Healthy volunteers of all sex/gender between 18-65 years of age
Conditions
Interventions
Group 1: - Experimental visceral and somatic pain stimuli (rectal distensions, cutaneous thermal pain on the lower abdomen) within treatment context
- Sad mood induction
- Positive learning experience
Sponsors
Universitätsklinikum Essen, Klinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: fluent in German, BMI 18-30
Exclusion criteria
Exclusion criteria: - Acute and chronic physical illnesses (e.g., pain disorders, gastrointestinal diseases, cardiovascular diseases) - Regular use of medication (except hormon or thyroid replacement; allergy medications) - Indications of psychiatric disorders based on validated screening instruments (especially depression and anxiety disorders) and/or self-report - MRI-specific exclusion criteria (anxiety disorders, especially claustrophobia, metallic implants, metal-containing tattoos, etc.) - Additional exclusion criterion: Indication of anorectal abnormalities (e.g., hemorrhoids), identified during screening or medical examination (including digital rectal exam) prior to placement of the rectal balloon catheter for pressure-controlled rectal distension as an established visceral pain model - Additional exclusion criterion for female participants: Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain perception based on VAS ratings of intensity and unpleasantness of visceral and somatic pain stimuli after the first treatment phase (compared to baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in modality-specific, pain-related expectation of pain intensity and unpleasantness based on VAS ratings after the first treatment phase (compared to baseline) - Change in modality-specific, pain-related fear based on VAS ratings after the first treatment phase (compared to baseline) - Differences in treatment expectations regarding the pharmacological intervention (G-EEE Expectations) before the first treatment phase - Differences in overall subjective treatment experience (G-EEE Current Effects) as well as in modality-specific perceived effectiveness of the treatment based on VAS ratings after the first treatment phase Exploratory variables: - Change in mood (STADI State; VAS current sadness) after the first treatment phase (compared to baseline) - Expected and experienced side effects of the treatment (GASE; G-EEE Expectations, Side Effects subscale; G-EEE Current Effects, Side Effects subscale) before and after the first treatment phase, respectively - Changes in the desire to avoid pain, based on VAS ratings of the wish to avoid visceral and somatic pain stimuli in the future after the first treatment phase (compared to baseline) - Differences in the overall desire for pain relief through treatment based on VAS ratings before and after the first treatment phase - Recall of the pain area for each pain modality (body sketch) after the first treatment phase - Changes in salivary cortisol and alpha-amylase concentrations over the course of treatment - Changes in psychophysiological parameters (continuously recorded during pain stimulation phases) over the course of treatment: skin conductance (electrodermal activity), heart rate/heart rate variability (electrocardiography), gastric myoelectrical activity (electrogastrography), respiratory rate - Perceived warmth and competence of the study physician (questionnaire) after treatment - Changes in primary, secondary, and exploratory (if applicable) endpoints after the second treatment phase com | — |
Countries
Germany
Contacts
Public ContactSigrid Elsenbruch
Universitätsklinikum Essen, Klinik für Neurologie
Outcome results
None listed