AcuTA: Acupuncture in Test Anxiety

NCT02142231 | Completed

• 1 other identifier: AcuTA
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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)

Keywords

acupuncture; test anxiety; neuroenhancer; placebo

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Test Anxiety on a Visual Analogue Scale

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

• Primary Appraisal Secondary Appraisal

  2 timepoints (-40 and +10 minutes)

• Multidimensional Mood State Questionnaire

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

• State Trait Anxiety Questionnaire

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

• alpha amylase in saliva

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

Study Arms (2)

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.

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)

Device: Acupuncture

Interventions

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

Acupuncture

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.

Laser Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Goethe University: lead
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

Medical School, University of Regensburg

Germany, Bavaria, 93053, Germany

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 20, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 7, 2015

Record last verified: 2015-01

Locations

DE (1)