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      A virtual experimenter to increase standardization for the investigation of placebo effects

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          Abstract

          Background

          Placebo effects are mediated by expectancy, which is highly influenced by psychosocial factors of a treatment context. These factors are difficult to standardize. Furthermore, dedicated placebo research often necessitates single-blind deceptive designs where biases are easily introduced. We propose a study protocol employing a virtual experimenter – a computer program designed to deliver treatment and instructions – for the purpose of standardization and reduction of biases when investigating placebo effects.

          Methods

          To evaluate the virtual experimenter’s efficacy in inducing placebo effects via expectancy manipulation, we suggest a partially blinded, deceptive design with a baseline/retest pain protocol (hand immersions in hot water bath). Between immersions, participants will receive an (actually inert) medication. Instructions pertaining to the medication will be delivered by one of three metaphors: The virtual experimenter, a human experimenter, and an audio/text presentation (predictor “Metaphor”). The second predictor includes falsely informing participants that the medication is an effective pain killer, or correctly informing them that it is, in fact, inert (predictor “Instruction”). Analysis will be performed with hierarchical linear modelling, with a sample size of N = 50. Results from two pilot studies are presented that indicate the viability of the pain protocol ( N = 33), and of the virtual experimenter software and placebo manipulation ( N = 48).

          Discussion

          It will be challenging to establish full comparability between all metaphors used for instruction delivery, and to account for participant differences in acceptance of their virtual interaction partner. Once established, the presence of placebo effects would suggest that the virtual experimenter exhibits sufficient cues to be perceived as a social agent. He could consequently provide a convenient platform to investigate effects of experimenter behavior, or other experimenter characteristics, e.g., sex, age, race/ethnicity or professional status. More general applications are possible, for example in psychological research such as bias research, or virtual reality research. Potential applications also exist for standardizing clinical research by documenting and communicating instructions used in clinical trials.

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          Most cited references57

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          Machines and Mindlessness: Social Responses to Computers

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            Self-disclosure in computer-mediated communication: The role of self-awareness and visual anonymity

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              A systematic literature review of 10 years of research on sex/gender and experimental pain perception - part 1: are there really differences between women and men?

              The purpose of this systematic review was to summarize and critically appraise the results of 10 years of human laboratory research on pain and sex/gender. An electronic search strategy was designed by a medical librarian and conducted in multiple databases. A total of 172 articles published between 1998 and 2008 were retrieved, analyzed, and synthesized. The first set of results (122 articles), which is presented in this paper, examined sex difference in the perception of laboratory-induced thermal, pressure, ischemic, muscle, electrical, chemical, and visceral pain in healthy subjects. This review suggests that females (F) and males (M) have comparable thresholds for cold and ischemic pain, while pressure pain thresholds are lower in F than M. There is strong evidence that F tolerate less thermal (heat, cold) and pressure pain than M but it is not the case for tolerance to ischemic pain, which is comparable in both sexes. The majority of the studies that measured pain intensity and unpleasantness showed no sex difference in many pain modalities. In summary, 10 years of laboratory research have not been successful in producing a clear and consistent pattern of sex differences in human pain sensitivity, even with the use of deep, tonic, long-lasting stimuli, which are known to better mimic clinical pain. Whether laboratory studies in healthy subjects are the best paradigm to investigate sex differences in pain perception is open to question and should be discussed with a view to enhancing the clinical relevance of these experiments and developing new research avenues. Copyright © 2011 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
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                Author and article information

                Contributors
                bhoring@clemson.edu
                Journal
                BMC Med Res Methodol
                BMC Med Res Methodol
                BMC Medical Research Methodology
                BioMed Central (London )
                1471-2288
                18 July 2016
                18 July 2016
                2016
                : 16
                : 84
                Affiliations
                [ ]Department of Psychology, Clemson University, Clemson, SC USA
                [ ]Human-Centered Computing Division, School of Computing, Clemson University, Clemson, SC USA
                [ ]Department of Psychosomatic Medicine and Psychotherapy, University Hospital Tübingen, Tübingen, Germany
                Article
                185
                10.1186/s12874-016-0185-4
                4950761
                27430476
                925cedcf-ca19-4549-b89b-b762b8e2a9a6
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 14 October 2015
                : 7 July 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100006498, Clemson University;
                Funded by: FundRef http://dx.doi.org/10.13039/100005156, Alexander von Humboldt-Stiftung;
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2016

                Medicine
                virtual reality,placebo mechanisms,placebo analgesia,bias,blinding,standardization
                Medicine
                virtual reality, placebo mechanisms, placebo analgesia, bias, blinding, standardization

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