Trust Game and Placebo Response

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT02578212

Collaborator

(none)

106

Enrollment

Location

Arms

Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Placebo Effect Pain Trust	Other: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Trust Game and Placebo Response

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Visual analogue scale (VAS) rating (Intensity + unpleasantness of pain) [2 hours]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Basel	Basel		Switzerland	4055

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Investigators

Study Chair: Jens Gaab, Prof, Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT02578212

Other Study ID Numbers:

EKNZ 2014-396

First Posted:

Oct 16, 2015

Last Update Posted:

Apr 8, 2016

Last Verified:

Apr 1, 2016

Study Results

No Results Posted as of Apr 8, 2016