Trust Game and Placebo Response

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 Overview

• Status: Completed
• Conditions: Pain; Placebo Effect; Trust
• Intervention / Treatment: Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4055
    • University of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; All participants will also be introduced to the control cream: "This cream is a control cream".	Other: Placebo
Sham Comparator: Placebo; All participants will then be introduced to an analgesia expectation: "This cream is a powerful pain killer", while receiving an inert cream. In this study participants will be told that they will receive a potent painkiller as well as a control cream. Making use of placebo cream is an established method to induce placebo expectations . Moreover, to increase the analgesic effect, heat pain stimuli intensity will be surreptitiously lowered for the placebo trials to a temperature corresponding to 30% of the VAS intensity and to 60% for the control trials. As the occurrence of a placebo response is highly dependent on expectations, the deceptive procedure described above is used in order to maximally enhance expectations and therefore placebo response. Participants will be debriefed after the completion of study participation.	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual analogue scale (VAS) rating (Intensity + unpleasantness of pain)	2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Jens Gaab, Prof, Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Estimate): April 8, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: EKNZ 2014-396