Auricular stimulation OTHER

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

Intervention group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

University Medicine of Greifswald

Greifswald, 17475, Germany

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 11, 2021
• Study Start: December 3, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)