Effects of tactile stimulation on the placebo response in a nausea-inducing model
- Conditions
- Healthy volunteers
- Registration Number
- DRKS00015192
- Lead Sponsor
- MU München, Institut für Medizinische Psychologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 104
right-handed;
normal or corrected-to-normal vision and hearing;
body-mass index between 18 and 25 kg/m2;
written informed consent.
Implanted devices (e.g., pacemaker, insulin pump) or metal implants;
History of diseases of the inner ear (e.g., Morbus Menière, acute hearing loss);
History of blood-clotting disorders or tendency for thromboembolic diseases;
History of neurological or psychiatric disease;
Any chronic somatic or psychiatric disease, especially skin diseases, diabetes, cardiovascular disease, epilepsy, cancer;
Regular intake of any medication except for hormonal contraceptives, thyroid medications, allergy medications ;
Surgery during the past 4 weeks;
Acute disease (e.g., cough, influenza);
Inability to imply with the specific instructions;
Alcohol or drug abuse;
Current pregnancy or breast feeding;
Prior participation in placebo or nocebo study;
Anxiety or depression scores above the clinically relevant cut-off, as assessed with the Hospital Anxiety and Depression Scale (HADS);
Motion sickness score below 50 (according to the Motion Sickness Susceptibility Questionnaire; MSSQ);
Report of less than moderate nausea (<5 on the NRS) in the pre-test session.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Baseline-corrected change in acute nausea, measured on an 11-point numerical rating scale, from day 1 (control day) to day 2 (test day) for placebo group 1 vs. placebo group 2 (differential placebo effect) as well as for placebo groups 1/2 vs. no treatment (placebo effect).
- Secondary Outcome Measures
Name Time Method Changes in dizziness (NRS), vection (NRS), subjective stress (NRS), motion sickness (symptom score), normo-to-tachy ratio in the electrogastrogram, delta-activity at C3 and C4 in the EEG, heart rate, salivary cortisol, salivary alpha-amylase, plasma ghrelin. In an explorative approach, proteomics analyses (blood plasma) and eLORETA analyses of the EEG will be performed. Treatment expectations are analyzed prospectively and retrospectively.