Auricular Stimulation vs. Relaxation for Pre-exam Anxiety

Anxiety Clinical Trial

— AAvsPMR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093571
• Other study ID #: BB 041/15
• Status: Completed
• Phase: N/A
• First received: March 23, 2017
• Last updated: March 27, 2017
• Start date: April 2015
• Est. completion date: July 2015

Study information

• Verified date: March 2017
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Device:
• Auricular stimulation
Auricular stimulation with indwelling fixed needles

Behavioral:
• Relaxation
Progressive muscle relaxation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of anxiety	State-trait-anxiety-inventory	2 days
Secondary	Salivary alpha-amylase	Enzymatic activity of salivary alpha-amylase	1 day
Secondary	heart rate	heart rate	1 day
Secondary	blood pressure	blood pressure	1 day