Test AnxietyAcuTANCT02142231
AcuTA: Acupuncture in Test Anxiety
A study testing Acupuncture and Laser Acupuncture in people with Test Anxiety and Experimental Setting (Trier Social Stress Test TSST), run by Goethe University at 1 site in Germany.
Trial summary
Test anxiety is a well-known phenomenon in general population, but only few scientific advances have been made in order to fully understand and prevent this circumstance. The number of students which use neuro enhancement to improve their performance and to prevent test anxiety, is increasing. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Test Anxiety, Experimental Setting (Trier Social Stress Test TSST)
- What is being tested?
- Acupuncture and Laser Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Jun 2014
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Test Anxiety in the clinical history
- Male medical students 3rd to 5th year
- Compliance
- Age > 18 years
- Smoking cessation for 24 hours
Who cannot join
- Severe physical or psychical illness
- Psychiatric record in medical history
- Continuous uptake of antipsychiatric medication, tranquilizers or neuro-enhancers
- Acupuncture treatment within the last 4 weeks
- Hang-over
- Drug consumption
- Smoking (> 5 cigarettes/ day)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical School, University of Regensburg
Germany, Bavaria, 93053
About this study
Official title: Acupuncture Randomized Trial for Preventing Test Anxiety
Test anxiety is a well-known phenomenon in general population, but only few scientific advances have been made in order to fully understand and prevent this circumstance.
The number of students which use neuro enhancement to improve their performance and to prevent test anxiety, is increasing. A US-survey estimated that almost 7% of students in US universities have used prescription stimulants against anxiety, and that on some campuses, up to 25% of students had used them in the past year.
Read more
Acupuncture might act as an alternate. Several trials could demonstrate, that different forms of acupuncture could relieve symptoms of pre-exam anxiety syndrome significantly and that this therapy was highly safe. In special, the investigation of single point effects in test anxiety could be of general interest. The acupuncture point with the most convincing evidence up to date is Heart 7. Yet, its effectiveness has mainly been chosen in combination with other acupuncture points and not as single remedy in test anxiety. Therefore we establish a trial investigating the immediate needling effects at Heart 7 on the reduction of test anxiety.
Therefore qe implemented a validated stress test, the Trier Social Stress Test TSST, which is known to provoke serious stress responses in healthy subjects. 24 medical students with test anxiety in there history will be randomised to two interventional groups (verum acupuncture and laser acupuncture), being treated and then pass this test. Main outcome is the increase of cortisol in saliva, which is the standardized measure of stress response used in this paradigm.
- Being tested
- Acupuncture, Laser Acupuncture
- Keywords
- acupuncture, test anxiety, neuroenhancer, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
Sterile Acupuncture Needles (Seirin (R) 0.15x0.2) will be used, Needles are inserted for approx. 0.5-1 cm until deqi response is elicited
Laser AcupunctureDevice
Therefore a laser irradiation is faked, approaching a nonfunctioning laser pen, which has been deactivated by the manufacturer (3B Scientific GmbH, Hamburg, Germany). Only red light is emitted. To further emphasize the imaginary power of this sham procedure, visual and acoustic signals accompany the red light emission. Patients are treated at the same acupuncture points as in the acupuncture group for one minute without skin contact. The resting time after treatment is 18 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Laser Acupuncture | Placebo comparator | Subjects and Therapists are blinded. Instead of a real Laser Acupuncture device (able to elicit physiologic responses) them is given a sham-laser device only radiating non-energetic red LED-light. Without palpation, therapists treat the acupoint Heart 7, on both wrists, each for 1 minute, with additional 18 minutes of resting time after. Receives: Device: Laser Acupuncture |
| Acupuncture | Active comparator | Acupuncture at the acupoint Heart 7, on both wrists, each for 1 minute, eliciting a deqi-response, additional stimulation and total needle-in time of 20 minutes (2 minutes treatment and 18 minutes of resting time) Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol in saliva
Saliva samples will be obtained at above mentioned intervals for subsequent analysis of cortisol a in saliva. The stress model used in this trial is supposed to elevate cortisol in saliva 3-5 fold in controls.
Measured: 8 timepoints (in minutes: -40;-10;+10;+20;+30;+40;+55;+70)
Secondary outcomes (5)
Test Anxiety on a Visual Analogue Scale
Visual Analogue Scale (ranging 0 to 10, with 10 being most anxious)
Measured: 4 timepoints (in minutes: -40;-10;+20;+55)
Primary Appraisal Secondary Appraisal
validated questionnaire
Measured: 2 timepoints (-40 and +10 minutes)
Multidimensional Mood State Questionnaire
validated questionnaire
Measured: 4 timepoints )in minutes: -40;-10;+10;+20)
State Trait Anxiety Questionnaire
validated questionnaire
Measured: 3 timepoints (in minutes: -40;-10;+10)
alpha amylase in saliva
Measured: 6 timepoints (in minutes: -40;-10;+10;+20;+30;+55)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Test 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, Dr. Johannes Fleckenstein, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142231
- Sponsor's protocol ID
- AcuTA
- Acronym
- AcuTA
- Status last verified
- Jan 2015
- First submitted
- 24 Apr 2014
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Randomized Trial for Preventing Test Anxiety
- ClinicalTrials.gov ID
- NCT02142231
- Acronym / sponsor ID
- AcuTA / AcuTA
- Keywords
- acupuncture, test anxiety, neuroenhancer, placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 May 2014 (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.
Test anxiety is a well-known phenomenon in general population, but only few scientific advances have been made in order to fully understand and prevent this circumstance.
The number of students which use neuro enhancement to improve their performance and to prevent test anxiety, is increasing. A US-survey estimated that almost 7% of students in US universities have used prescription stimulants against anxiety, and that on some campuses, up to 25% of students had used them in the past year.
Acupuncture might act as an alternate. Several trials could demonstrate, that different forms of acupuncture could relieve symptoms of pre-exam anxiety syndrome significantly and that this therapy was highly safe. In special, the investigation of single point effects in test anxiety could be of general interest. The acupuncture point with the most convincing evidence up to date is Heart 7. Yet, its effectiveness has mainly been chosen in combination with other acupuncture points and not as single remedy in test anxiety. Therefore we establish a trial investigating the immediate needling effects at Heart 7 on the reduction of test anxiety.
Therefore qe implemented a validated stress test, the Trier Social Stress Test TSST, which is known to provoke serious stress responses in healthy subjects. 24 medical students with test anxiety in there history will be randomised to two interventional groups (verum acupuncture and laser acupuncture), being treated and then pass this test. Main outcome is the increase of cortisol in saliva, which is the standardized measure of stress response used in this paradigm.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Acupuncture | Placebo comparator | Device: Laser AcupunctureSubjects and Therapists are blinded. Instead of a real Laser Acupuncture device (able to elicit physiologic responses) them is given a sham-laser device only radiating non-energetic red LED-light. Without palpation, therapists treat the acupoint Heart 7, on both wrists, each for 1 minute, with additional 18 minutes of resting time after. |
| Acupuncture | Active comparator | Device: AcupunctureAcupuncture at the acupoint Heart 7, on both wrists, each for 1 minute, eliciting a deqi-response, additional stimulation and total needle-in time of 20 minutes (2 minutes treatment and 18 minutes of resting time) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Test Anxiety in the clinical history
- Male medical students 3rd to 5th year
- Compliance
- Age > 18 years
- Smoking cessation for 24 hours
Key exclusion criteria (7 listed)
- Severe physical or psychical illness
- Psychiatric record in medical history
- Continuous uptake of antipsychiatric medication, tranquilizers or neuro-enhancers
- Acupuncture treatment within the last 4 weeks
- Hang-over
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 |
|---|---|---|
| AcupunctureSterile Acupuncture Needles (Seirin (R) 0.15x0.2) will be used, Needles are inserted for approx. 0.5-1 cm until deqi response is elicited | Device | Acupuncture |
| Laser AcupunctureTherefore a laser irradiation is faked, approaching a nonfunctioning laser pen, which has been deactivated by the manufacturer (3B Scientific GmbH, Hamburg, Germany). Only red light is emitted. To further emphasize the imaginary power of this sham procedure, visual and acoustic signals accompany the red light emission. Patients are treated at the same acupuncture points as in the acupuncture group for one minute without skin contact. The resting time after treatment is 18 minutes. | Device | Laser Acupuncture |
Primary outcome
Cortisol in saliva
Time frame: 8 timepoints (in minutes: -40;-10;+10;+20;+30;+40;+55;+70)
Saliva samples will be obtained at above mentioned intervals for subsequent analysis of cortisol a in saliva. The stress model used in this trial is supposed to elevate cortisol in saliva 3-5 fold in controls.
5 secondary outcomes
Test Anxiety on a Visual Analogue Scale
Time frame: 4 timepoints (in minutes: -40;-10;+20;+55)
Primary Appraisal Secondary Appraisal
Time frame: 2 timepoints (-40 and +10 minutes)
Multidimensional Mood State Questionnaire
Time frame: 4 timepoints )in minutes: -40;-10;+10;+20)
State Trait Anxiety Questionnaire
Time frame: 3 timepoints (in minutes: -40;-10;+10)
alpha amylase in saliva
Time frame: 6 timepoints (in minutes: -40;-10;+10;+20;+30;+55)
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 7 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and Laser Acupuncture in people with Test Anxiety and Experimental Setting (Trier Social Stress Test TSST), run by Goethe University 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 7 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 7 Jan 2015. 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.
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?
Cortisol in saliva (time frame: 8 timepoints (in minutes: -40;-10;+10;+20;+30;+40;+55;+70)). 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 7 Jan 2015.