NCT04387851|CompletedDMC
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Sponsor study identifier
observational
130
1 country
1
Study Start
March 1, 2019
Actual (reported)Primary Completion
December 1, 2021
Actual (reported)Study Completion
December 1, 2021
Actual (reported)Placebo and nocebo effects are defined as the positive and negative effects occurring after the (supposed) administration of an inert treatment, which, through a given learning process, is believed to have positive or negative effects. The objective of this study is to summarize the available knowledge on experimental inductions of placebo and nocebo effects on somatosensory sensations, specifically pain and itch. The aim isto investigate the extent to which learning processes (such as conditioning and verbal suggestions) induce placebo and nocebo effects on pain and itch in healthy humans. The researchers intent to examine expectancy induction methods for placebo and nocebo effects on somatosensory sensations, describe methodological attributes of the research and propose practical and theoretical implications as well as future directions for research investigating placebo and nocebo effects on somatosensory sensations.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 1, 2021
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2019
Actual (reported)May 11, 2020
Actual (reported)May 14, 2020
Actual (reported)December 1, 2021
Actual (reported)December 1, 2021
Actual (reported)Placebo magnitude
The magnitude of induced placebo effects, by measures including, but not limited to, self-report measures of perceived sensation intensity or unpleasantness (e.g., as rated on a visual analogue scale or numerical rating scale).
Through study completion, an average of 1 month
Nocebo magnitude
The magnitude of induced nocebo effects, by measures including, but not limited to, self-report measures of perceived sensation intensity or unpleasantness (e.g., as rated on a visual analogue scale or numerical rating scale).
Through study completion, an average of 1 month
Placebo effects are defined as the positive effects occurring after the (supposed) administration of an inert treatment, which, through a given learning process, is believed to have positive effects.
Nocebo effects are defined as the negative effects occurring after the (supposed) administration of an inert treatment, which, through a given learning process, is believed to have negative effects.
The placebo interventions of interest are experimental learning methods (e.g. verbal suggestion, conditioning), used to induce placebo effects on somatosensory sensations.
Placebo and nocebo effects should be measured relative to a control group (between-subjects design). In the case of within-subjects designs, these will be included to the extent possible (in a separate analysis or descriptively depending on the number of results).
Healthy, adult human volunteers. Patient samples will not be included to improve homogeneity of the results.
Leiden University
Leiden, South Holland, 2333 AK, Netherlands
Thomaidou MA, Blythe JS, Peerdeman KJ, van Laarhoven AIM, Van Schothorst MME, Veldhuijzen DS, Evers AWM. Learned Nocebo Effects on Cutaneous Sensations of Pain and Itch: A Systematic Review and Meta-analysis of Experimental Behavioral Studies on Healthy Humans. Psychosom Med. 2023 May 1;85(4):308-321. doi: 10.1097/PSY.0000000000001194. Epub 2023 Mar 23.
Blythe JS, Thomaidou MA, Peerdeman KJ, van Laarhoven AIM, van Schothorst MME, Veldhuijzen DS, Evers AWM. Placebo effects on cutaneous pain and itch: a systematic review and meta-analysis of experimental results and methodology. Pain. 2023 Jun 1;164(6):1181-1199. doi: 10.1097/j.pain.0000000000002820. Epub 2022 Nov 16.
Andrea WM Evers, Prof. Dr.
Leiden University Medical Center
130 participants (actual enrollment reported by the registry).
First Submitted
May 11, 2020
First Posted
May 14, 2020
Study Start
March 1, 2019
Actual (reported)Methadone and Ketamine for Spinal Surgery
Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy
The nocebo interventions of interest are experimental learning methods (e.g. verbal suggestion, conditioning), used to induce nocebo effects on somatosensory sensations.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 1, 2021
Actual (reported)Study Completion
December 1, 2021
Actual (reported)Last Updated
January 11, 2022
Record last verified: 2022-01
No personal data are collected, stored, or shared. Data collection is monitored by the department's Data Monitor.
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Source: ClinicalTrials.gov.
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