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Completed

NCT Number: NCT03093571

Auricular Stimulation vs. Relaxation for Pre-exam Anxiety

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

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auricular stimulation

Device

Auricular stimulation with indwelling fixed needles

Relaxation

Behavioral

Progressive muscle relaxation

Primary outcomes

  1. Intensity of anxiety

    Time frame: 2 days

    State-trait-anxiety-inventory

Secondary outcomes

  1. Salivary alpha-amylase

    Time frame: 1 day

    Enzymatic activity of salivary alpha-amylase

  2. heart rate

    Time frame: 1 day

    heart rate

  3. blood pressure

    Time frame: 1 day

    blood pressure

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

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

Acronym: AAvsPMR

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 28, 2017
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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