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Predictive factors of the impact of expectation- and experience-effects on therapy outcomes.

Predictive factors of the impact of expectation- and experience-effects on therapy outcomes. - PFEET

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017036
Enrollment
850
Registered
2019-03-28
Start date
2013-03-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers

Interventions

Group 1: Healthy volunteers are being examined for pain modulation using heat stimuli for a placebo and nocebo paradigm. In addition, saliva samples are collected for genotyping, a large questionnaire

Sponsors

Institut für Systemische NeurowissenschaftenUniversitätsklinikum Hamburg-Eppendorf
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Healthy 2. 18 - 35 years old 3. Speak and read fluent German 4. "Caucasians" (polymorphisms are often distributed differently in populations of different origins) 5. The average alcohol consumption is less than 15 glasses (wine, beer or similar, 1 glass of higher percentage alcohol counts like 2 glasses) per week. 6. The average cigarette consumption is less than 20 cigarettes a day. 7. Except for occasional cannabis use (no more than once a month on average), no illegal drugs are consumed.

Exclusion criteria

Exclusion criteria: 1. Serious diseases of: · Brain or mind (including anxiety disorders, depression, schizophrenia, alcohol, drug or drug dependence, neurological disorders other than occasional headache) · Heart or circulation (including arterial hypertension from hypertension grade I) · Blood · Lungs · Liver · Kidneys · Thyroid · Eyes (including glaucoma, color blindness and myopia of more than -5 diopters) · Skin · Gastrointestinal tract · Metabolism. It does not matter whether the disease is treated or untreated, whether it was long-term, short-term or long ago. Exceptions are former childhood diseases and former harmless diseases such as usual gastrointestinal infections, stress headache, common colds, etc. If in doubt, the examiner decides. 2. Cancer 3. Current medication and medication in a period of 2 months before genotyping. Medication also refers to the use of medication during a clinical examination as well as the regular intake of sleeping pills. Only over-the-counter medicines are excluded if intake of the medication is terminated more than 1 week before study participation. It remains at the discretion of the investigator to include participants with current or past medication in the study if the drug in question should not have any expected effect on the study. 4. Other serious health problems or current severe mental or physical stress.

Design outcomes

Primary

MeasureTime frame
The volunteer rates heat stimulation on a visual analogue scale ranging from 0 to 100. 0 indicates "no pain", 100 indicates "unbearable pain". The visual analogue scale is presented on a computer screen and the volunteer can select the right value for him by means of a keyboard. There are eight heat stimuli per condition, each of which is rated, and an average is created from these eight assessments. The conditions are: Control 1, unconditioned placebo, control 2, conditioning placebo, control 3, conditioned placebo, control 4, unconditioned nocebo, control 5, conditioning Nocebo, control 6, conditioned nocebo Altogether there are 96 assessments from which 12 averages are formed, which are used for the analysis of the study.

Countries

Germany

Contacts

Public ContactMari Feldhaus

Institut für Systemische NeurowissenschaftenUniversitätsklinikum Hamburg-Eppendorf

m.feldhaus@uke.de+49-40-7410-57882

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026