Physiological Effects of Placebo Interventions to Increase or Decrease Blood Pressure
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Mean arterial pressure
研究概览
简要总结
A relevant reduction of blood pressure (BP) in placebo-treated control groups is a phenomenon often observed in pharmacological studies of hypertension. This effect was shown to differ from spontaneous remission tendencies and regression to the mean effect by comparing placebo groups with untreated controls. However, it is not fully understood whether these effects are due to a global reaction of the autonomous nervous system (affecting the overall organ systems of the body) or a specific reaction (affecting the cardiovascular system only). We therefore aim to differentiate specific effects (reduction of blood pressure) from global effects (e.g. changes in electrodermal and gastric activity).
In our study we aim to test the following hypotheses:
- Placebo administration leads to a significant changes of blood pressure compared with untreated controls.
- The direction of blood pressure change depends on the type of suggestion (either decrease or increase)
- This effect is specific for blood pressure; changes in electrodermal and gastric activity do not differ between groups.
- The placebo response can be enhanced by a prestige intervention (information about the suggested drug action given by doctor or in written form).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
排除标准
- •Not meeting inclusion criteria
- •Untreated hypertension (BP > 140/90) or hypotension(BP < 100/60)
- •Severe systemic disorders (tumors, tbc, diabetes, asthma etc)
- •Diseases with influence on cardiovascular or gastrointestinal system
- •Pregnancy and lactation phase
- •Body mass index > 30
- •Regular intake of drugs with influence on the autonomic nervous system
- •Insufficient compliance
- •Simultaneous participation in another trial
结局指标
主要结局
Mean arterial pressure
时间窗: 60 minutes
次要结局
- Heart rate(60 minutes)
- skin conductance level(60 minutes)
- gastric activity(60 minutes)
