Healthy volunteers
Conditions
Interventions
Group 1: Nausea is experimentally generated in healthy volunteers on two separate days by means of visual stimulation. On the second day, participants will be randomly assigned to one of 4 treatment a
Sponsors
LMU München, Institut für Medizinische Psychologie
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: right-handed; normal or corrected-to-normal vision and hearing; body-mass index between 18 and 25 kg/m2; written informed consent.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Germany
Contacts
Public ContactAnja Haile
Institut für Medizinische Psychologie, LMU München
Outcome results
None listed