Pain-related Fear as a Facilitator of Nocebo Hyperalgesia
CompletedNot applicableNCT04197154
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Nocebo hyperalgesia is characterized by adverse pain outcomes, induced by patients' expectations. In the lab, nocebo effects are commonly studied via classical conditioning, a method that employs pairings of neutral cues/treatments with different pain intensities to install differential pain-related expectations. In such conditioning experiments, participants are typically taught that a (sham) treatment exaggerates their pain, by surreptitiously administering high intensity (e.g. pain) stimuli in combination with this treatment. Verbal suggestions are also often used to inform participants of the supposed adverse effects of such treatments. In nocebo studies, higher pain levels and suggestions that are of more threatening nature may induce fear, thereby adding a crucial element to the experimental manipulation. Since nocebo effects are hypothesized to arise in clinical settings due to a combination of several psychological and cognitive mechanisms, it is important to study the role that factors such as higher pain levels, conditioned pain-related fear, or more threatening verbal suggestions may play in the formation of nocebo hyperalgesia. To date, no studies have focused on the fear-inducing effect that different pain intensities or verbal threat suggestions may have and how this fear, in turn, may strengthen the acquisition of nocebo effects. This study aims to investigate whether higher pain intensity or higher pain-related fear induced via threatening suggestions facilitate the acquisition and hinder subsequent extinction of nocebo hyperalgesia. This study will be conducted at Leiden University.
Study details
- Official title
- Pain-related Fear as a Facilitator of Nocebo Hyperalgesia: An Experimental Study
- Conditions
- Hyperalgesia
- Chronic Pain Syndrome
- Chronic Pain, Psychogenic
- Fear of Pain
- Interventions
- Behavioral: Threat manipulation (control, no threat)
- Behavioral: Threat manipulation
- Behavioral: Conditioning of moderate pain
- Behavioral: Conditioning of high pain
- Behavioral: Extinction
- Sponsor
- Leiden University Medical Center
- Collaborators
- Universiteit Leiden; KU Leuven; Maastricht University
- Start date
- 2019-10-14
- Primary completion
- 2020-02-14
- Sex
- All
- Age range
- from 17 Years to 35 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Aged 17 - 35 years * Good understanding of the English language * Normal or corrected to normal vision Exclusion Criteria: * Ever having experienced serious medical or psychiatric conditions (e.g., heart or lung disease, panic attacks, drug addiction, clinical depression), * Ever having experienced chronic pain complaints (pain for more than 6 months), * Experiencing acute physical pain (e.g., headache; above 3 on a 10-point NRS scale), or having used pain medication on the day of testing, * Pregnancy or breastfeeding, * Having recent injuries to the wrists or arms on the day of testing, * Previous participation in this or similar studies (e.g., using conditioning or thermal pain). * Having consumed psychotropic medication, recreational drugs, analgesic medication, or more than 3 units of alcohol, in the 24 hours prior to the study appointment. * After inclusion, participants who do not reach a sensation of high pain (at least 6 on the NRS) with the highest administered temperature or participants who appear unable to distinguish between moderate and high pain stimuli (reporting at least a mean difference of 1.5 NRS points between nocebo and control trials during induction) will also be excluded.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04197154