AcuTA: Acupuncture in Test Anxiety

NCT ID: NCT02142231

Last Updated: 2015-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-06-30

Brief 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.

Conditions

Test Anxiety; Experimental Setting (Trier Social Stress Test TSST)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Laser Acupuncture

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.

Group Type: PLACEBO_COMPARATOR

Laser Acupuncture

Intervention Type: 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.

Acupuncture

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)

Group Type: ACTIVE_COMPARATOR

Acupuncture

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: collaborator

Goethe University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Johannes Fleckenstein

Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical School, University of Regensburg

Germany, Bavaria, Germany

Countries

Germany

Other Identifiers

AcuTA

Identifier Type: -

Identifier Source: org_study_id