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Do open label placebos induce placebo analgesia in a pain conditioning paradigm?

Do open label placebos induce placebo analgesia in a pain conditioning paradigm?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23347
Enrollment
96
Registered
2019-12-10
Start date
2019-10-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Interventions

Healthy participants will undergo a thermal heat pain procedures in which a series of short heat stimuli are administered. During the calibration phase, individual pain thresholds are assessed for low

Sponsors

Leiden university
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male and female volunteers from age 16 – 35 years. Participants have a good understanding in speaking and understanding English.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 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.

Contacts

Public ContactRosanne Smits

Universiteit Leiden

r.m.smits@fsw.leidenuniv.nl0634032283

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)