Auricular Acupuncture for Exam Anxiety in Medical Students

Study Overview
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Brief Summary
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Title of the study: Auricular acupuncture (AA) for pre-exam anxiety: A blinded randomized crossover study on healthy volunteers Study period: 04/2012 - 07/2012 Institution: Department of Anesthesiology and Intensive Care Medicine University Medicine of Greifswald Aim of the study: To investigate the anxiolytic effect of auricular acupuncture (AA) in comparison to placebo acupuncture and no intervention during oral exams in anatomy at the University of Greifswald Design: Prospective blinded randomized crossover trial Intervention: AA using indwelling fixed needles, retained 24 h in situ AA using placebo needles Number of volunteers: N = 40 Outcome measures: Anxiety level, Heart rate, blood pressure.

Official Title
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Auricular Acupuncture for Exam Anxiety in Medical Students: A Randomized Crossover Investigation

Conditions
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Anxiety

Intervention / Treatment
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* Device: Auricular acupuncture
* Device: Placebo acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medical students at the University of Greifswald Going to take part in oral exams of human anatomy Participants without previous anxiolytic medication Participants without any experiences with acupuncture Patients who have given written informed consent Exclusion Criteria: Local auricular skin infection Pregnant or lactating women Participants with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolapse (risk of bacterial endocarditis according to guidelines of AHA) Participants who are unable to understand the consent form History of psychiatric disease, alcohol and drug abuse

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Auricular acupuncture<br>Auricular acupuncture with indwelling fixed auricular acupuncture needles | Device: Auricular acupuncture<br>* Auricular acupuncture with indwelling permanent needles<br>|
| Placebo Comparator: Placebo acupuncture<br>Placebo acupuncture with placebo fixed needles | Device: Placebo acupuncture<br>* Placebo acupuncture with placebo needles<br>|
| No Intervention: Standard therapy<br>No intervention, just observation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of anxiety | State-Trait-Anxiety Inventory | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate |  | 1 day | 
| blood pressure |  | 1 day |