Pain Clinical Trial
Official title:
Trust Game and Placebo Response
Verified date | April 2016 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
In the proposed study, investigators aim to investigate the role of interpersonal trust in the conditioned placebo analgesia process with healthy male subjects in a standardized experimental heat pain paradigm.
Status | Completed |
Enrollment | 106 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Men: age between 18 and 40 years old - Healthy by self-report statement, thus no known current or chronic somatic diseases or psychiatric disorders - Right-handedness (Oldfield, 1971) - Willing to participate in study Exclusion Criteria: - Any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes) as well as skin pathologies, neuropathies or nerve entrapment symptoms, sensory abnormalities affecting the tactile or thermal modality - Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment - Insufficient German language skills to understand the instructions - Previous participation in studies using pain assessment (threshold and tolerance) with Peltier Devices - Daily consumption of more than three alcoholic standard beverages per day (a standard alcoholic beverage is defined as either 3dl beer or 1 dl wine or 2cl spirits - Current or regular drug consumption (THC, cocaine, heroin, etc.) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Switzerland | University of Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual analogue scale (VAS) rating (Intensity + unpleasantness of pain) | 2 hours | No | |
Secondary | Visual analogue scale (VAS) rating (trust) | 2 hours | No | |
Secondary | State-Trait-Anxiety (STAI- X1) | 2 hours | No | |
Secondary | State Trait Anger Expression (STAXI) | 2 hours | No | |
Secondary | Questionnaire about expectations (Erwartungsfragebogen) | 2 hours | No | |
Secondary | Questionnaire about the investigator (Fragebogen zum Versuchsleiter | 2 hours | No | |
Secondary | sociodemographic questionnaire (Soziodemographischer Fragebogen (SES)) | 2 hours | No | |
Secondary | Questionnaire about Self-assessment of partnership binding (Bochumer Bindungsfragebogen - BoBi) | 2 hours | No | |
Secondary | State-Trait-Anxiety (STAI-X2 ) | 2 hours | No |
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