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Completed

NCT Number: NCT02142231

AcuTA: Acupuncture in 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.

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Medical School, University of Regensburg

Germany, Bavaria, 93053

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Test Anxiety in the clinical history
  • Male medical students 3rd to 5th year
  • Compliance
  • Age > 18 years
  • Smoking cessation for 24 hours

Exclusion criteria

  • 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)

Treatment and study plan

acupuncture

Device

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 acupuncture

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Test Anxiety on a Visual Analogue Scale

    Time frame: 4 timepoints (in minutes: -40;-10;+20;+55)

    Visual Analogue Scale (ranging 0 to 10, with 10 being most anxious)

  2. Primary Appraisal Secondary Appraisal

    Time frame: 2 timepoints (-40 and +10 minutes)

    validated questionnaire

  3. Multidimensional Mood State Questionnaire

    Time frame: 4 timepoints )in minutes: -40;-10;+10;+20)

    validated questionnaire

  4. State Trait Anxiety Questionnaire

    Time frame: 3 timepoints (in minutes: -40;-10;+10)

    validated questionnaire

  5. alpha amylase in saliva

    Time frame: 6 timepoints (in minutes: -40;-10;+10;+20;+30;+55)

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Official study title

Acupuncture Randomized Trial for Preventing Test Anxiety

Acronym: AcuTA

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 20, 2014
Registry last updated
Jan 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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