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Nocebo effects on pressure pain

Inducing and reducing nocebo effects on pressure pain via learning

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23815
Enrollment
124
Registered
2019-09-17
Start date
2018-12-19
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

The study is conducted in a sample of healthy volunteers.

Interventions

Open-label verbal suggestions about a placebo TENS device and open-label conditioning to induce and reduce nocebo effects on pressure pain, in the form of nocebo conditioning, continued nocebo conditi

Sponsors

Leiden University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy female volunteers between 18 and 35 years old, with a good understanding of written and spoken Dutch.

Exclusion criteria

Exclusion criteria: Severe somatic or psychiatric morbidity (e.g., heart/lung diseases, DSM-V psychiatric disorders), Raynaud’s disease, chronic pain complaints at present or in the past, current pain complaints, current use of medication, injuries on the non-dominant hand, refusal/inability to remove nail polish or artificial nails for the experiment, pregnancy, color-blindness.

Design outcomes

Primary

MeasureTime frame
The change in nocebo effect from after nocebo conditioning (part 1) to after counterconditioning, extinction, and continued nocebo conditioning (part 2) will be compared across groups. Nocebo effects will be calculated by taking the mean difference of pain ratings during experimental trials (placebo TENS device activation) versus pain ratings during control trials (placebo TENS device deactivation) in the test phase.

Secondary

MeasureTime frame
The comparison of the induction of nocebo effects after nocebo conditioning and sham conditioning. The mean difference between self-reported pain ratings during experimental and control trials of the testing phase (i.e., nocebo effects) will be calculated for nocebo conditioning and sham conditioning groups, and then compared.

Contacts

Public ContactAndrea Evers

Leiden University

a.evers@fsw.leidenuniv.nl+31 71 527 6891

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)