Auricular Acupuncture for Exam Anxiety in Medical Students (AAAnx)
Primary Purpose
Anxiety
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Auricular acupuncture
Placebo acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
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
Sites / Locations
- University Medicine of Greifswald
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Auricular acupuncture
Placebo acupuncture
Standard therapy
Arm Description
Auricular acupuncture with indwelling fixed auricular acupuncture needles
Placebo acupuncture with placebo fixed "needles"
No intervention, just observation
Outcomes
Primary Outcome Measures
Intensity of anxiety
State-Trait-Anxiety Inventory
Secondary Outcome Measures
heart rate
blood pressure
Full Information
NCT ID
NCT02920164
First Posted
September 28, 2016
Last Updated
September 29, 2016
Sponsor
University Medicine Greifswald
1. Study Identification
Unique Protocol Identification Number
NCT02920164
Brief Title
Auricular Acupuncture for Exam Anxiety in Medical Students
Acronym
AAAnx
Official Title
Auricular Acupuncture for Exam Anxiety in Medical Students: A Randomized Crossover Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auricular acupuncture
Arm Type
Active Comparator
Arm Description
Auricular acupuncture with indwelling fixed auricular acupuncture needles
Arm Title
Placebo acupuncture
Arm Type
Placebo Comparator
Arm Description
Placebo acupuncture with placebo fixed "needles"
Arm Title
Standard therapy
Arm Type
No Intervention
Arm Description
No intervention, just observation
Intervention Type
Device
Intervention Name(s)
Auricular acupuncture
Intervention Description
Auricular acupuncture with indwelling permanent needles
Intervention Type
Device
Intervention Name(s)
Placebo acupuncture
Intervention Description
Placebo acupuncture with placebo needles
Primary Outcome Measure Information:
Title
Intensity of anxiety
Description
State-Trait-Anxiety Inventory
Time Frame
2 days
Secondary Outcome Measure Information:
Title
heart rate
Time Frame
1 day
Title
blood pressure
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taras Usichenko, MD, PhD
Organizational Affiliation
University Medicine of Greifswald
Official's Role
Study Chair
Facility Information:
Facility Name
University Medicine of Greifswald
City
Greifswald
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Auricular Acupuncture for Exam Anxiety in Medical Students
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