Evaluating the Efficacy of Auricular Acupuncture in Reducing Examination Anxiety Among Medical Students
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Changes in the State-Trait Anxiety Inventory Form Y1 (STAI-Y1) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical students preparing to take an examination for a course experience anxiety with a STAI-Y1 score of 40 or higher.
- •Voluntary informed consent.
排除标准
- •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.
结局指标
主要结局
Changes in the State-Trait Anxiety Inventory Form Y1 (STAI-Y1) score
时间窗: 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.
次要结局
- Changes in Visual Analog Scale (VAS) score for anxiety(immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2))
- The examination score(up to 1 month)
- Proportion of intervention-related adverse effects(during the intervention)
- Changes in Diastolic 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))
- Changes in Systolic Blood Pressure(immediately pre-intervention (T0), 30 minutes (T1), 24 hours (T2))
研究者
Bui Pham Minh Man
Investigator
University of Medicine and Pharmacy at Ho Chi Minh City