Clinical trial NCT06128512: Auricular Acupuncture Efficacy for Medical Students' Examination Anxiety
Official title: Evaluating the Efficacy of Auricular Acupuncture in Reducing Examination Anxiety Among Medical Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Anxiety, Exam
Keywords: anxiety
examination anxiety
acupuncture
auricular acupuncture
traditional medicine
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the State-Trait Anxiety Inventory Form Y1 (STAI-Y1) score
timeFrame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
Secondary outcomes:
measure: Changes in Visual Analog Scale (VAS) score for anxiety
timeFrame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
measure: Changes in Diastolic Blood Pressure
timeFrame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
measure: Changes in Systolic Blood Pressure
timeFrame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
measure: Changes in heart rate
timeFrame: immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)
measure: The examination score
timeFrame: up to 1 month
measure: Proportion of intervention-related adverse effects
timeFrame: during the intervention
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: Faculty of Traditional medicine, University of Medicine and Pharmacy at Ho Chi Minh City
Study officials:
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