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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02578212
Other study ID # EKNZ 2014-396
Secondary ID
Status Completed
Phase N/A
First received October 12, 2015
Last updated April 7, 2016
Start date January 2015
Est. completion date March 2016

Study information

Verified date April 2016
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
Placebo


Locations

Country Name City State
Switzerland University of Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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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