Nocebo effects in visceral pain: concept and design of the experimental randomized-controlled pain study ‘NoVis’

The role of psychological factors in the pathophysiology and treatment of chronic visceral pain in disorders of gut-brain interactions (DGBI) is increasingly appreciated. Placebo research has underscored that expectations arising from the psychosocial treatment context and from prior experiences sha...

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Main Authors: Jana Luisa Aulenkamp, Adriane Icenhour, Sigrid Elsenbruch
Format: Article
Language:English
Published: Frontiers Media S.A. 2023-10-01
Series:Frontiers in Psychiatry
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1270189/full
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author Jana Luisa Aulenkamp
Jana Luisa Aulenkamp
Adriane Icenhour
Sigrid Elsenbruch
Sigrid Elsenbruch
author_facet Jana Luisa Aulenkamp
Jana Luisa Aulenkamp
Adriane Icenhour
Sigrid Elsenbruch
Sigrid Elsenbruch
author_sort Jana Luisa Aulenkamp
collection DOAJ
description The role of psychological factors in the pathophysiology and treatment of chronic visceral pain in disorders of gut-brain interactions (DGBI) is increasingly appreciated. Placebo research has underscored that expectations arising from the psychosocial treatment context and from prior experiences shape treatment responses. However, effects of negative expectations, i.e., nocebo effects, as they are likely crucial elements of DGBI patients’ clinical reality, have thus far only rarely been investigated in the context of visceral pain, with untapped potential for improved prevention and treatment. The experimental randomized-controlled pain study “NoVis,” carried out within the Collaborative Research Center (CRC) 289 (“Treatment Expectation”), aims to close gaps regarding the generation and persistence of nocebo effects in healthy volunteers. It is designed to elucidate effects of negative expectations in a multiple-threat paradigm with intensity-matched rectal distensions and cutaneous thermal stimuli, allowing to test nocebo effects in the visceral and somatic pain modalities. Negative expectations are experimentally induced by elements of doctor-patient communication (i.e., instruction) and/or by surreptitious amplification of symptom intensity (i.e., experience/learning) within a treatment context. Accordingly, the repeated measures between-subject design contains the between-group factors “treatment instruction” (negative vs. control) and “treatment experience” (negative vs. control), with volunteers randomized into four experimental groups undergoing several pain stimulation phases (repeated factor). This allows to compare the efficacy of instruction vs. experience, and more importantly, their combined effects on the magnitude of negative expectations and their impact on pain responses, which we expect will be greatest for the visceral modality. After a Baseline, short-term effects are assessed during a test phase accomplished on study day 1 (Test-1 Phase). To explore the persistence of effects, a second test phase is accomplished 1 week later (Test-2 Phase). Effects of negative expectations within and across pain modalities are assessed at the subjective and objective levels, with a focus on psychophysiological and neuroendocrine measures related to stress, fear, and anxiety. Since nocebo effects can play a considerable role in the generation, maintenance, or worsening of chronic visceral pain, and may even constitute risk factors for treatment failure, knowledge from experimental nocebo research has potential to improve treatment outcomes in DGBI and other clinical conditions associated with chronic visceral pain.
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spelling doaj.art-c6a7cf04f27c4f599ef4127759522b862023-10-13T05:27:03ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402023-10-011410.3389/fpsyt.2023.12701891270189Nocebo effects in visceral pain: concept and design of the experimental randomized-controlled pain study ‘NoVis’Jana Luisa Aulenkamp0Jana Luisa Aulenkamp1Adriane Icenhour2Sigrid Elsenbruch3Sigrid Elsenbruch4Department of Anesthesiology and Intensive Care Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, GermanyDepartment of Neurology, Center for Translational Neuro- and Behavioral Sciences (C-TNBS), University Hospital Essen, University of Duisburg-Essen, Essen, GermanyDepartment of Medical Psychology and Medical Sociology, Ruhr University Bochum, Bochum, GermanyDepartment of Neurology, Center for Translational Neuro- and Behavioral Sciences (C-TNBS), University Hospital Essen, University of Duisburg-Essen, Essen, GermanyDepartment of Medical Psychology and Medical Sociology, Ruhr University Bochum, Bochum, GermanyThe role of psychological factors in the pathophysiology and treatment of chronic visceral pain in disorders of gut-brain interactions (DGBI) is increasingly appreciated. Placebo research has underscored that expectations arising from the psychosocial treatment context and from prior experiences shape treatment responses. However, effects of negative expectations, i.e., nocebo effects, as they are likely crucial elements of DGBI patients’ clinical reality, have thus far only rarely been investigated in the context of visceral pain, with untapped potential for improved prevention and treatment. The experimental randomized-controlled pain study “NoVis,” carried out within the Collaborative Research Center (CRC) 289 (“Treatment Expectation”), aims to close gaps regarding the generation and persistence of nocebo effects in healthy volunteers. It is designed to elucidate effects of negative expectations in a multiple-threat paradigm with intensity-matched rectal distensions and cutaneous thermal stimuli, allowing to test nocebo effects in the visceral and somatic pain modalities. Negative expectations are experimentally induced by elements of doctor-patient communication (i.e., instruction) and/or by surreptitious amplification of symptom intensity (i.e., experience/learning) within a treatment context. Accordingly, the repeated measures between-subject design contains the between-group factors “treatment instruction” (negative vs. control) and “treatment experience” (negative vs. control), with volunteers randomized into four experimental groups undergoing several pain stimulation phases (repeated factor). This allows to compare the efficacy of instruction vs. experience, and more importantly, their combined effects on the magnitude of negative expectations and their impact on pain responses, which we expect will be greatest for the visceral modality. After a Baseline, short-term effects are assessed during a test phase accomplished on study day 1 (Test-1 Phase). To explore the persistence of effects, a second test phase is accomplished 1 week later (Test-2 Phase). Effects of negative expectations within and across pain modalities are assessed at the subjective and objective levels, with a focus on psychophysiological and neuroendocrine measures related to stress, fear, and anxiety. Since nocebo effects can play a considerable role in the generation, maintenance, or worsening of chronic visceral pain, and may even constitute risk factors for treatment failure, knowledge from experimental nocebo research has potential to improve treatment outcomes in DGBI and other clinical conditions associated with chronic visceral pain.https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1270189/fullgut-brain axisnocebo effectvisceral painsomatic painvisceral hyperalgesiatreatment expectations
spellingShingle Jana Luisa Aulenkamp
Jana Luisa Aulenkamp
Adriane Icenhour
Sigrid Elsenbruch
Sigrid Elsenbruch
Nocebo effects in visceral pain: concept and design of the experimental randomized-controlled pain study ‘NoVis’
Frontiers in Psychiatry
gut-brain axis
nocebo effect
visceral pain
somatic pain
visceral hyperalgesia
treatment expectations
title Nocebo effects in visceral pain: concept and design of the experimental randomized-controlled pain study ‘NoVis’
title_full Nocebo effects in visceral pain: concept and design of the experimental randomized-controlled pain study ‘NoVis’
title_fullStr Nocebo effects in visceral pain: concept and design of the experimental randomized-controlled pain study ‘NoVis’
title_full_unstemmed Nocebo effects in visceral pain: concept and design of the experimental randomized-controlled pain study ‘NoVis’
title_short Nocebo effects in visceral pain: concept and design of the experimental randomized-controlled pain study ‘NoVis’
title_sort nocebo effects in visceral pain concept and design of the experimental randomized controlled pain study novis
topic gut-brain axis
nocebo effect
visceral pain
somatic pain
visceral hyperalgesia
treatment expectations
url https://www.frontiersin.org/articles/10.3389/fpsyt.2023.1270189/full
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