Auricular Stimulation vs. Relaxation for Pre-exam Anxiety

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: Relaxation; Device: Auricular stimulation

• Registration Number: NCT03093571
• Lead Sponsor: University Medicine Greifswald

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2017-03
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Last Update Submitted: 2017-03-27
• Study First Posted: 2017-03-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 understand and perform PMR
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Muscle relaxation	Relaxation	Progressive muscle relaxation according to Jacobsen
Auricular stimulation	Auricular stimulation	Auricular stimulation using indwelling auricular acupuncture needles

Primary Outcome Measures

Name	Time	Method
Intensity of anxiety	2 days	State-trait-anxiety-inventory

Secondary Outcome Measures

Name	Time	Method
Salivary alpha-amylase	1 day	Enzymatic activity of salivary alpha-amylase
heart rate	1 day	heart rate
blood pressure	1 day	blood pressure