Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Perceived Stress and Psychological Distress in University Students With High Distress Levels: A Randomized Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Psychological Distress (K10)
研究概览
简要总结
The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) works to reduce perceived stress and psychological distress in university students with high distress levels. The main questions it aims to answer are:
- Does taVNS reduce perceived stress (measured by PSS-10) in university students with high psychological distress?
- Does taVNS reduce psychological distress (measured by K10) in university students with high psychological distress?
- Is the intervention feasible and tolerable for implementation in higher-education mental health support?
Researchers will compare taVNS (electrode placed on the left tragus) to a sham stimulation group (electrode placed on the left earlobe) to see if taVNS reduces stress and distress.
Participants will:
- Attend five consecutive daily 30-minute stimulation sessions
- Complete stress and distress questionnaires before the intervention, immediately after, and at 1-month follow-up
- Receive electrical stimulation at individually adjusted intensity using the Nurosym device (pulse width 250 µs, frequency 20 Hz).
详细描述
Mental health is increasingly recognized as a core component of overall health, reflecting the capacity to regulate behavior, maintain daily functioning, and sustain satisfying interpersonal relationships. Chronic exposure to adverse circumstances, particularly prolonged stress, has been associated with mental health problems and contributes to the onset and maintenance of common psychological disorders.
University students are exposed to multiple risk stressors (psychological, academic, biological, lifestyle, social, and economic) associated with poorer well-being. The transition to higher education often coincides with entry into adulthood and is frequently described as a particularly demanding period in emotional and mental terms. Students commonly report high stress while adapting to academic demands that may exceed previously acquired skills and coping strategies. Stressors in this setting often include academic pressure, peer competition, ineffective time management, financial concerns, work-life conflicts, and mental overload from multiple responsibilities.
Sustained exposure to these stressors is associated with poorer learning performance, physical health problems, and sleep disturbances. High and persistent stress, especially when perceived as uncontrollable and excessive, is frequently associated with higher psychological distress among university students. In turn, psychological distress is associated with elevated anxiety and depressive symptoms, sleep problems, reduced self-esteem and self-efficacy, and in more severe presentations, with self-injury, suicidal ideation, substance use, and neglect of academic responsibilities.
International literature has reported high burden and, in some settings, worsening trends in university student mental health over the last decade, positioning it as a relevant public health concern. In the WHO World Mental Health International College Student Initiative, 93.7% of 20,842 students across 24 universities in nine countries experienced some level of stress. In Portugal, similar concerning patterns have been reported: at the University of Lisbon, one quarter of 7,756 students presented severe or very severe stress levels, and a further survey indicated that nearly half of 2,084 students reported psychological symptoms and about one quarter had considered suicide.
Multiple approaches have been used to address stress-related mental health problems in university students, including psychotropic medication, cognitive-behavioral therapy, mindfulness-based interventions, relaxation techniques, and biofeedback-based strategies. However, pharmacological approaches may be limited by side effects and other constraints, and many effective interventions require time, staffing, or infrastructure that can restrict scalability in academic settings. These limitations underscore the need to evaluate complementary interventions that are feasible, acceptable, and implementable in university contexts.
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
- Double (Participant, Outcomes Assessor)
盲法说明
This is a blinded clinical trial where participants are not informed of their group allocation (taVNS vs sham). Both groups undergo identical procedures with the same stimulation device, parameters, and session duration; the only difference is electrode placement (tragus vs earlobe). Outcomes are assessed via self-report questionnaires completed by participants who remain blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being a university student
- •Age ≥18 years
- •High to very high levels of psychological distress (K10 score ≥22)
排除标准
- •Psychotropic medication initiation or dose change within the last 3 months
- •Substance dependence
- •Current psychological or psychotherapeutic treatment
- •Any formal mental disorder diagnosis
- •Pregnancy
- •History of dizziness or seizures
- •Cochlear implants
- •Ear plastic surgery
- •Auricular malformations
研究组 & 干预措施
taVNS - Tragus Stimulation (Initial Treatment Only)
Participants received only active taVNS during the randomized phase; no cross-over to other interventions occurred during the trial.
干预措施: taVNS (Device)
Sham - Earlobe Stimulation (Initial Treatment Only)
Participants received only sham stimulation during the randomized phase. No cross-over procedures were included in the registered study design or analyses.
干预措施: Sham (Device)
结局指标
主要结局
Psychological Distress (K10)
时间窗: Baseline (pre-intervention), immediately post-intervention (after 5 daily sessions, approximately day 5), and 1-month follow-up
Psychological distress assessed using the 10-item Kessler Psychological Distress Scale (K10). Scored 1 ("never") to 5 ("always") with reference to the prior 30 days and summed to a total score of 10-50, with higher scores indicating higher distress.
Perceived Stress (PSS-10)
时间窗: Baseline (pre-intervention), immediately post-intervention (after 5 daily sessions, approximately day 5), and 1-month follow-up
Perceived stress assessed using the 10-item Perceived Stress Scale (PSS-10). Scored 0 ("never") to 4 ("very often") and summed to a total score of 0-40, with higher scores indicating higher perceived stress.
Feasibility (Retention Rate)
时间窗: From randomization through 1-month follow-up
Feasibility was assessed using retention of participants from baseline to the end of the study. For each arm, the number of randomized participants who completed all five stimulation sessions and the 1-month follow-up assessment was recorded.
Tolerability (Adverse Events / Dropout Due to AEs)
时间窗: From the first to the fifth stimulation session (Days 1-5), with adverse events assessed immediately before and after each intervention session.
Tolerability was assessed by monitoring adverse events before and after each session through visual inspection of the stimulation site and open-ended participant self-report questioning. The number of participants who discontinued participation due to any adverse event was recorded.
Change in Psychological Distress (K10)
时间窗: Baseline (pre-intervention), immediately post-intervention (after 5 daily sessions, approximately day 5), and 1-month follow-up
Psychological distress assessed using the 10-item Kessler Psychological Distress Scale (K10). Scored 1 ("never") to 5 ("always") with reference to the prior 30 days and summed to a total score of 10-50, with higher scores indicating higher distress.
Change in Perceived Stress (PSS-10)
时间窗: Baseline (pre-intervention), immediately post-intervention (after 5 daily sessions, approximately day 5), and 1-month follow-up
Perceived stress assessed using the 10-item Perceived Stress Scale (PSS-10). Scored 0 ("never") to 4 ("very often") and summed to a total score of 0-40, with higher scores indicating higher perceived stress.
次要结局
未报告次要终点
