Auricular Acupuncture for Exam Anxiety in Medical Students (AAAnx)

September 29, 2016 updated by: University Medicine Greifswald

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Greifswald, Germany
        • University Medicine of Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Auricular acupuncture
Auricular acupuncture with indwelling fixed auricular acupuncture needles
Device: Auricular acupuncture
Auricular acupuncture with indwelling permanent needles
Placebo Comparator: Placebo acupuncture
Placebo acupuncture with placebo fixed "needles"
Device: Placebo acupuncture
Placebo acupuncture with placebo needles
No Intervention: Standard therapy
No intervention, just observation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
heart rate
Time Frame: 1 day
1 day
blood pressure
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medicine Greifswald

Investigators

  • Study Chair: Taras Usichenko, MD, PhD, University Medicine of Greifswald

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimate)

September 30, 2016

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB 49/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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