Skip to content

Positive and negative treatment expectations and their effects on placebo analgesia and nocebo hyperalgesia, and their stability over time

Positive and negative treatment expectations and their effects on placebo analgesia and nocebo hyperalgesia, and their stability over time - COLA

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00029228
Enrollment
100
Registered
2022-06-09
Start date
2022-06-04
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

pain perception healthy participants

Interventions

Group 1: healthy subjects to receive heat pain stimuli in all 3 experimental conditions (within-subject design)

Sponsors

Universitätsklinikum EssenKlinik für Neurologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Age: 18-40 years, consent to study, fluent German skills, healthy

Exclusion criteria

Exclusion criteria: Alcohol consumption one day before trial day 2 and/or 3; Alcohol consumption on trial day 1-3; Substance/drug use in the last 4 weeks; Medication use in the last 7 days (except hormonal contraceptives); Use of anticoagulant or pain medications in the last 24 hours; Known neurological, internal, psychological, as well as skin and cold-associated diseases; Allergies (contact allergies); Participation in an electrostimulation or heat stimulation study in the last 6 months; Color blindness or red-green deficiency; Surgical procedures in the last 6 months; Injuries/scars on the forearms; Skin damage (e.g. sunburn) on the forearms; Limited visual acuity or uncorrected visual acuity; Restricted hearing; Acute infections

Design outcomes

Primary

MeasureTime frame
The extent of placebo analgesia and nocebo hyperalgesia (difference in subjective pain intensity as an interaction between the experimental condition (placebo vs. nocebo vs. control) on the day of the conditioning phase.

Secondary

MeasureTime frame
The extent of placebo analgesia and nocebo hyperalgesia one week after the conditioning phase; The expectation of pain intensity on the day of conditioning and one week later compared to baseline (before conditioning); Exploratory outcome measures are treatment experience and tolerability, genetic predispositions (saliva sample), tolerability and side effects on day 1, 2 and 8 (GASE), psychometric predictors (prior experience with placebo treatment, somatosensory amplification (Somatosensory Amplification Scale, SSAS), perceived stress (Perceived Stress Scale, PSS), Anxiety and depression as a state (State)/current state (State-Trait-Anxiety-Depression Inventory, STADI State), Anxiety and depression as a trait (Trait)/general state anxiety and depression (STADI Trait), Fear of pain (Fear of Pain Questionnaire-III (FPQ-III)), Catastrophizing thoughts related to pain (Pain Catastrophizing Scale, PCS), Personality factors (10-item Big Five Inventory)).

Countries

Germany

Contacts

Public ContactAngelika Kunkel

Universitätsklinikum EssenKlinik für Neurologie

angelika.kunkel@uk-essen.de004920172326467

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026