Trust Game and Placebo Response

NCT02578212 | Completed

• 1 other identifier: EKNZ 2014-396
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Placebo Effect; Pain; Trust

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS) rating (Intensity + unpleasantness of pain)

  2 hours

Secondary Outcomes (8)

• 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

Study Arms (2)

Control

PLACEBO COMPARATOR

All participants will also be introduced to the control cream: "This cream is a control cream".

Other: Placebo

Placebo

SHAM COMPARATOR

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

Interventions

Placebo OTHER

Control; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University of Basel

Basel, 4055, Switzerland

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens Gaab, Prof

  Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 16, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 8, 2016

Record last verified: 2016-04

Locations

CH (1)