NCT02920164

Brief Summary

Title of the study: Auricular acupuncture (AA) for pre-exam anxiety: A blinded randomized crossover study on healthy volunteers Study period: 04/2012 - 07/2012 Institution: Department of Anesthesiology and Intensive Care Medicine University Medicine of Greifswald Aim of the study: To investigate the anxiolytic effect of auricular acupuncture (AA) in comparison to placebo acupuncture and no intervention during oral exams in anatomy at the University of Greifswald Design: Prospective blinded randomized crossover trial Intervention:

  1. 1.AA using indwelling fixed needles, retained 24 h in situ
  2. 2.AA using placebo needles

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2 anxiety

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_2 anxiety

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

September 28, 2016

Last Update Submit

September 29, 2016

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

  • Intensity of anxiety

    State-Trait-Anxiety Inventory

    2 days

Secondary Outcomes (2)

  • heart rate

    1 day

  • blood pressure

    1 day

Study Arms (3)

Auricular acupuncture

ACTIVE COMPARATOR

Auricular acupuncture with indwelling fixed auricular acupuncture needles

Device: Auricular acupuncture

Placebo acupuncture

PLACEBO COMPARATOR

Placebo acupuncture with placebo fixed "needles"

Device: Placebo acupuncture

Standard therapy

NO INTERVENTION

No intervention, just observation

Interventions

Auricular acupunctureDEVICE

Auricular acupuncture with indwelling permanent needles

Auricular acupuncture
Placebo acupunctureDEVICE

Placebo acupuncture with placebo needles

Placebo acupuncture

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
  • Participants without any experiences with acupuncture
  • Patients who have given written informed consent

You may not qualify if:

  • Local auricular skin infection
  • Pregnant or lactating women
  • Participants with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolapse (risk of bacterial endocarditis according to guidelines of AHA)
  • Participants who are unable to understand the consent form
  • History of psychiatric disease, alcohol and drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medicine of Greifswald

Greifswald, Germany

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapy

Study Officials

  • Taras Usichenko, MD, PhD

    University Medicine of Greifswald

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
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

September 28, 2016

First Posted

September 30, 2016

Study Start

April 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 30, 2016

Record last verified: 2016-09

Locations

DE(1)