Auricular Stimulation vs. Relaxation for Pre-exam Anxiety (AAvsPMR)
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auricular stimulation
Relaxation
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 understand and perform PMR
- 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
Experimental
Experimental
No Intervention
Arm Label
Auricular stimulation
Muscle relaxation
No intervention
Arm Description
Auricular stimulation using indwelling auricular acupuncture needles
Progressive muscle relaxation according to Jacobsen
No intervention, just monitoring of outcome parameters
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
NCT03093571
First Posted
March 23, 2017
Last Updated
March 27, 2017
Sponsor
University Medicine Greifswald
1. Study Identification
Unique Protocol Identification Number
NCT03093571
Brief Title
Auricular Stimulation vs. Relaxation for Pre-exam Anxiety
Acronym
AAvsPMR
Official Title
Auricular Acupuncture vs. Progressive Muscle Relaxation 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 2015 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (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. progressive muscle relaxation for pre-exam anxiety - a randomised crossover study
Study period: 04 / 2015 - 07 / 2015
Principal Investigator: PD Dr. T. Usichenko Department of Anaesthesiology and Intensive Care, University Medicine of Greifswald
Aim of the study: To investigate the anxiolytic effect of AA vs. progressive muscle relaxation 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. Progressive muscle relaxation
Number of volunteers: N = 30
Healthy medical students at the University of Greifswald Participants of the oral anatomy exams in spring/summer 2015 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
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Auricular stimulation
Arm Type
Experimental
Arm Description
Auricular stimulation using indwelling auricular acupuncture needles
Arm Title
Muscle relaxation
Arm Type
Experimental
Arm Description
Progressive muscle relaxation according to Jacobsen
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention, just monitoring of outcome parameters
Intervention Type
Device
Intervention Name(s)
Auricular stimulation
Intervention Description
Auricular stimulation with indwelling fixed needles
Intervention Type
Behavioral
Intervention Name(s)
Relaxation
Intervention Description
Progressive muscle relaxation
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 understand and perform PMR
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
Catharina Klausenitz, MD. PhD
Organizational Affiliation
University Medicine of Greifswald
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Auricular Stimulation vs. Relaxation for Pre-exam Anxiety
We'll reach out to this number within 24 hrs