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Expectancies and pain modulation

Which factors influence pain modulation?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON19877
Enrollment
114
Registered
2017-11-01
Start date
2017-03-01
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, expectations

Interventions

Positive outcome expectations will be induced by verbal suggestions. Participants will be told that they will experience either less or more pain or receive no instruction (the nature of the instructi

Sponsors

Leiden University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy male and female participants 2. Between 18 and 35 years old 3. Good understanding of written and spoken Dutch

Exclusion criteria

Exclusion criteria: 1. Refusal to provide written informed consent 2. Severe somatic or psychological morbidity (e.g. cardiovascular diseases, chronic pain or DSM-V psychiatric disorders) that would adversely affect participant’s safety or that might interfere with the study protocol 3. Substance abuse 4. Problems with hearing or vision 5. Recent injury to body parts to be tested (hands, arms) 6. Current pain complaints 7. Recent use of medication 8. Raynaud syndrome 9. Pregnancy

Design outcomes

Primary

MeasureTime frame
The primary study outcome is the difference in pressure pain thresholds (which will be determined by averaging 3 pressure pain threshold determinations following validated protocols) in combination with the cold pressor test compared to the determination without the cold pressor test. These difference scores will be compared between the three groups: a analgesia group in which participants receive positive verbal suggestions, a hyperalgesia group in which participants receive negative verbal suggestions and a control group in which participants receive no verbal suggestions.

Secondary

MeasureTime frame
Secondary analyses will be conducted to examine sex differences in the role of expectations on CPM, the relationship between CPM and cognitive inhibition, and the effects of expectancy manipulation on other outcome parameters (e.g., pain ratings, psychophysiological assessments of heart rate and skin conductance levels and subjective stress). Pain and subjective stress levels will be assessed using 0-10 cm visual analog scales. In addition, the possible influence of psychological parameters on outcomes will be explored.

Contacts

Public ContactDieuwke S. (Judy) Veldhuijzen
d.s.veldhuijzen@fsw.leidenuniv.nl+31 71 527 3902

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)