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Auricular Stimulation vs. Expressive Writing for Exam Anxiety (AA_EW_Anxi)

Primary Purpose

Anxiety

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auricular acupuncture
Expressive writing
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. Ability to express the thoughts and emotions ("expressive writing")
  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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    No Intervention

    Arm Label

    Auricular stimulation

    Expressive writing

    No intervention

    Arm Description

    Auricular acupuncture with indwelling fixed auricular acupuncture needles

    Expressive writing - sharing the emotional expectations in front of forthcoming exam

    No intervention, just observation and monitoring of outcome measures

    Outcomes

    Primary Outcome Measures

    Intensity of anxiety
    State-trait-Anxiety Inventory

    Secondary Outcome Measures

    salivary alpha-amylase
    enzymatic activity of salivary alpha-amylase
    heart rate
    heart rate
    blood pressure
    blood pressure

    Full Information

    First Posted
    March 23, 2017
    Last Updated
    March 27, 2017
    Sponsor
    University Medicine Greifswald
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03093584
    Brief Title
    Auricular Stimulation vs. Expressive Writing for Exam Anxiety
    Acronym
    AA_EW_Anxi
    Official Title
    Auricular Acupuncture (AA) vs. Expressive Writing in Treatment of Pre-exam Anxiety - Randomised Crossover Study in Medical Students
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (Actual)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Medicine Greifswald

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Title of the study: Auricular acupuncture (AA) vs. expressive writing for pre-exam anxiety - a randomised crossover study Study period: 04 / 2014 - 07 / 2014 Principal Investigator: Prof. Dr. T. Usichenko Department of Anaesthesiology and Intensive Care Medicine University Medicine of Greifswald Aim of the study: To investigate the anxiolytic effect of AA vs. expressive writing 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. Expressive writing Number of volunteers: N = 40 Healthy medical students at the University of Greifswald Participants of the anatomy exams in spring/summer 2014 Without previous anxiolytic, sedative and analgesic medication No pregnancy or lactating Informed consent Outcome measures: Anxiety level Heart rate, blood pressure Salivary α-amylase

    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
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    37 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Auricular stimulation
    Arm Type
    Active Comparator
    Arm Description
    Auricular acupuncture with indwelling fixed auricular acupuncture needles
    Arm Title
    Expressive writing
    Arm Type
    Experimental
    Arm Description
    Expressive writing - sharing the emotional expectations in front of forthcoming exam
    Arm Title
    No intervention
    Arm Type
    No Intervention
    Arm Description
    No intervention, just observation and monitoring of outcome measures
    Intervention Type
    Device
    Intervention Name(s)
    Auricular acupuncture
    Intervention Description
    Auricular acupuncture with indwelling fixed auricular acupuncture needles
    Intervention Type
    Behavioral
    Intervention Name(s)
    Expressive writing
    Intervention Description
    Expressive writing is a standard psychological method in treatment of exam anxiety
    Primary Outcome Measure Information:
    Title
    Intensity of anxiety
    Description
    State-trait-Anxiety Inventory
    Time Frame
    2 days
    Secondary Outcome Measure Information:
    Title
    salivary alpha-amylase
    Description
    enzymatic activity of salivary alpha-amylase
    Time Frame
    1 day
    Title
    heart rate
    Description
    heart rate
    Time Frame
    1 day
    Title
    blood pressure
    Description
    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 Ability to express the thoughts and emotions ("expressive writing") Written informed consent Exclusion Criteria: Recidivist alcoholics Local auricular skin infection Pregnant or lactating women 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) Participants who are unable to understand the consent form History of psychiatric disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Taras Usichenko, MD. PhD
    Organizational Affiliation
    University Medicine of Greifswald
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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