Auricular Acupuncture Efficacy for Medical Students' Examination Anxiety

November 27, 2023 updated by: Bui Pham Minh Man, University of Medicine and Pharmacy at Ho Chi Minh City

Evaluating the Efficacy of Auricular Acupuncture in Reducing Examination Anxiety Among Medical Students

Anxiety is a natural human response when facing challenging circumstances or threats to oneself. It is highly prevalent, estimated to range from 3.8% to 25%. Anxiety significantly impacts daily life and the overall quality of life. Of particular concern is the potential for anxiety to increase cardiovascular risk factors such as hypertension, a higher incidence of heart disease, and premature mortality.

Anxiety occurs in nearly everyone, but university students are particularly prone to experiencing anxiety and higher levels of mental stress compared to the general population. This trend is notably pronounced among medical students, a group with a significantly higher prevalence of anxiety that can reach as high as 90%. Multiple factors contribute to this anxiety and stress, notably the pressure of academic examinations.

Several studies suggest that acupuncture not only positively affects anxiety but also has fewer side effects compared to pharmacological treatments. Among these, a form of acupuncture known as auricular acupuncture (AA) is considered safe and has demonstrated effectiveness in reducing pre-surgical and dental anxiety. However, evidence supporting its effectiveness in reducing examination anxiety among medical students remains insufficient. Hence, in this study, we have designed a randomized controlled trial, including a placebo arm, to establish the efficacy and safety of AA in addressing this issue.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Medical students with examination anxiety, identified by a score equal to 40 or more on the STAI-Y1 scale, will be selected and randomly allocated into two groups: the intervention group (AA group) and the placebo group (Sham-AA), at a 1:1 allocation ratio.

The intervention will be carried out 24 hours before the examination and will be monitored until the students complete the test. In the AA group, AA devices will be utilized, while adhesive patches without needles will be used in the Sham-AA group.

Data regarding anxiety levels will be recorded through scores obtained from the STAI-Y1 questionnaire and VAS-100; heart rate, diastolic blood pressure, systolic blood pressure, examination scores, and adverse events will also be evaluated at various intervals.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh, Vietnam, 700000
        • Recruiting
        • Faculty of Traditional medicine, University of Medicine and Pharmacy at Ho Chi Minh City
        • Contact:
          • Minh-Man Pham Bui, Medical doctor
          • Phone Number: +84916080803
          • Email: bpmman@ump.edu.vn
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medical students preparing to take an examination for a course experience anxiety with a STAI-Y1 score of 40 or higher.
  • Voluntary informed consent.

Exclusion Criteria:

  • Currently experiencing additional anxiety alongside the impending examination anxiety.
  • Using stimulants within 24 hours prior.
  • Recent use of any drugs impacting intervention outcomes including psychotropic medications, blood pressure, and heart rate-affecting medications.
  • History of alcohol or substance addiction.
  • History of cardiac and neuropsychiatric disorders.
  • Prior experience with auricular acupuncture.
  • History of hypersensitivity reactions to any form of acupuncture with needles.
  • Existing injuries or lesions at the acupoints being investigated in this study.
  • Presence of severe medical conditions (e.g., cardiovascular, hepatic, renal, or others) that could potentially influence treatment outcomes as assessed by researchers.
  • Currently enrolled in another intervention study.
  • Pregnancy or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AA
Auricular acupuncture (AA) 24 hours before the examination.
Other: Auricular acupuncture
Auricular acupuncture is administered 24 hours before the examination using patches, each possessing a square shape with a side length of 10 mm, coupled with a sterilized needle measuring 0.25 x 1.3 mm. Four acupoints are selected on one ear, including the Master cerebral point, Tranquilizer point, Relaxation point, and Heart point (CO15). The patch containing the needle will remain in place until the student completes the examination.
Sham Comparator: Sham-AA
Sham Auricular acupuncture (Sham-AA) 24 hours before the examination.
Other: Sham Auricular acupuncture
Sham Auricular acupuncture is administered 24 hours before the examination using patches, each possessing a square shape with a side length of 10 mm, without a needle. Four acupoints are selected on one ear, including the Master cerebral point, Tranquilizer point, Relaxation point, and Heart point (CO15). The patch will remain in place until the student completes the examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in the State-Trait Anxiety Inventory Form Y1 (STAI-Y1) score
Time Frame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
The STAI-Y1 comprises 20 questions, each rated on a 4-point scale from 1 "not at all" to 4 "very much so". Therefore, the STAI-Y1 score ranges from 20 to 80, with higher scores indicating increased levels of anxiety.
immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Visual Analog Scale (VAS) score for anxiety
Time Frame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
The VAS includes a 100mm line with endpoints labeled from "no anxiety" to "greatest anxiety ever experienced". Participants will mark on the line the point that represents their current level of anxiety. The VAS score ranges from 0 to 100, with higher scores indicating increased levels of anxiety.
immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Changes in Diastolic Blood Pressure
Time Frame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Diastolic blood pressure is measured using an electronic device, in units of mmHg, conducted by investigators. The higher the value, the higher the diastolic blood pressure.
immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Changes in Systolic Blood Pressure
Time Frame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Systolic blood pressure is measured using an electronic device, in units of mmHg, conducted by investigators. The higher the value, the higher the systolic blood pressure.
immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Changes in heart rate
Time Frame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Heart rate is measured using an electronic device, in units of beats per minute, conducted by investigators. The higher the value, the faster the heart rate.
immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
The examination score
Time Frame: up to 1 month
The examination scores will be recorded after the students receive their test results. The scoring scale ranges from 0 to 10 points. Higher scores indicate a better performance on the examination.
up to 1 month
Proportion of intervention-related adverse effects
Time Frame: during the intervention

Anticipated adverse events (AEs) from auricular acupuncture (AA) may comprise pain at the insertion site, local discomfort, skin irritation (itching and redness), inflammation, bleeding, chondritis, dizziness, nausea, and hypersensitivity reactions.

Moreover, any unanticipated AEs related to AA will be recorded and observed.
during the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

April 15, 2024

Study Registration Dates

First Submitted

November 4, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 698/HDDD-DHYD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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