AnxietyAAvsPMRNCT03093571
Auricular Stimulation vs. Relaxation for Pre-exam Anxiety
A study testing Auricular stimulation and Relaxation in people with Anxiety, run by University Medicine Greifswald.
Trial 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. 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 stimulation and Relaxation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jul 2015
- Phase
- Interventional
- 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
- Ability to understand and perform PMR
- Written informed consent
Who cannot join
- 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
About this study
Official title: Auricular Acupuncture vs. Progressive Muscle Relaxation in Treatment of Pre-exam Anxiety - Randomised Crossover Study in Medical Students
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
Read more
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
- Conditions
- Anxiety
- Being tested
- Auricular stimulation, Relaxation
- 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 stimulationDevice
Auricular stimulation with indwelling fixed needles
RelaxationBehavioural
Progressive muscle relaxation
| Study group | Role | What they receive |
|---|---|---|
| Auricular stimulation | Experimental | Auricular stimulation using indwelling auricular acupuncture needles Receives: Device: Auricular stimulation |
| Muscle relaxation | Experimental | Progressive muscle relaxation according to Jacobsen Receives: Behavioral: Relaxation |
| No intervention | No intervention | No intervention, just monitoring of outcome parameters |
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 (3)
Salivary alpha-amylase
Enzymatic activity of salivary alpha-amylase
Measured: 1 day
heart rate
heart rate
Measured: 1 day
blood pressure
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 posted28 Mar 2017
- Study startApr 2015
- Primary completionJul 2015
- Study completionJul 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catharina Klausenitz, MD. PhD, Principal investigator, University Medicine of Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093571
- Sponsor's protocol ID
- BB 041/15
- Acronym
- AAvsPMR
- Status last verified
- Mar 2017
- First submitted
- 23 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture vs. Progressive Muscle Relaxation in Treatment of Pre-exam Anxiety - Randomised Crossover Study in Medical Students
- ClinicalTrials.gov ID
- NCT03093571
- Acronym / sponsor ID
- AAvsPMR / BB 041/15
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Mar 2017 (actual)
- 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) 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
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 stimulation | Experimental | Device: Auricular stimulationAuricular stimulation using indwelling auricular acupuncture needles |
| Muscle relaxation | Experimental | Behavioral: RelaxationProgressive muscle relaxation according to Jacobsen |
| No intervention | No intervention | –No intervention, just monitoring of outcome parameters |
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
- Ability to understand and perform PMR
- Written informed consent
Key exclusion criteria (6 listed)
- 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
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 stimulationAuricular stimulation with indwelling fixed needles | Device | Auricular stimulation |
| RelaxationProgressive muscle relaxation | Behavioural | Muscle relaxation |
Primary outcome
Intensity of anxiety
Time frame: 2 days
State-trait-anxiety-inventory
3 secondary outcomes
Salivary alpha-amylase
Time frame: 1 day
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 29 Mar 2017.
- 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.
Catharina Klausenitz, MD. PhD principal investigator
University Medicine of Greifswald
Questions about this trial
What is this clinical trial studying?
A study testing Auricular stimulation and Relaxation in people with Anxiety, run by University Medicine Greifswald.
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 6 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 29 Mar 2017.