Auricular Acupuncture Efficacy for Medical Students' Examination Anxiety

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City (Other)

Overall Status

Recruiting

CT.gov ID

NCT06128512

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

12.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Anxiety, Exam	Other: Auricular acupuncture Other: Sham Auricular acupuncture	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Participants will not know which group they are assigned to - either the intervention or placebo group. Sham auricular acupuncture (Sham-AA) will be administered similarly to AA but without the use of needles. The physician administering the treatments will be aware of the group assignments but will not be involved in result assessment or data analysis. Those responsible for outcome evaluation and data analysis will not know the treatment allocations.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

Mar 15, 2024

Anticipated Study Completion Date :

Apr 15, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Changes in the State-Trait Anxiety Inventory Form Y1 (STAI-Y1) score [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 Outcome Measures

Changes in Visual Analog Scale (VAS) score for anxiety [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.
Changes in Diastolic Blood Pressure [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.
Changes in Systolic Blood Pressure [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.
Changes in heart rate [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.
The examination score [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.
Proportion of intervention-related adverse effects [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.