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AcuTA: Acupuncture in Test Anxiety (AcuTA)

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Acupuncture
Laser Acupuncture
Sponsored by
Goethe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Test Anxiety focused on measuring acupuncture, test anxiety, neuroenhancer, placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Medical School, University of Regensburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Laser Acupuncture

Acupuncture

Arm Description

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.

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Test Anxiety on a Visual Analogue Scale
Visual Analogue Scale (ranging 0 to 10, with 10 being most anxious)
Primary Appraisal Secondary Appraisal
validated questionnaire
Multidimensional Mood State Questionnaire
validated questionnaire
State Trait Anxiety Questionnaire
validated questionnaire
alpha amylase in saliva

Full Information

First Posted
April 24, 2014
Last Updated
January 6, 2015
Sponsor
Goethe University
Collaborators
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02142231
Brief Title
AcuTA: Acupuncture in Test Anxiety
Acronym
AcuTA
Official Title
Acupuncture Randomized Trial for Preventing Test Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University
Collaborators
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Test Anxiety, Experimental Setting (Trier Social Stress Test TSST)
Keywords
acupuncture, test anxiety, neuroenhancer, placebo

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser Acupuncture
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Acupuncture
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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
Intervention Name(s)
Laser Acupuncture
Intervention Description
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 Outcome Measure Information:
Title
Cortisol in saliva
Description
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.
Time Frame
8 timepoints (in minutes: -40;-10;+10;+20;+30;+40;+55;+70)
Secondary Outcome Measure Information:
Title
Test Anxiety on a Visual Analogue Scale
Description
Visual Analogue Scale (ranging 0 to 10, with 10 being most anxious)
Time Frame
4 timepoints (in minutes: -40;-10;+20;+55)
Title
Primary Appraisal Secondary Appraisal
Description
validated questionnaire
Time Frame
2 timepoints (-40 and +10 minutes)
Title
Multidimensional Mood State Questionnaire
Description
validated questionnaire
Time Frame
4 timepoints )in minutes: -40;-10;+10;+20)
Title
State Trait Anxiety Questionnaire
Description
validated questionnaire
Time Frame
3 timepoints (in minutes: -40;-10;+10)
Title
alpha amylase in saliva
Time Frame
6 timepoints (in minutes: -40;-10;+10;+20;+30;+55)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Medical School, University of Regensburg
City
Germany
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany

12. IPD Sharing Statement

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AcuTA: Acupuncture in Test Anxiety

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