Do open label placebos induce placebo analgesia in a pain conditioning paradigm?
- Conditions
- Pain
- Registration Number
- NL-OMON23347
- Lead Sponsor
- eiden university
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 96
Healthy male and female volunteers from age 16 – 35 years. Participants have a good understanding in speaking and understanding English.
Refusal to give written informed consent, severe morbidity (e.g. multiple sclerosis, heart and lung disease), suffering or have suffered from pain lasting for = 6 months, serious neurological or psychiatric conditions, regular use of recreational drugs, current use of analgesic medication, substance abuse, injuries on arms or hands, colour-blindness, pregnancy or lactation and previous participation in similar previous heat pain experiments (‘Aan de slag met pijn’ and ‘Generalization Study’). Exclusion criteria will be stated on the online research platform (SONA) where participants can apply for the experiment and will be assessed by asking the participants before the start of the screening phase whether they experience any of the abovementioned symptoms.
Participants that report high pain thresholds during the screening phase (see: Calibration) will also be excluded from the study. Participants will be asked to withhold from alcohol consumption 24 hours prior to the experiment, and caffeine and nicotine 3 hours prior the experiment. Recreational drug use is not permitted one week before participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Placebo effects (VAS scores between first yellow and first purple cues) compared between the open label placebo group and the control group. Mean VAS scores of all three yellow versus purple cues will also be compared.
- Secondary Outcome Measures
Name Time Method Placebo effects (VAS scores between first yellow and first purple cues) compared between the open label placebo group and the deceptive placebo group. Mean VAS scores of all three yellow versus purple cues will also be compared.<br>For exploratory purposes we will also investigate the role of demographics, anxiety and optimism as predictors for the magnitude of placebo effects with linear regression analyses. <br>