Trier Social Stress Test in Virtual Reality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change of levels of physical stress, HRV
研究概览
简要总结
Background The Trier Social Stress Test (TSST) is a valid and gold standard way for inducing psychosocial stress and is widely used in research and diagnostics. One of the downsides of the TSST is the difficulty to maintain the same experimental conditions repeatedly. A TSST in virtual reality (TSST-VR) is constant and requires far less time and personnel. Our TSST-VR version consist of three stress levels (no stress, moderate stress, high stress), a novelty in this field.
Aim The aim is to investigate whether there is a statistically significantly greater increase directly after the TSST-VR in psychological and physiological stress parameters in the moderate and high stress levels compared to the no stress condition (control).
Method A randomized controlled trial is conducted in healthy adults, with the three stress levels as conditions. Cortisol and questionnaires on anxiety and physical arousal are measured at baseline, during and after the TSST. Heart rate is measured continuously and adverse events are monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Healthy participants, not having a psychiatric diagnosis in the last three years or currently having an endocrine disorders
- •Aged between 18 and 65 years
- •Good understanding of the Dutch language
- •Normal or corrected-to-normal vision and hearing
排除标准
- •History of photosensitive epilepsy
- •Hearing loss
- •Pregnant woman
- •Women who breastfeed
- •Taking heart rate altering medication such as beta-blockers.
- •Pregnant woman and woman who breastfeed are excluded because they have a different hormone levels which can intervene with the stress reaction.
结局指标
主要结局
Change of levels of physical stress, HRV
时间窗: continuously during the whole procedure, in total 75 minuten
Change from baseline to 75 min
次要结局
- Change of levels of psychological stress, state anxiety inventory STAI(After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.)
- Social phobia(Baseline)
- Sociodemographics(baseline)
- Change of levels of physical stress, cortisol(After 20 minutes waiting period, after the stress test (+15min), after another 20min waiting period, and after another 20min waiting period.)
- Speech fluency(during the speech and math task, 10 minutes in total)
- Change of levels of physical stress, Skin conductance(continuously during the whole procedure, in total 75 minuten)