Placebo EffectNCT02578212
Trust Game and Placebo Response
A study of Placebo Effect and Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Placebo Effect, Pain, Trust
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | All participants will also be introduced to the control cream: "This cream is a control cream". Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) rating (Intensity + unpleasantness of pain)
Measured: 2 hours
Secondary outcomes (8)
Visual analogue scale (VAS) rating (trust)
Measured: 2 hours
State-Trait-Anxiety (STAI- X1)
Measured: 2 hours
State Trait Anger Expression (STAXI)
Measured: 2 hours
Questionnaire about expectations (Erwartungsfragebogen)
Measured: 2 hours
Questionnaire about the investigator (Fragebogen zum Versuchsleiter
Measured: 2 hours
sociodemographic questionnaire (Soziodemographischer Fragebogen (SES))
Measured: 2 hours
Questionnaire about Self-assessment of partnership binding (Bochumer Bindungsfragebogen - BoBi)
Measured: 2 hours
State-Trait-Anxiety (STAI-X2 )
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placebo EffectStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Gaab, Prof, Study chair, Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578212
- Sponsor's protocol ID
- EKNZ 2014-396
- Status last verified
- Apr 2016
- First submitted
- 12 Oct 2015
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trust Game and Placebo Response
- ClinicalTrials.gov ID
- NCT02578212
- Acronym / sponsor ID
- EKNZ 2014-396
- Conditions
- Placebo Effect, Pain, Trust
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboAll participants will also be introduced to the control cream: "This cream is a control cream". |
| Placebo | Sham comparator | Other: PlaceboAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Other | Control, Placebo |
Primary outcome
Visual analogue scale (VAS) rating (Intensity + unpleasantness of pain)
Time frame: 2 hours
8 secondary outcomes
Visual analogue scale (VAS) rating (trust)
Time frame: 2 hours
State-Trait-Anxiety (STAI- X1)
Time frame: 2 hours
State Trait Anger Expression (STAXI)
Time frame: 2 hours
Questionnaire about expectations (Erwartungsfragebogen)
Time frame: 2 hours
Questionnaire about the investigator (Fragebogen zum Versuchsleiter
Time frame: 2 hours
sociodemographic questionnaire (Soziodemographischer Fragebogen (SES))
Time frame: 2 hours
Questionnaire about Self-assessment of partnership binding (Bochumer Bindungsfragebogen - BoBi)
Time frame: 2 hours
State-Trait-Anxiety (STAI-X2 )
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Gaab, Prof study chair
Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Placebo Effect and Pain, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (VAS) rating (Intensity + unpleasantness of pain) (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2016; AzTrials last refreshed its copy on 4 Nov 2026.