Auricular Acupuncture for Exam Anxiety in Medical Students

Anxiety Clinical Trial

— AAAnx  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920164
• Other study ID #: BB 49/12
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2016
• Last updated: September 29, 2016
• Start date: April 2012
• Est. completion date: July 2012

Study information

• Verified date: September 2016
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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:

1. AA using indwelling fixed needles, retained 24 h in situ

2. AA using placebo needles

Number of volunteers: N = 40

Outcome measures: Anxiety level, Heart rate, blood pressure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• 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. Participants without any experiences with acupuncture

5. Patients who have given written informed consent

Exclusion Criteria:

1. Local auricular skin infection

2. Pregnant or lactating women

3. 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)

4. Participants who are unable to understand the consent form

5. History of psychiatric disease, alcohol and drug abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• Auricular acupuncture
Auricular acupuncture with indwelling permanent needles
• Placebo acupuncture
Placebo acupuncture with placebo needles

Locations

Country	Name	City	State
Germany	University Medicine of Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of anxiety	State-Trait-Anxiety Inventory	2 days	No
Secondary	heart rate		1 day	No
Secondary	blood pressure		1 day	No