Trust Game and Placebo Response

Pain Clinical Trial

Official title:

Trust Game and Placebo Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578212
• Other study ID #: EKNZ 2014-396
• 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

• Pain
• Placebo Effect
• Trust

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