Clinical Applications of Placebo Research: Optimizing Expectation Effects in Cardiac Surgery Patients

安慰剂研究的临床应用：优化心脏手术患者的预期效果

• 批准号: 188233843
• 负责人: Professor Dr. Winfried Rief, Ph.D.
• 金额: --
• 依托单位: Klinik für Herz- und thorakale Gefäßchirurgie
• 依托单位国家: 德国
• 项目类别: Research Units
• 财政年份: 2010
• 资助国家: 德国
• 起止时间: 2009-12-31 至 2014-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/188233843?language=en
• 关键词: Clinical; Applications; Placebo; Research; Optimizing

Coronary artery bypass graft surgery (CABG) is an extremely invasive medical intervention. It is postulated that even under these conditions, treatment outcome is substantially determined by non-specific effects, e.g. patient‘s expectation. Targeting patients‘ expectations at an early stage might have potential to optimize outcomes after cardiac surgery. The purpose of this research project is to optimize patients‘ outcome expectations before undergoing cardiac surgery through a brief psycho-educational program. Using a randomized controlled design, 180 patients who are scheduled to undergo elective CABG are randomly assigned either to standard medical information alone, or to an additional expectation manipulation intervention (EMI) during the two weeks before surgery, or to an attention-control group (―supportive therapy‖). The main goal is to enhance positive expectations (surgery ‗non-specific effects‘) about favorable outcome through EMI, about coping abilities to deal with adverse events, and to reduce negative expectations and misconceptions. Assessment takes place before and after EMI, 10 days after surgery and 6 months later; same assessment points are used for the 2 control conditions. Primary outcome is disability, which has been shown to be strongly determined by patient‘s expectation in previous studies. Moreover, psychological and biological predictors and mediators of treatment success are analyzed. A positive result for this expectation intervention would have major implications for clinical practice. In order to optimize treatment outcome, it is not only necessary to improve the treatment-specific procedures (e.g., cardiac surgery) but also to address non-specific factors such as patients‘ expectations.

冠状动脉搭桥手术（CABG）是一种极具侵入性的医疗干预。假设即使在这些条件下，治疗结果基本上是由非特异性效应决定的，例如患者的期望。在早期阶段针对患者的期望可能有潜力优化心脏手术后的结果。本研究项目的目的是通过一个简短的心理教育项目来优化患者在接受心脏手术前的预期结果。采用随机对照设计，180名计划接受选择性冠脉搭桥的患者被随机分配到标准医疗信息组，或在手术前两周内额外的期望操纵干预组（EMI），或注意力控制组（支持治疗组）。主要目标是提高积极的期望（手术的非特异性效果），通过EMI的有利结果，关于应对能力，以处理不良事件，并减少消极的期望和误解。评估在EMI前后、术后10天和术后6个月进行；两种控制条件采用相同的评价点。主要结局是残疾，在以往的研究中，残疾在很大程度上取决于患者的期望。此外，心理和生物学的预测和中介治疗成功进行了分析。这种预期干预的积极结果将对临床实践产生重大影响。为了优化治疗效果，不仅需要改进治疗特异性程序（如心脏手术），还需要解决非特异性因素，如患者的期望。