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: 1. Placebo administration leads to a significant changes of blood pressure compared with untreated controls. 2. The direction of blood pressure change depends on the type of suggestion (either decrease or increase) 3. This effect is specific for blood pressure; changes in electrodermal and gastric activity do not differ between groups. 4. The placebo response can be enhanced by a prestige intervention (information about the suggested drug action given by doctor or in written form).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
90
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects in written form.
Placebo administration with a blood pressure decrease suggestion. Information provided to subjects by doctor.
Placebo administration with a blood pressure increase suggestion. Information provided to subjects in written form.
Placebo administration with a blood pressure increase suggestion. Information provided to subjects by doctor.
Subject informed about receiving placebo. Information provided to subjects in written form.
Subject informed about receiving placebo. Information provided to subjects by doctor.
Department of Psychosomatic Medicine and Psychotherapy, Charité University
Berlin, Germany
RECRUITINGMean arterial pressure
Time frame: 60 minutes
Heart rate
Time frame: 60 minutes
skin conductance level
Time frame: 60 minutes
gastric activity
Time frame: 60 minutes
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