468
Views
1
CrossRef citations to date
0
Altmetric
Research Article

Nocebo effects on informed consent within medical and psychological settings: A scoping review

ORCID Icon, ORCID Icon & ORCID Icon

REFERENCES

  • Amanzio, M., Corazzini, L. L., Vase, L., & Benedetti, F. (2009). A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain, 146(3), 261–269. https://doi.org/10.1016/j.pain.2009.07.010
  • Aromataris, E., & Munn, Z. (2020). JBI Manual for Evidence Synthesis. JBI. https://synthesismanual.jbi.global
  • Assefi, S. L., & Garry, M. (2003). Absolut® memory distortions: Alcohol placebos influence the misinformation effect. Psychological Science, 14(1), 77–80. https://doi.org/10.1111/1467-9280.01422
  • Barnes, K., Faasse, K., Geers, A. L., Helfer, S. G., Sharpe, L., Colloca, L., & Colagiuri, B. (2019). Can positive framing reduce nocebo side effects? Current evidence and recommendation for future research. Frontiers in Pharmacology, 10, 167. https://doi.org/10.3389/fphar.2019.00167
  • Barsky, A. J., Saintfort, R., Rogers, M. P., & Borus, J. F. (2002). Nonspecific medication side effects and the nocebo phenomenon. Jama, 287(5), 622–627. https://doi.org/10.1001/jama.287.5.622.
  • Bartels, D. J., van Laarhoven, A. I., van de Kerkhof, P. C., & Evers, A. W. (2016). Placebo and nocebo effects on itch: Effects, mechanisms, and predictors. European Journal of Pain, 20(1), 8–13. https://doi.org/10.1002/ejp.750
  • Bridgland, V. M., Green, D. M., Oulton, J. M., & Takarangi, M. K. (2019). Expecting the worst: Investigating the effects of trigger warnings on reactions to ambiguously themed photos. Journal of Experimental Psychology. Applied, 25(4), 602. https://doi.org/10.1037/xap0000215.
  • Bridgland, V. M., & Takarangi, M. K. (2021). Danger! Negative memories ahead: The effect of warnings on reactions to and recall of negative memories. Memory, 29(3), 319–329. https://doi.org/10.1080/09658211.2021.1892147
  • Bridgland, V. M., Barnard, J. F., & Takarangi, M. K. (2022). Unprepared: Thinking of a trigger warning does not prompt preparation for trauma-related content. Journal of Behavior Therapy and Experimental Psychiatry, 75, 101708. https://doi.org/10.1016/j.jbtep.2021.101708
  • Bussell, N. (2017). The effects of informed consent risk language on trauma research results (Doctoral dissertation, Alliant International University)
  • Cohen, S. (2014). The nocebo effect of informed consent. Bioethics, 28(3), 147–154. https://doi.org/10.1111/j.1467-8519.2012.01983.x
  • Colloca, L. (2015). Informed consent: Hints from placebo and nocebo research. The American Journal of Bioethics, 15(10), 17–19. https://doi.org/10.1080/15265161.2015.1074314
  • Colloca, L. (2017). Tell me the truth and I will not be harmed: Informed consents and nocebo effects. The American Journal of Bioethics, 17(6), 46–48. https://doi.org/10.1080/15265161.2017.1314057
  • Crichton, F., & Petrie, K. J. (2015). Health complaints and wind turbines: The efficacy of explaining the nocebo response to reduce symptom reporting. Environmental Research, 140, 449–455. https://doi.org/10.1016/j.envres.2015.04.016
  • de Wied, M., Hoffman, K., & Roskos-Ewoldsen, D. R. (1997). Forewarning of graphic portrayal of violence and the experience of suspenseful drama. Cognition & Emotion, 11(4), 481–494. https://doi.org/10.1080/026999397379890
  • Douglas, B. D., McGorray, E. L., & Ewell, P. J. (2021). Some researchers wear yellow pants, but even fewer participants read consent forms: Exploring and improving consent form reading in human subjects research. Psychological Methods, 26(1), 61. https://doi.org/10.31234/osf.io/hcvk6
  • Faasse, K., Huynh, A., Pearson, S., Geers, A. L., Helfer, S. G., & Colagiuri, B. (2019). The influence of side effect information framing on nocebo effects. Annals of Behavioral Medicine, 53(7), 621–629. https://doi.org/10.1093/abm/kay071
  • Fleming, T. E. (1997). Negative sequelae to hypnosis: A function of expectation?. California State University. [Doctoral Thesis]
  • Fortunato, J. T., Wasserman, J. A., & Menkes, D. L. (2017). When respecting autonomy is harmful: A clinically useful approach to the nocebo effect. The American Journal of Bioethics, 17(6), 36–42. https://doi.org/10.1080/15265161.2017.1314042
  • Gelfand, S. (2020). The nocebo effect and informed consent—Taking autonomy seriously. Cambridge Quarterly of Healthcare Ethics, 29(2), 223–235. https://doi.org/10.1017/S0963180119001026
  • Hahn, R. A. (1997). The nocebo phenomenon: Concept, evidence, and implications for public health. Preventive Medicine, 26(5), 607–611. https://doi.org/10.1006/pmed.1996.0124
  • Hardwicke, T. E., Thibault, R. T., Kosie, J. E., Wallach, J. D., Kidwell, M. C., & Ioannidis, J. P. (2022). Estimating the prevalence of transparency and reproducibility-related research practices in psychology (2014–2017). Perspectives on Psychological Science, 17(1), 239–251. https://doi.org/10.1177/1745691620979806
  • Heisig, S. R., Shedden-Mora, M. C., Hidalgo, P., & Nestoriuc, Y. (2015). Framing and personalizing informed consent to prevent negative expectations: An experimental pilot study. Health Psychology, 34(10), 1033. https://doi.org/10.1093/abm/kaaa115
  • Holzhüter, F., & Hamann, J. (2020). Nocebo effects by providing informed consent in shared decision making? Not necessarily: A randomized pilot-trial using an open-label placebo approach. BMC Medical Ethics, 21(1), 1–4. https://doi.org/10.1186/s12910-020-00541-y
  • Kahneman, D., & Tversky, A. (1979). On the interpretation of intuitive probability: A reply to Jonathan Cohen. Cognition, 7(4), 409–411. https://doi.org/10.1016/0010-0277(79)90024-6
  • Kirsch, I. (1985). Response expectancy as a determinant of experience and behavior. American Psychologist, 40(11), 1189. https://doi.org/10.1037/0003-066x.40.11.1189
  • Kirsch, I. (1997). Response expectancy theory and application: A decennial review. Applied and Preventive Psychology, 6(2), 69–79. https://doi.org/10.1016/S0962-1849(05)80012-5
  • Lakens, D. (2017). Will knowledge about more efficient study designs increase the willingness to pre-register? https://osf.io/pwtrh/
  • Lakens, D. (2021). Sample size justification [submitted for peer review].
  • Levin, I. P., Schneider, S. L., & Gaeth, G. J. (1998). All frames are not created equal: A typology and critical analysis of framing effects. Organizational Behavior and Human Decision Processes, 76(2), 149–188. https://doi.org/10.1006/obhd.1998.2804
  • Lin, H., Werner, K. M., & Inzlicht, M. (2021). Promises and perils of experimentation: The mutual-internal-validity problem. Perspectives on Psychological Science 16(4), 854–863. https://doi.org/10.31234/osf.io/hwubj
  • Loftus, E. F., & Fries, J. F. (1979). Informed consent may be hazardous to health. Science, 204(4388), 11. https://doi.org/10.1126/science.373117
  • Loftus, E. F., & Fries, J. F. (2008). The potential perils of informed consent. McGill Journal of Medicine: MJM, 11(2), 217. https://doi.org/10.26443/mjm.v11i2.486
  • Mann, T. (1994). Informed consent for psychological research: Do subjects comprehend consent forms and understand their legal rights? Psychological Science, 5(3), 140–143. https://doi.org/10.1111/j.1467-9280.1994.tb00650.x
  • McNutt, L. A., Waltermaurer, E., Bednarczyk, R. A., Carlson, B. E., Kotval, J., McCauley, J., and Ford, D. E. (2008). Are we misjudging how well informed consent forms are read? Journal of Empirical Research on Human Research Ethics, 3(1), 89–97. https://doi.org/10.1525/jer.2008.3.1.89.
  • Meeuwis, S. H., van Middendorp, H., van Laarhoven, A. I., van Leijenhorst, C., Pacheco-Lopez, G., Lavrijsen, A. P., … Evers, A. W. (2020). Placebo and nocebo effects for itch and itch-related immune outcomes: A systematic review of animal and human studies. Neuroscience and Biobehavioral Reviews, 113, 325–337. https://doi.org/10.1016/j.neubiorev.2020.03.025
  • Meijer, S., Karacaoglu, M., van Middendorp, H., Veldhuijzen, D. S., Jensen, K., Peerdeman, K., & Evers, A. (2021). Efficacy of open-label counterconditioning for reducing nocebo effects on pressure pain. PsyArXiv. https://doi.org/10.31234/osf.io/uhd3s
  • Michael, R. B., Garry, M., & Kirsch, I. (2012). Suggestion, cognition, and behavior. Current Directions in Psychological Science, 21(3), 151–156. https://doi.org/10.1177/0963721412446369
  • Mitsikostas, D. D., Mantonakis, L., & Chalarakis, N. (2014). Nocebo in clinical trials for depression: A meta-analysis. Psychiatry Research, 215(1), 82–86. https://doi.org/10.1016/j.psychres.2013.10.019
  • Mondaini, N., Gontero, P., Giubilei, G., Lombardi, G., Cai, T., Gavazzi, A., & Bartoletti, R. (2007). Finasteride 5 mg and sexual side effects: How many of these are related to a nocebo phenomenon? The Journal of Sexual Medicine, 4(6), 1708–1712. https://doi.org/10.1111/j.1743-6109.2007.00563.x
  • Montgomery, G. H., & Kirsch, I. (1997). Classical conditioning and the placebo effect. Pain, 72(1–2), 107–113. https://doi.org/10.1016/s0304-3959(97)00016-x
  • Myers, M. G., Cairns, J. A., & Singer, J. (1987). The consent form as a possible cause of side effects. Clinical Pharmacology and Therapeutics, 42(3), 250–253. https://doi.org/10.1038/clpt.1987.142
  • National Health and Medical Research Council. (2018). National statement on ethical conduct in human research. Canberra, Australia. https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018 .
  • Neukirch, N., & Colagiuri, B. (2015). The placebo effect, sleep difficulty, and side effects: A balanced placebo model. Journal of Behavioral Medicine, 38(2), 273–283. https://doi.org/10.1007/s10865-014-9590-5
  • Norris, E., He, Y., Loh, R., West, R., & Michie, S. (2021). Assessing markers of reproducibility and transparency in smoking behaviour change intervention evaluations. Journal of Smoking Cessation 2021, 6694386 https://doi.org/10.1155/2021/6694386
  • Perrault, E. K., & Keating, D. M. (2018). Seeking ways to inform the uninformed: Improving the informed consent process in online social science research. Journal of Empirical Research on Human Research Ethics, 13(1), 50–60. https://doi.org/10.1177/1556264617738846
  • Perugini, M., Gallucci, M., & Costantini, G. (2018). A practical primer to power analysis for simple experimental designs. International Review of Social Psychology, 31(1), 1–23. .https://doi.org/10.5334/irsp.181
  • Peters, M. D., Marnie, C., Tricco, A. C., Pollock, D., Munn, Z., Alexander, L., … Khalil, H. (2021). Updated methodological guidance for the conduct of scoping reviews. JBI Evidence Implementation, 19(1), 3–10. https://doi.org/10.1097/XEB.0000000000000277
  • Petersen, G. L., Finnerup, N. B., Colloca, L., Amanzio, M., Price, D. D., Jensen, T. S., & Vase, L. (2014). The magnitude of nocebo effects in pain: A meta-analysis. Pain®, 155(8), 1426–1434. https://doi.org/10.1016/j.pain.2014.04.016
  • Planès, S., Villier, C., & Mallaret, M. (2016). The nocebo effect of drugs. Pharmacology Research & Perspectives, 4(2), e00208. https://doi.org/10.1002/prp2.208
  • Pollo, A., Torre, E., Lopiano, L., Rizzone, M., Lanotte, M., Cavanna, A., … Benedetti, F. (2002). Expectation modulates the response to subthalamic nucleus stimulation in Parkinsonian patients. Neuroreport, 13(11), 1383–1386. https://doi.org/10.1097/00001756-200208070-00006
  • Reuter, U., Sanchez Del Rio, M., Carpay, J. A., Boes, C. J., & Silberstein, S. D., & GSK Headache Masters Program. (2003). Placebo adverse events in headache trials: Headache as an adverse event of placebo. Cephalalgia, 23(7), 496–503. https://doi.org/10.1046/j.1468-2982.2003.00530.x
  • Rief, W., Hofmann, S. G., & Nestoriuc, Y. (2008). The power of expectation–understanding the placebo and nocebo phenomenon. Social and Personality Psychology Compass, 2(4), 1624–1637. https://doi.org/10.1111/j.1751-9004.2008.00121.x
  • Rief, W., Barsky, A. J., Glombiewski, J. A., Nestoriuc, Y., Glaesmer, H., & Braehler, E. (2011). Assessing general side effects in clinical trials: Reference data from the general population. Pharmacoepidemiology and Drug Safety, 20(4), 405–415. https://doi.org/10.1002/pds.2067
  • Senn, C. Y., & Desmarais, S. (2006). A new wrinkle on an old concern: Are the new ethics review requirements for explicit warnings in consent forms affecting the results of sexuality research? Canadian Journal of Human Sexuality, 15(3–4).
  • Takarangi, M. K., & Strange, D. (2010). Emotional impact feedback changes how we remember negative autobiographical experiences. Experimental Psychology, 57(5). https://doi.org/10.1027/1618-3169/a000042
  • Tricco, A. C., Lillie, E., Zarin, W., O’Brien, K. K., Colquhoun, H., Levac, D., Moher, D., Peters, M. D. J., Horsley, T., Weeks, L., Hempel, S., Akl, E. A., Chang, C., McGowan, J., Stewart, L., Hartling, L., Aldcroft, A., Wilson, M. G., Garritty, C., … Straus, S. E. (2018). PRISMA extension for scoping reviews (PRISMA-ScR): Checklist and explanation. Annals of Internal Medicine, 169(7), 467–473. https://doi.org/10.7326/M18-0850
  • Tufanaru, C., Munn, Z., Aromataris, E., Campbell, J., & Hopp, L. (2017). Joanna Briggs Institute Reviewer’s Manual, 3. Adelaide: Joanna Briggs Institute.
  • Varelmann, D., Pancaro, C., Cappiello, E. C., & Camann, W. R. (2010). Nocebo-induced hyperalgesia during local anesthetic injection. Anesthesia and Analgesia, 110(3), 868–870. https://doi.org/10.1213/ANE.0b013e3181cc5727
  • Webster, R. K., Weinman, J., & Rubin, G. J. (2016). A systematic review of factors that contribute to nocebo effects. Health Psychology, 35(12), 1334. https://doi.org/10.1037/hea0000416
  • Wells, R. E., & Kaptchuk, T. J. (2012). To tell the truth, the whole truth, may do patients harm: The problem of the nocebo effect for informed consent. The American Journal of Bioethics, 12(3), 22–29. https://doi.org/10.1080/15265161.2011.652798
  • Wilhelm, M., Rief, W., & Doering, B. K. (2018). Decreasing the burden of side effects through positive message framing: An experimental proof-of-concept study. International Journal of Behavioral Medicine, 25(4), 381–389. https://doi.org/10.1007/s12529-018-9726-z
  • Zech, N., Seemann, M., Graf, B. M., & Hansen, E. (2015). Nocebo effects with the informed consent. Anasthesiologie, Intensivmedizin, Notfallmedizin, Schmerztherapie: AINS, 50(1), 64–69. https://doi.org/10.1055/s-0040-100081

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.