Auricular Stimulation vs. Relaxation for Pre-exam Anxiety

Study Overview
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Brief Summary
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Title of the study: Auricular acupuncture (AA) vs. progressive muscle relaxation for pre-exam anxiety - a randomised crossover study Study period: 04 / 2015 - 07 / 2015 Principal Investigator: PD Dr. T. Usichenko Department of Anaesthesiology and Intensive Care, University Medicine of Greifswald Aim of the study: To investigate the anxiolytic effect of AA vs. progressive muscle relaxation 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. Progressive muscle relaxation Number of volunteers: N = 30 Healthy medical students at the University of Greifswald Participants of the oral anatomy exams in spring/summer 2015 Without previous anxiolytic, sedative and analgesic medication No pregnancy or lactating Informed consent Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase

Official Title
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Auricular Acupuncture vs. Progressive Muscle Relaxation in Treatment of Pre-exam Anxiety - Randomised Crossover Study in Medical Students

Conditions
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Anxiety

Intervention / Treatment
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* Device: Auricular stimulation
* Behavioral: Relaxation


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 Ability to understand and perform PMR Written informed consent Exclusion Criteria: Recidivist alcoholics Local auricular skin infection Pregnant or lactating women 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) Participants who are unable to understand the consent form History of psychiatric disease

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 |
| --- | --- |
| Experimental: Auricular stimulation<br>Auricular stimulation using indwelling auricular acupuncture needles | Device: Auricular stimulation<br>* Auricular stimulation with indwelling fixed needles<br>|
| Experimental: Muscle relaxation<br>Progressive muscle relaxation according to Jacobsen | Behavioral: Relaxation<br>* Progressive muscle relaxation<br>|
| No Intervention: No intervention<br>No intervention, just monitoring of outcome parameters | |

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 |
| --- | --- | --- |
| Salivary alpha-amylase | Enzymatic activity of salivary alpha-amylase | 1 day | 
| heart rate | heart rate | 1 day | 
| blood pressure | blood pressure | 1 day |