Transcutaneous Vagus Nerve Stimulation (tVNS) and Stress Regulation During Performance Tasks
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Self-Reported Stress
研究概览
简要总结
This study examines how individuals respond to performance-related tasks and whether a non-invasive ear stimulation device influences stress responses during those tasks. Participants will be randomly assigned to use either an active or inactive (placebo) version of a transcutaneous vagus nerve stimulation (tVNS) device during a laboratory session.
The study includes two task conditions. In one condition, participants will prepare a brief speech under evaluative conditions designed to induce stress. In the other condition, participants will complete a non-evaluative writing task. During the session, participants will wear a heart rate monitor and complete short questionnaires assessing their current feelings, including state anxiety.
The primary objective is to determine whether active tVNS is associated with lower state anxiety during a performance-related stress task compared to placebo stimulation. Secondary outcomes include heart rate and task-related responses. The study will also examine whether individual differences in stress reactivity influence responses to stimulation.
Participation involves one laboratory session lasting approximately 45 minutes.
详细描述
This study is a laboratory-based, randomized, double-blind experiment designed to examine whether non-invasive transcutaneous vagus nerve stimulation (tVNS) influences state anxiety and physiological arousal during performance-related stress.
Participants will be randomly assigned to one of four conditions in a 2 × 2 between-subjects factorial design:
Device Condition:
Active tVNS
Placebo (inactive) tVNS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are blinded to device condition (active vs sham stimulation). Study personnel interacting with participants and collecting outcome data are blinded to condition assignment. Devices are pre-programmed and coded to maintain masking throughout the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Adults aged 18 to 65 years
- •Fluent in English
- •Able to provide informed consent
- •Able to complete study procedures during a single laboratory session
排除标准
- •- History of neurological or psychiatric disorders
- •Cardiovascular disease or uncontrolled hypertension
- •Implanted electrical devices (e.g., pacemaker)
- •Current pregnancy
- •Contraindications to transcutaneous vagus nerve stimulation (tVNS)
- •Current use of medications that significantly affect autonomic nervous system functioning
研究组 & 干预措施
Active tVNS
Participants receive active transcutaneous vagus nerve stimulation (tVNS). Participants also complete either an evaluative stress task or a non-evaluative control task as part of the factorial design.
干预措施: Transcutaneous Vagus Nerve Stimulation (tVNS) (Device)
Active tVNS
Participants receive active transcutaneous vagus nerve stimulation (tVNS). Participants also complete either an evaluative stress task or a non-evaluative control task as part of the factorial design.
干预措施: Evaluative Stress Task (Behavioral)
Sham Comparator
Participants receive sham transcutaneous vagus nerve stimulation. Participants also complete either an evaluative stress task or a non-evaluative control task as part of the factorial design.
干预措施: Transcutaneous Vagus Nerve Stimulation (tVNS) (Device)
Sham Comparator
Participants receive sham transcutaneous vagus nerve stimulation. Participants also complete either an evaluative stress task or a non-evaluative control task as part of the factorial design.
干预措施: Evaluative Stress Task (Behavioral)
结局指标
主要结局
Self-Reported Stress
时间窗: Baseline (pre-task) and immediately post-task during a single laboratory session.
Self-reported stress assessed using a questionnaire/scale administered before and after the performance task to capture changes in perceived stress during the laboratory session.
次要结局
未报告次要终点