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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
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

19 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

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

First Posted
September 28, 2016
Last Updated
September 29, 2016
Sponsor
University Medicine Greifswald
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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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