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Trust Game and Placebo Response

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University Hospital Basel

Status

Completed

Conditions

Trust
Pain
Placebo Effect

Treatments

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02578212
EKNZ 2014-396

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.)

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

106 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
All participants will also be introduced to the control cream: "This cream is a control cream".
Treatment:
Other: Placebo
Placebo
Sham Comparator group
Description:
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.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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