Placebo research has shown that optimizing positive treatment expectations, as can be achieved through the administration of placebos and education, has clinically relevant effects on preoperative anxiety, pain and treatment outcomes. As the administration of deceptive placebos raises ethical issues, clinical trials have increasingly focused on the use of open-label placebo (OLP).
This clinical trial seeks to reduce preoperative anxiety by optimizing positive treatment expectations using OLPs. In addition, this study will examine potential enhancement of these effects through aspects of observational learning, operationalized by a positive expectation-enhancing video, and explores patients' perspectives on the self-efficacy and appropriateness of OLPs prior to surgery.
To achieve these goals, patients are randomly assigned to one of three groups before undergoing gynecological laparoscopic surgery. One group will receive the OLP with a positive rationale provided by a study physician. A second group receives the same intervention, the administration of the OLP and the rationale by a physician, and also watches a video about OLP showing a satisfied patient. A third group receives the usual standard treatment (also called “treatment as usual”). Preoperative anxiety and postoperative experiences, in particular visceral and somatic postoperative pain, are measured. These plans have now been further developed in a study protocol by the team of authors led by Dr. Johannes Wessels and Dr. Jana Aulenkamp.
Read the original publication in the journal Frontiers in Psychiatry here.
