An interventional study of open-label placebo and deceptive placebo in Placebo Effect, Pain and Expectancy, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-26.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Basic science
To date, very little is known about the mechanisms of open-label placebo treatment and there is a lack in highly controlled experimental designs. Therefore, the planned project will test well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning response, in an open-label placebo design, investigating their influence on placebo analgesia.
The current project will consist of one experimental study and one qualitative study:
The experimental study will be a randomized experiment with healthy subjects (N=120), and pain will be induced using a standardized heat pain paradigm (Medoc, Ramatishai, Israel; thermo-sensory analyzer (TSA)-II). Effects of the experimental conditions will be assessed both objectively (i.e. heat pain threshold and tolerance) and subjectively (i.e. subjective pain ratings, pain intensity and unpleasantness). Furthermore, investigators will randomly select 30 participants to take part in a nested qualitative study in order to qualitatively assess the meaning response by comparing subjective narratives of the placebo effect in the open-label and deceptive placebo groups, as well as in the control group.
University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants (N=40) will have the information that they are receiving an inert cream (i.e. "placebo"). Placebo will be described as an inert or inactive cream, with no medication in it. Additionally, participants will be told that "placebo has been shown in rigorous clinical testing to produce significant mind-body self-healing processes." The placebo administration will be combined with the following scientific rationale/verbal suggestion: (a) placebos are effective analgesics, (b) classical conditioning as a possible mechanism of this effect, (c) compliance is important for outcome and (d) positive expectations increase placebo effects, but are not necessary.
Other: open-label placebo
Participants (N=40) will have the information that they are receiving an analgesic cream ("Antidolor, containing "Lidocain"), while in fact they will receive an inert cream, only. Antidolor will be described as an analgesic cream.
Other: deceptive placebo
Participants (N=40) will have the information that they are receiving an inert control cream.
Other: open-label placebo
Participants (N=40) will be told that they are in the "no treatment group" and that they will not receive an analgesic cream.
Placebo Cream, openly described as "Placebo"
Placebo Cream, described as "Voltaren, containing Diclofenac"
subjective intensity and unpleasantness ratings of heat pain tolerance
Visual Analogue Scale (VAS)
Time frame: 2 hours
objective heat pain tolerance
Temperatures
Time frame: 2 hours
Expectancy of Relief Scale (ERS; Erwartungsfragebogen)
Time frame: 2 hours
Credibility and Effectiveness of the placebo analgesia expectation; adapted Version of the Context Model Questionnaire; Kontextmodellfragebogen (KMF)
Time frame: 2 hours
multidimensional sensitivities questionnaire (Mehrdimensionaler Befindlichkeitsfragebogen (MDBF))
Time frame: 2 hours
sociodemographic questionnaire (Soziodemographischer Fragebogen (SDD))
Time frame: 2 hours
Revised Life Orientation Test (LOT-R)
Time frame: 2 hours
NEO five-factor inventory (NEO-FFI)
Time frame: 2 hours
questionnaire on competence and locus of control (Fragebogen zu Kompetenz- und Kontrollüberzeugungen (FKK))
Time frame: 2 hours
Anxiety and Depression Scale (HADS-D)
Time frame: 2 hours
Beliefs in holistic health and holistic treatments; Complementary and Alternative Medicine Beliefs Intentory (CAMBI)
Time frame: 2 hours
Desire for Relief Scale (DRS)
Time frame: 2 hours
subjective intensity and unpleasantness ratings of heat pain threshold
Visual Analogue Scale (VAS)
Time frame: 2 hours
objective heat pain threshold
Temperatures
Time frame: 2 hours
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Basel, Switzerland