Ignite Creation Date:
2024-05-06 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05284383
Status:
COMPLETED
Last Update Posted:
2022-08-25
First Post:
2022-02-17
Brief Title:
Reducing Nocebo Effects on Pressure Pain
Sponsor:
Leiden University
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Reducing Nocebo Effects on Pressure Pain open-and Closed-label Counterconditioning and Extinction Compared
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nocebo effects are known to adversely affect the experience of various physical symptoms such as pain and itch Nocebo effects can be induced by associative learning mechanisms of classical conditioning Furthermore recent studies have shown that counterconditioning can successfully reduce nocebo effects and to a larger extent than mere extinction which suggests counterconditioning can be an innovative method for desensitization of symptoms When using such procedures in clinical practice deception of patients should be avoided as much as possible The use of open-label procedures could provide a promising alternative While previous studies have already shown that open-label placebos are effective the effects of open-label counterconditioning and closed-label counterconditioning are not extensively investigated in comparison to other strategies such as extinction and not yet compared amongst each other Before implementing such a procedure in clinical practice it would be relevant to get an insight in the efficacy of both open- and closed-label counterconditioning in healthy participants as compared to extinction and to investigate whether open-label counterconditioning can be equally effective as closed-label counterconditioning Furthermore it would be relevant to study the induction and reduction of nocebo effects using a pain modality that mimics the type of pain that people suffering from several chronic pain conditions experience such as pressure pain The main aim of the current study is to investigate whether open- and closed-label counterconditioning are more effective in reducing nocebo effects than extinction To this aim it will be investigated whether open- and closed-label counterconditioning lead to stronger reductions in nocebo effects on pressure pain than closed-label extinction and whether all three successfully reduce nocebo effects Finally it will be tested whether open- and closed label counterconditioning are comparable in effectivity
Detailed Description:
The primary objective of the study is to investigate whether open- and closed-label counterconditioning are more effective in reducing nocebo effects than extinction
The experimental open- and closed-label counterconditioning and control extinction groups will be compared on the change in the nocebo effect from before to after counterconditioning The nocebo effect is defined as the mean difference in self-reported pain ratings on a numeric rating scale from 0 no pain to 10 worst pain imaginableduring all experimental trials and control trials in the test phase of nocebo conditioning and the test phase of counterconditioningextinction The reduction of the nocebo effect will be determined by calculating the mean difference between the nocebo effect after conditioning and after counterconditioningextinction It is expected that participants in both counterconditioning groups will show a larger reduction of the nocebo effect than participants in the extinction group A one-way ANOVA will be conducted to examine the main effect of group on the amount of change in nocebo effects Then post-hoc analyses will be conducted after the primary analysis to test for differences between the three forms of nocebo reduction
Secondary it will be tested whether all three procedures open- and closed-label counterconditioning and extinction lead to a significant reduction of the nocebo effect by comparing the amount of reduction to test value 0 It is hypothesized that all groups show a significant reduction
Finally it will be investigated whether open- and closed-label counterconditioning procedures are comparable in terms of their ability to reduce nocebo effects on pressure pain Both groups are expected to be comparable in efficacy of reducing the nocebo effect
The experimental open- and closed-label counterconditioning and control extinction groups will be compared on the change in the nocebo effect from before to after counterconditioning The nocebo effect is defined as the mean difference in self-reported pain ratings on a numeric rating scale from 0 no pain to 10 worst pain imaginableduring all experimental trials and control trials in the test phase of nocebo conditioning and the test phase of counterconditioningextinction The reduction of the nocebo effect will be determined by calculating the mean difference between the nocebo effect after conditioning and after counterconditioningextinction It is expected that participants in both counterconditioning groups will show a larger reduction of the nocebo effect than participants in the extinction group A one-way ANOVA will be conducted to examine the main effect of group on the amount of change in nocebo effects Then post-hoc analyses will be conducted after the primary analysis to test for differences between the three forms of nocebo reduction
Secondary it will be tested whether all three procedures open- and closed-label counterconditioning and extinction lead to a significant reduction of the nocebo effect by comparing the amount of reduction to test value 0 It is hypothesized that all groups show a significant reduction
Finally it will be investigated whether open- and closed-label counterconditioning procedures are comparable in terms of their ability to reduce nocebo effects on pressure pain Both groups are expected to be comparable in efficacy of reducing the nocebo effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None