Auricular Acupuncture Efficacy for Medical Students' Examination Anxiety

NCT06128512 | Completed

• 1 other identifier: 698/HDDD-DHYD
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Anxiety, Exam

Keywords

anxiety; examination anxiety; acupuncture; auricular acupuncture; traditional medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Changes in Visual Analog Scale (VAS) score for anxiety

  immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)

• Changes in Diastolic Blood Pressure

  immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)

• Changes in Systolic Blood Pressure

  immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)

• Changes in heart rate

  immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2)

• The examination score

  up to 1 month

Study Arms (2)

AA

EXPERIMENTAL

Auricular acupuncture (AA) 24 hours before the examination.

Other: Auricular acupuncture

Sham-AA

SHAM COMPARATOR

Sham Auricular acupuncture (Sham-AA) 24 hours before the examination.

Other: Sham Auricular acupuncture

Interventions

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.

AA

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.

Sham-AA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

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

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (12)

• 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.

  PMID: 27458547 BACKGROUND

• 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.

  PMID: 20620715 BACKGROUND

• 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.

  PMID: 31996200 BACKGROUND

• 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.

  PMID: 27042604 BACKGROUND

• 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.

  PMID: 31263436 BACKGROUND

• 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.

  PMID: 25254059 BACKGROUND

• 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.

  PMID: 29705474 BACKGROUND

• 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.

  PMID: 17242083 BACKGROUND

• 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.

  PMID: 35179756 BACKGROUND

• 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.

  PMID: 22219023 BACKGROUND

• 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.

  PMID: 11682391 BACKGROUND

• 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.

  PMID: 35394895 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 13, 2023
• Study Start: November 15, 2023
• Primary Completion: March 27, 2024
• Study Completion: April 28, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

VN (1)