NCT02578212CompletedNot Applicable
Trust Game and Placebo Response
University Hospital, Basel, Switzerland2 sites in 1 country106 target enrollmentStarted: January 1, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 106
- Locations
- 2
- Primary Endpoint
- Visual analogue scale (VAS) rating (Intensity + unpleasantness of pain)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.)
Outcomes
Primary Outcomes
Visual analogue scale (VAS) rating (Intensity + unpleasantness of pain)
Time Frame: 2 hours
Secondary Outcomes
- Visual analogue scale (VAS) rating (trust)(2 hours)
- State-Trait-Anxiety (STAI- X1)(2 hours)
- State Trait Anger Expression (STAXI)(2 hours)
- Questionnaire about expectations (Erwartungsfragebogen)(2 hours)
- Questionnaire about the investigator (Fragebogen zum Versuchsleiter(2 hours)
- sociodemographic questionnaire (Soziodemographischer Fragebogen (SES))(2 hours)
- Questionnaire about Self-assessment of partnership binding (Bochumer Bindungsfragebogen - BoBi)(2 hours)
- State-Trait-Anxiety (STAI-X2 )(2 hours)
Investigators
Study Sites (2)
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