Auricular Acupuncture Efficacy for Medical Students' Examination Anxiety

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06128512
• Other study ID #: 698/HDDD-DHYD
• Status: Completed
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: April 28, 2024

Study information

• Verified date: April 2024
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 28, 2024
• Est. primary completion date: March 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

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 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.

Locations

Country	Name	City	State
Vietnam	Faculty of Traditional medicine, University of Medicine and Pharmacy at Ho Chi Minh City	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

References & Publications (12)

Amorim D, Amado J, Brito I, Fiuza SM, Amorim N, Costeira C, Machado J. Acupuncture and electroacupuncture for anxiety disorders: A systematic review of the clinical research. Complement Ther Clin Pract. 2018 May;31:31-37. doi: 10.1016/j.ctcp.2018.01.008. Epub 2018 Jan 31. — View Citation

Bae H, Bae H, Min BI, Cho S. Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:850367. doi: 10.1155/2014/850367. Epub 2014 Sep 2. — View Citation

Fares J, Al Tabosh H, Saadeddin Z, El Mouhayyar C, Aridi H. Stress, Burnout and Coping Strategies in Preclinical Medical Students. N Am J Med Sci. 2016 Feb;8(2):75-81. doi: 10.4103/1947-2714.177299. — View Citation

Favre-Felix J, Laurent V, Branche P, Huissoud C, Raffin M, Pradat P, Aubrun F, Dziadzko M. Auricular Acupuncture for Preoperative Anxiety in Parturient Women with Scheduled Cesarean Section: A Randomized Placebo-Controlled Blind Study. J Integr Complement Med. 2022 Jul;28(7):569-578. doi: 10.1089/jicm.2021.0346. Epub 2022 Apr 8. — View Citation

Karst M, Winterhalter M, Munte S, Francki B, Hondronikos A, Eckardt A, Hoy L, Buhck H, Bernateck M, Fink M. Auricular acupuncture for dental anxiety: a randomized controlled trial. Anesth Analg. 2007 Feb;104(2):295-300. doi: 10.1213/01.ane.0000242531.12722.fd. — View Citation

Li M, Li WQ, Li LMW. Sensitive Periods of Moving on Mental Health and Academic Performance Among University Students. Front Psychol. 2019 Jun 13;10:1289. doi: 10.3389/fpsyg.2019.01289. eCollection 2019. — View Citation

Mboya IB, John B, Kibopile ES, Mhando L, George J, Ngocho JS. Factors associated with mental distress among undergraduate students in northern Tanzania. BMC Psychiatry. 2020 Jan 29;20(1):28. doi: 10.1186/s12888-020-2448-1. — View Citation

Michalek-Sauberer A, Gusenleitner E, Gleiss A, Tepper G, Deusch E. Auricular acupuncture effectively reduces state anxiety before dental treatment--a randomised controlled trial. Clin Oral Investig. 2012 Dec;16(6):1517-22. doi: 10.1007/s00784-011-0662-4. Epub 2012 Jan 6. — View Citation

Remes O, Brayne C, van der Linde R, Lafortune L. A systematic review of reviews on the prevalence of anxiety disorders in adult populations. Brain Behav. 2016 Jun 5;6(7):e00497. doi: 10.1002/brb3.497. eCollection 2016 Jul. — View Citation

Roest AM, Martens EJ, de Jonge P, Denollet J. Anxiety and risk of incident coronary heart disease: a meta-analysis. J Am Coll Cardiol. 2010 Jun 29;56(1):38-46. doi: 10.1016/j.jacc.2010.03.034. — View Citation

Wang SM, Peloquin C, Kain ZN. The use of auricular acupuncture to reduce preoperative anxiety. Anesth Analg. 2001 Nov;93(5):1178-80, table of contents. doi: 10.1097/00000539-200111000-00024. — View Citation

Zanella S, Buccelletti F, Vassiliadis A, De Bortoli R, Visentini S, Pedrotti G, Azzalin L. Preoperative anxiety management: acupuncture vs. pharmacological treatment - A prospective study. Eur Rev Med Pharmacol Sci. 2022 Feb;26(3):900-905. doi: 10.26355/eurrev_202202_27999. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the State-Trait Anxiety Inventory Form Y1 (STAI-Y1) score	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	Changes in Visual Analog Scale (VAS) score for anxiety	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)
Secondary	Changes in Diastolic Blood Pressure	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)
Secondary	Changes in Systolic Blood Pressure	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)
Secondary	Changes in heart rate	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)
Secondary	The examination score	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
Secondary	Proportion of intervention-related adverse effects	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