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Clinical Trials/NCT02142231
NCT02142231CompletedNot Applicable

Acupuncture Randomized Trial for Preventing Test Anxiety

Goethe University1 site in 1 country25 target enrollmentStarted: April 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
25
Locations
1
Primary Endpoint
Cortisol in saliva

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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)

Arms & Interventions

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.

Intervention: Laser Acupuncture (Device)

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)

Intervention: Acupuncture (Device)

Outcomes

Primary Outcomes

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

  • 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))
  • alpha amylase in saliva(6 timepoints (in minutes: -40;-10;+10;+20;+30;+55))
  • State Trait Anxiety Questionnaire(3 timepoints (in minutes: -40;-10;+10))

Investigators

Sponsor
Goethe University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Johannes Fleckenstein

Dr. med.

Ludwig-Maximilians - University of Munich

Study Sites (1)

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