AcuTA: Acupuncture in Test Anxiety

Test Anxiety Clinical Trial

— AcuTA  

Official title:

Acupuncture Randomized Trial for Preventing Test Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142231
• Other study ID #: AcuTA
• Status: Completed
• Phase: N/A
• First received: April 24, 2014
• Last updated: January 6, 2015
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: January 2015
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety Disorders
• Experimental Setting (Trier Social Stress Test TSST)
• Test Anxiety

Intervention

Device:
• Acupuncture
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
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.

Locations

Country	Name	City	State
Germany	Medical School, University of Regensburg	Germany	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Goethe University	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 timepoints (in minutes: -40;-10;+10;+20;+30;+40;+55;+70)	No
Secondary	Test Anxiety on a Visual Analogue Scale	Visual Analogue Scale (ranging 0 to 10, with 10 being most anxious)	4 timepoints (in minutes: -40;-10;+20;+55)	No
Secondary	Primary Appraisal Secondary Appraisal	validated questionnaire	2 timepoints (-40 and +10 minutes)	No
Secondary	Multidimensional Mood State Questionnaire	validated questionnaire	4 timepoints )in minutes: -40;-10;+10;+20)	No
Secondary	State Trait Anxiety Questionnaire	validated questionnaire	3 timepoints (in minutes: -40;-10;+10)	No
Secondary	alpha amylase in saliva		6 timepoints (in minutes: -40;-10;+10;+20;+30;+55)	No