Marinelli Veronica, Danzi Olivia Purnima, Mazzi Maria Angela, Secchettin Erica, Tuveri Massimiliano, Bonamini Deborah, Rimondini Michela, Salvia Roberto, Bassi Claudio, Del Piccolo Lidia
Department of Surgery, Dentistry, Pediatrics and Gynecology, University of Verona, Verona, Italy.
Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Verona, Italy.
Front Psychol. 2020 Mar 5;11:362. doi: 10.3389/fpsyg.2020.00362. eCollection 2020.
The aim of the present paper is to establish feasibility and required power of a one-session psychological intervention devoted to increasing patient's self-efficacy and awareness in dealing with anxiety symptoms before major pancreatic cancer surgery.
Parallel assignment RCT. All consenting patients listed for pancreatic major surgery during day-hospital visits (T0) between June 2017-June 2018 were assigned randomly in blocks of ten to a psychological intervention vs usual care group to be held the day before surgery (T1). The psychological intervention provided the patient the opportunity to increase self-efficacy in dealing with anxiety by talking with a psychologist about personal concerns and learning mindfulness based techniques to cope with anxiety.
400 patients were randomized into the experimental vs. usual care group. 49 and 65, respectively, completed baseline and post-intervention measures. The dropout rate between day-hospital (T0) and pre-surgery intervention (T1) was high (74.5%) due to several management and organization pitfalls. The main outcome, perceived self-efficacy in managing anxiety, showed a significant increase in the intervention group compared to the control group ( < 0.001), and was related to a reduction in state anxiety ( < 0.001). The intervention group perceived also lower emotional pain ( = 0.03). A power analysis was performed to define the appropriate sample size in a definitive RCT.
Beneath the complexity in retaining patients along their trajectory in pancreatic surgery department, when they had the opportunity to follow a brief psychological intervention, most of them adhered, showing a significant reduction in preoperative emotional distress and less emotional pain perception after surgery. Even if results need caution because of the high attrition rate, we can infer that our psychological intervention has the potential to be proposed in surgical setting, being short, easy to learn and applicable to a wide range of patients.
The trial was registered on ClinicalTrials.gov (identifier: NCT03408002). The full protocol is available from the last author.
本文旨在确定一项一次性心理干预措施的可行性及所需效能，该干预旨在提高胰腺癌大手术患者应对焦虑症状的自我效能和意识。
平行分组随机对照试验。2017年6月至2018年6月日间医院就诊（T0）期间所有同意接受胰腺大手术的患者，按十人为一组随机分组，分为心理干预组和常规护理组，干预在手术前一天（T1）进行。心理干预为患者提供了通过与心理学家谈论个人担忧并学习基于正念的技巧来应对焦虑，从而提高应对焦虑的自我效能的机会。
400名患者被随机分为试验组和常规护理组。分别有49名和65名患者完成了基线和干预后测量。由于一些管理和组织方面的问题，日间医院（T0）到术前干预（T1）之间的失访率很高（74.5%）。主要结局指标，即应对焦虑的自我效能感，干预组与对照组相比有显著提高（<0.001），且与状态焦虑的降低相关（<0.001）。干预组还感觉到较低的情绪痛苦（=0.03）。进行了效能分析以确定确定性随机对照试验中的合适样本量。
尽管在胰腺外科病房患者治疗过程中留住患者存在复杂性，但当他们有机会接受简短的心理干预时，大多数患者坚持下来，术前情绪困扰显著减轻，术后情绪痛苦感知减少。即使由于高失访率结果需谨慎对待，但我们可以推断我们的心理干预在手术环境中有被采用的潜力，因为它简短、易于学习且适用于广泛的患者群体。
该试验已在ClinicalTrials.gov上注册（标识符：NCT03408002）。完整方案可向最后一位作者索取。
