Efficacy of Non-invasive Auricular Simulation for Exam Anxiety and Depression in University Students: A Pilot 3-arm Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Recruitment strategy effectiveness
研究概览
简要总结
In Spain, depression, anxiety, and stress are highly prevalent in the general population as well as in college students. In college students, Ramón Arbués et al. found a moderate prevalence of depression (18.4%), anxiety (23.6%) and stress (34.5%). It is essential to take responsibility for promoting health education, disease prevention, protection and care for young people.
Academic performance can be altered due to the stressful nature of exam situations, which can lead to increased anxiety and decrease expected performance, mainly due to effects such as decreased attention span, concentration and retention of information.
Modulation of vagal tone is a therapeutical strategy to heightened parasympathetic activity and withdrawal sympathetic activity. Auricular transcutaneous VNS (ATVNS) by which parasympathetic nerve system is modulated by means of the stimulation of the auricular branch of the vagus nerve that provides somatosensory innervation to the external ear.
It has been shown that there are different effective interventions to reduce the symptoms of stress, depression, anxiety and insomnia in university students, but they are based on psychological interventions or face-to-face and cognitive-behavioral therapeutic approach, so this study proposal incorporates noninvasive atrial stimulation as an alternative to traditional treatments, which apart from being cost-effective, is easy to apply, well tolerated and presumably can have beneficial effects in the short term.
In the present pilot study, authors propose to investigate the degree of depression, anxiety and stress on crucial dates of final exams of 1st year students of the Double Degree Physiotherapy - Physical Activity and Sport Sciences of the Health Department of the TecnoCampus.
Investigators will also evaluate the feasibility of a study to assess the efficacy of a non-pharmacological intervention, through a neuroreflex stimulation of vagal tone, with a non-invasive atrial stimulation protocol.
详细描述
Personal pronouns have been removed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old
- •Tecnocampus undergraduate students from Physical Therapy and Sports Science Double Degree of 1rst course.
- •To sign the informed consent
- •Understand Catalan or Spanish language
- •With the intention to attend to the first call exams of the 2nd trimester.
排除标准
- •Receiving pharmacological medication for anxiety or mental disorders
- •Receiving psychological treatment
- •Pregnancy or breastfeeding
- •Participants with part-time enrolment
- •With skin lesions in both auricula,
- •Participating in another study
研究组 & 干预措施
True non-invasive auricular stimulation (TniAS)
Ear stimulation using true ear patches
干预措施: Non-invasive auricular stimulation (Other)
Sham auricular stimulation (SAS)
Ear stimulation using sham ear patches
干预措施: Sham auricular stimulation (SAS) (Other)
No-intervention group (NI)
Participants in the No-Intervention group (NI) will not receive any active intervention as part of the trial.
结局指标
主要结局
Recruitment strategy effectiveness
时间窗: Week 0
o evaluate the effectiveness of our recruitment strategy, we will analyze several key metrics, including the number of eligible participants, the number who expressed interest by completing the initial form, the participants who proceeded to the initial interview, and finally, the number of students who enrolled in the study. Additionally, we will carefully examine the reasons provided by students who declined to participate, allowing us to refine our recruitment approach.
Safety and Tolerability
时间窗: Week 2
Any side effects that may arise during the study will be meticulously monitored, and their frequency and severity will be assessed based on patients' self-reports. These side effects will be categorized as either minor, relevant, or important according to the patients' descriptions and assessments. Additionally, we will maintain a record of the number of participants who chose to remove at least one of the patches due to the side effects they experienced
次要结局
- Dropout rate(Week 2)
- Anxiety(Week 2)
- Exclusion rate(Week 0)
- Participant blinding success:(Week 2)
- Outcome assessor blinding success(Week 2)
- Stress(Week 2)
- Compliance to the intervention protocol(Week 2)
- Data collection feasibility(Week 2)
- Depression(Week 2)
- Insomnia(Week 2)