NCT03093571

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable anxiety

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

March 23, 2017

Last Update Submit

March 27, 2017

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

  • Intensity of anxiety

    State-trait-anxiety-inventory

    2 days

Secondary Outcomes (3)

  • Salivary alpha-amylase

    1 day

  • heart rate

    1 day

  • blood pressure

    1 day

Study Arms (3)

Auricular stimulation

EXPERIMENTAL

Auricular stimulation using indwelling auricular acupuncture needles

Device: Auricular stimulation

Muscle relaxation

EXPERIMENTAL

Progressive muscle relaxation according to Jacobsen

Behavioral: Relaxation

No intervention

NO INTERVENTION

No intervention, just monitoring of outcome parameters

Interventions

Auricular stimulationDEVICE

Auricular stimulation with indwelling fixed needles

Auricular stimulation
RelaxationBEHAVIORAL

Progressive muscle relaxation

Muscle relaxation

Eligibility Criteria

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Catharina Klausenitz, MD. PhD

    University Medicine of Greifswald

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2017

First Posted

March 28, 2017

Study Start

April 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 29, 2017

Record last verified: 2017-03