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NCT Number: NCT06128512

Auricular Acupuncture Efficacy for Medical Students' Examination Anxiety

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.

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Key information

Conditions

Anxiety Anxiety Disorders Anxiety, Exam Mental Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Traditional medicine, University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auricular Acupuncture

Other

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 auricular acupuncture

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2023
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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