Pain perception Healthy volunteers
Conditions
Interventions
Group 1: Nocebo instruction with Sham Naloxone Infusion and pharmacological modulation with midazolam 2mg
Group 2: Nocebo instruction with Sham Naloxone Infusion without pharmacological modulation wi
Sponsors
Universitätsklinikum Essen
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Age =18 Jahre, Weight 50-100kg, Consent and fluent German skills, healthy
Exclusion criteria
Exclusion criteria: Any drug or alcohol abusus, chronic or acute pain conditions or diseases, severe depression, epilepsy, diabetes, schizophrenia, suicidality, hypersensitivity or allergies against study medication, participation to other studies with study medication or methods within the last 3 months, use of beta blockers, benzodiazepins, corticosteroids, hormonal contraceptives, working in night shift
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of pain-related anxiety on negative treatment expectations and hyperalgesia (Pain: Visual Analogue Scale as Area under the Curve (AUC); Anxiety: Visual Analogue Scale from 0 to 100 during the measurements with cold water bath at the second time of measurement in comparison to baseline measurement) | — |
Secondary
| Measure | Time frame |
|---|---|
| Extent of nocebo hyperalgesia(difference between subjective pain ratings between baseline measurements and test phase), pharmacokinetics of Midazolam, temporal dynamics of salivary stress markers (salivary alpha amylase and cortisol) with cold pressor test, perceived pain-related stress (Stress Visual Analogue Scale), pain-related and general state anxiety (Visual Analogue Scale), pain perception as well as tolerability, credibility and side effects of the test(Generic Assessment of Side Effects, GASE). Explorative outcomes are psychological and personality parameters (somatosensory amplification (Somatosensory Amplification Scale, SSAS), perceived stress (Perceived Stress Scale, PSS), chronic stress (Trier Inventory for Chronic Stress, TICS), state and trait anxiety and depression (State-Trait-Angst-Depressions-Inventar, STADI State), fear of pain (Fear of Pain Questionnaire - III, FPQ-III), catastrophising thinking related to pain (Pain Catastrophizing Scale, PCS), personality factors (10 item Big Five Inventory (BFI-10) and Behavioral Inhibition System Behavioral Approach System (BISBAS), previous treatment experiences, treatment expectations, and treatment effects (Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects GEEE)), general impression of the experimenter to the subjects (Wärme und Kompetenz). | — |
Countries
Germany
Contacts
Public ContactAngelika Kunkel
Universitätsklinikum Essen
Outcome results
None listed