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Trial record 25 of 34017 for:    Placebo AND placebo effect

Trust Game and Placebo Response

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ClinicalTrials.gov Identifier: NCT02578212
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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



Primary Outcome Measures :
  1. Visual analogue scale (VAS) rating (Intensity + unpleasantness of pain) [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Visual analogue scale (VAS) rating (trust) [ Time Frame: 2 hours ]
  2. State-Trait-Anxiety (STAI- X1) [ Time Frame: 2 hours ]
  3. State Trait Anger Expression (STAXI) [ Time Frame: 2 hours ]
  4. Questionnaire about expectations (Erwartungsfragebogen) [ Time Frame: 2 hours ]
  5. Questionnaire about the investigator (Fragebogen zum Versuchsleiter [ Time Frame: 2 hours ]
  6. sociodemographic questionnaire (Soziodemographischer Fragebogen (SES)) [ Time Frame: 2 hours ]
  7. Questionnaire about Self-assessment of partnership binding (Bochumer Bindungsfragebogen - BoBi) [ Time Frame: 2 hours ]
  8. State-Trait-Anxiety (STAI-X2 ) [ Time Frame: 2 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02578212


Locations
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Switzerland
University of Basel
Basel, Switzerland, 4055
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Jens Gaab, Prof Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02578212     History of Changes
Other Study ID Numbers: EKNZ 2014-396
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016