Auricular Stimulation vs. Relaxation for Pre-exam Anxiety (AAvsPMR)

Auricular Acupuncture vs. Progressive Muscle Relaxation in Treatment of Pre-exam Anxiety - Randomised Crossover Study in Medical Students

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

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Device: Auricular stimulation; Behavioral: Relaxation

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 understand and perform PMR
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricular stimulation; Auricular stimulation using indwelling auricular acupuncture needles	Device: Auricular stimulation; Auricular stimulation with indwelling fixed needles
Experimental: Muscle relaxation; Progressive muscle relaxation according to Jacobsen	Behavioral: Relaxation; Progressive muscle relaxation
No Intervention: No intervention; No intervention, just monitoring of outcome parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of anxiety	State-trait-anxiety-inventory	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary alpha-amylase	Enzymatic activity of salivary alpha-amylase	1 day
heart rate	heart rate	1 day
blood pressure	blood pressure	1 day

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Principal Investigator: Catharina Klausenitz, MD. PhD, University Medicine of Greifswald

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: BB 041/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No