Pain Clinical Trial
Official title:
Back to Basics - Effects, Narratives and Routes of Administration of Open-label Placebo
Verified date | July 2017 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To date, very little is known about the mechanisms of open-label placebo treatment and there is a lack in highly controlled experimental designs. Therefore, the planned project will test well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning response, in an open-label placebo design, investigating their influence on placebo analgesia.
Status | Completed |
Enrollment | 160 |
Est. completion date | June 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Healthy male and female adults aged 18-65 - 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: - Medicine or Psychology Students - 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.) |
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 | subjective intensity and unpleasantness ratings of heat pain tolerance | Visual Analogue Scale (VAS) | 2 hours | |
Primary | objective heat pain tolerance | Temperatures | 2 hours | |
Secondary | Expectancy of Relief Scale (ERS; Erwartungsfragebogen) | 2 hours | ||
Secondary | Credibility and Effectiveness of the placebo analgesia expectation; adapted Version of the Context Model Questionnaire; Kontextmodellfragebogen (KMF) | 2 hours | ||
Secondary | multidimensional sensitivities questionnaire (Mehrdimensionaler Befindlichkeitsfragebogen (MDBF)) | 2 hours | ||
Secondary | sociodemographic questionnaire (Soziodemographischer Fragebogen (SDD)) | 2 hours | ||
Secondary | Revised Life Orientation Test (LOT-R) | 2 hours | ||
Secondary | NEO five-factor inventory (NEO-FFI) | 2 hours | ||
Secondary | questionnaire on competence and locus of control (Fragebogen zu Kompetenz- und Kontrollüberzeugungen (FKK)) | 2 hours | ||
Secondary | Anxiety and Depression Scale (HADS-D) | 2 hours | ||
Secondary | Beliefs in holistic health and holistic treatments; Complementary and Alternative Medicine Beliefs Intentory (CAMBI) | 2 hours | ||
Secondary | Desire for Relief Scale (DRS) | 2 hours | ||
Secondary | subjective intensity and unpleasantness ratings of heat pain threshold | Visual Analogue Scale (VAS) | 2 hours | |
Secondary | objective heat pain threshold | Temperatures | 2 hours |
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