Effects of negative expectation on visceroception and visceral pai
Not Applicable
- Conditions
- healthy male and female volunteers
- Registration Number
- DRKS00024410
- Lead Sponsor
- niversitätsklinikum Essen, Klinik für Neurologie, Translational Pain Research Unit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 149
Inclusion Criteria
Fluent in German, BMI 18-30
Exclusion Criteria
Acute and chronic health conditions, especially chronic pain, gastrointestinal conditions, mental disorders, cardiovascular conditions. Regular medication intake. Any evidence suggesting psychiatric conditions based on self-report and during screening with validated instruments. MRI-specific exclusion criteria (metal implants, claustrophobia, etc.); any evidence of anorectal changes upon screening and physical examination that would interfere with rectal distensions. In women: pregancy, breastfeeding, oral hormonal contraceptives
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain perception (intensity, unpleasantness) assessed with visual analogue scales, pain-related fear and avoidance, treatment expectations and expected side effects (validated questionaires: GASE; GEEE)
- Secondary Outcome Measures
Name Time Method Repeated assessements of psychologial parameters before and after each pain stimulation series: State anxiety (STADI), pain- and stress-relevant neuroendocrine and immune markers, especially cortisol and alpha-amylase, in saliva and blood; psychophysiological responses (skin conductance, heart rate) to pain-predictive cues and pain stimuli. Measures assessing aspects of the doctor-patient relashionship and pain-related memory aspects with rating skales. Psychological traits assessed prior to the study (questionnaire battery assessing personality, pain, coping, etc). Resting state fMRI and DTI, cortisol awakening response prior to the study as part of the central CRC projects; microbiome in stool samples.