电针对胃癌或结直肠癌手术患者围手术期焦虑及应激反应的影响：一项随机对照试验的研究方案
Effects of electroacupuncture on perioperative anxiety and stress response in patients undergoing surgery for gastric or colorectal cancer: Study protocol for a randomized controlled trial.
作者信息
Hou Yuchao, Lu Jiajing, Xie Jing, Zhu Runjia, Wu Mengdie, Wang Ke, Zhou Jia, Li Jing
机构信息
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
出版信息
Front Psychiatry. 2023 Feb 23;14:1095650. doi: 10.3389/fpsyt.2023.1095650. eCollection 2023.
BACKGROUND
Perioperative anxiety is one of the main psychological stresses experienced by patients who undergo cancer surgery. The surgery itself inevitably causes a stress response characterized by activation of the sympathetic nervous system and the hypothalamic-pituitary-adrenal axis. Both the perioperative anxiety and surgical stress response lead to increased levels of catecholamines and prostaglandins, which may be related to perioperative suppression of antimetastatic immunity and tumor-promoting alterations in the microenvironment. Hence, we designed this clinical trial to investigate the effect of electroacupuncture in reducing perioperative anxiety and surgical stress response.
METHODS
This is a randomized, single-center, parallel, and controlled clinical trial. Seventy-eight participants between the ages of 35 and 85 with gastric or colorectal cancer who plan to undergo tumorectomy will be randomly divided into an electroacupuncture group and a control group. The primary outcome will be the six-item short form of the State-Trait Anxiety Inventory score. The secondary outcomes will be the Amsterdam Preoperative Anxiety and Information Scale score; levels of plasma cortisol, adrenocorticotropic hormone, interleukin-6, and tumor necrosis factor-α; first exhaust time after surgery; postoperative quality of the recovery-15 score, numeric rating scale for pain score; and dosage of postoperative analgesics.
DISCUSSION
Cumulative studies revealed the efficacy of various types of acupuncture therapy with regard to reducing the anxiety and stress response caused by surgery. We expect that the results of this trial will provide high-quality clinical evidence for the choice of perioperative acupuncture for patients undergoing cancer surgery.
CLINICAL TRIAL REGISTRATION
https://www.chictr.org.cn, identifier ChiCTR200003 7127.
背景
围手术期焦虑是癌症手术患者经历的主要心理应激之一。手术本身不可避免地会引发以交感神经系统和下丘脑 - 垂体 - 肾上腺轴激活为特征的应激反应。围手术期焦虑和手术应激反应都会导致儿茶酚胺和前列腺素水平升高，这可能与围手术期抗转移免疫抑制以及微环境中促肿瘤改变有关。因此，我们设计了这项临床试验，以研究电针在减轻围手术期焦虑和手术应激反应方面的效果。
方法
这是一项随机、单中心、平行对照临床试验。78名年龄在35至85岁之间、计划接受肿瘤切除术的胃癌或结直肠癌患者将被随机分为电针组和对照组。主要结局指标将是状态 - 特质焦虑问卷简式量表的6项得分。次要结局指标将包括阿姆斯特丹术前焦虑与信息量表得分；血浆皮质醇、促肾上腺皮质激素、白细胞介素 - 6和肿瘤坏死因子 - α水平；术后首次排气时间；术后恢复质量 - 15评分、疼痛数字评分量表得分；以及术后镇痛药用量。
讨论
累积研究揭示了各种类型针灸疗法在减轻手术引起的焦虑和应激反应方面的疗效。我们期望该试验结果能为癌症手术患者围手术期针灸的选择提供高质量的临床证据。
临床试验注册
Zotero 插件