AnxietyPhase 2AAAnxNCT02920164
Auricular Acupuncture for Exam Anxiety in Medical Students
A Phase 2 study testing Auricular acupuncture in people with Anxiety, run by University Medicine Greifswald at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Auricular acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2012to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Auricular Acupuncture for Exam Anxiety in Medical Students: A Randomized Crossover Investigation
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:
- AA using indwelling fixed needles, retained 24 h in situ
- AA using placebo needles
Number of volunteers: N = 40
Outcome measures: Anxiety level, Heart rate, blood pressure.
- Conditions
- Anxiety
- Being tested
- Auricular acupuncture, Placebo acupuncture
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupunctureDevice
Auricular acupuncture with indwelling permanent needles
Placebo acupunctureDevice
Placebo acupuncture with placebo needles
| Study group | Role | What they receive |
|---|---|---|
| Auricular acupuncture | Active comparator | Auricular acupuncture with indwelling fixed auricular acupuncture needles Receives: Device: Auricular acupuncture |
| Placebo acupuncture | Placebo comparator | Placebo acupuncture with placebo fixed "needles" Receives: Device: Placebo acupuncture |
| Standard therapy | No intervention | No intervention, just observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of anxiety
State-Trait-Anxiety Inventory
Measured: 2 days
Secondary outcomes (2)
heart rate
Measured: 1 day
blood pressure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startApr 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taras Usichenko, MD, PhD, Study chair, University Medicine of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920164
- Sponsor's protocol ID
- BB 49/12
- Acronym
- AAAnx
- Status last verified
- Sep 2016
- First submitted
- 28 Sep 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture for Exam Anxiety in Medical Students: A Randomized Crossover Investigation
- ClinicalTrials.gov ID
- NCT02920164
- Acronym / sponsor ID
- AAAnx / BB 49/12
- Conditions
- Anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- AA using indwelling fixed needles, retained 24 h in situ
- AA using placebo needles
Number of volunteers: N = 40
Outcome measures: Anxiety level, Heart rate, blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auricular acupuncture | Active comparator | Device: Auricular acupunctureAuricular acupuncture with indwelling fixed auricular acupuncture needles |
| Placebo acupuncture | Placebo comparator | Device: Placebo acupuncturePlacebo acupuncture with placebo fixed "needles" |
| Standard therapy | No intervention | –No intervention, just observation |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupunctureAuricular acupuncture with indwelling permanent needles | Device | Auricular acupuncture |
| Placebo acupuncturePlacebo acupuncture with placebo needles | Device | Placebo acupuncture |
Primary outcome
Intensity of anxiety
Time frame: 2 days
State-Trait-Anxiety Inventory
2 secondary outcomes
heart rate
Time frame: 1 day
blood pressure
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taras Usichenko, MD, PhD study chair
University Medicine of Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Auricular acupuncture in people with Anxiety, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of anxiety (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2016.