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

U

University Medicine Greifswald

Status

Completed

Conditions

Anxiety

Treatments

Device: Auricular stimulation
Behavioral: Relaxation

Study type

Interventional

Funder types

Other

Identifiers

NCT03093571
BB 041/15

Details and patient eligibility

About

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

Enrollment

47 patients

Sex

All

Ages

19 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

47 participants in 3 patient groups

Auricular stimulation
Experimental group
Description:
Auricular stimulation using indwelling auricular acupuncture needles
Treatment:
Device: Auricular stimulation
Muscle relaxation
Experimental group
Description:
Progressive muscle relaxation according to Jacobsen
Treatment:
Behavioral: Relaxation
No intervention
No Intervention group
Description:
No intervention, just monitoring of outcome parameters

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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