Anxiety Clinical Trial
— AA_EW_AnxiOfficial title:
Auricular Acupuncture (AA) vs. Expressive Writing in Treatment of Pre-exam Anxiety - Randomised Crossover Study in Medical Students
| Verified date | March 2017 |
| Source | University Medicine Greifswald |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Title of the study: Auricular acupuncture (AA) vs. expressive writing for pre-exam anxiety -
a randomised crossover study
Study period: 04 / 2014 - 07 / 2014
Principal Investigator: Prof. Dr. T. Usichenko Department of Anaesthesiology and Intensive
Care Medicine University Medicine of Greifswald
Aim of the study: To investigate the anxiolytic effect of AA vs. expressive writing and vs.
no intervention in students, passing the oral exams in anatomy at the University of
Greifswald
Design: Prospective randomised crossover trial
Interventions: 1. AA using indwelling fixed needles, retained 24 h in situ 2. Expressive
writing
Number of volunteers: N = 40
Healthy medical students at the University of Greifswald Participants of the anatomy exams
in spring/summer 2014 Without previous anxiolytic, sedative and analgesic medication No
pregnancy or lactating Informed consent
Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase
| Status | Completed |
| Enrollment | 37 |
| Est. completion date | July 2014 |
| Est. primary completion date | July 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years to 35 Years |
| Eligibility |
Inclusion Criteria: 1. Medical students at the University of Greifswald 2. Going to take part in oral exams of human anatomy 3. Participants without previous anxiolytic medication 4. Ability to express the thoughts and emotions ("expressive writing") 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, intracardiac and intravascular shunts, hypertrophic cardiomyopathy 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University Medicine Greifswald |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Intensity of anxiety | State-trait-Anxiety Inventory | 2 days | |
| Secondary | salivary alpha-amylase | enzymatic activity of salivary alpha-amylase | 1 day | |
| Secondary | heart rate | heart rate | 1 day | |
| Secondary | blood pressure | blood pressure | 1 day |
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