MedDataX Logo

Auricular Acupuncture for Exam Anxiety in Medical Students

NCT ID: NCT02920164

Last Updated: 2016-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Number of volunteers: N = 40

Outcome measures: Anxiety level, Heart rate, blood pressure.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Auricular acupuncture

Auricular acupuncture with indwelling fixed auricular acupuncture needles

Group Type ACTIVE_COMPARATOR

Auricular acupuncture

Intervention Type DEVICE

Auricular acupuncture with indwelling permanent needles

Placebo acupuncture

Placebo acupuncture with placebo fixed "needles"

Group Type PLACEBO_COMPARATOR

Placebo acupuncture

Intervention Type DEVICE

Placebo acupuncture with placebo needles

Standard therapy

No intervention, just observation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Auricular acupuncture

Auricular acupuncture with indwelling permanent needles

Intervention Type DEVICE

Placebo acupuncture

Placebo acupuncture with placebo needles

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Exclusion Criteria

1. Local auricular skin infection
2. Pregnant or lactating women
3. 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)
4. Participants who are unable to understand the consent form
5. History of psychiatric disease, alcohol and drug abuse
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Taras Usichenko, MD, PhD

Role: STUDY_CHAIR

University Medicine of Greifswald

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medicine of Greifswald

Greifswald, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BB 49/12

Identifier Type: -

Identifier Source: org_study_id