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
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
- 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
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
NCT ID
NCT03093584
First Posted
March 23, 2017
Last Updated
March 27, 2017
Sponsor
University Medicine Greifswald
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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Auricular Stimulation vs. Expressive Writing for Exam Anxiety
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