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术前护理访视可降低腹腔镜胆囊切除术患者的术前焦虑和术后并发症:一项随机临床试验方案。

Preoperative nursing visit reduces preoperative anxiety and postoperative complications in patients with laparoscopic cholecystectomy: A randomized clinical trial protocol.

作者信息

Xu Ying, Wang Hui, Yang Meijuan

机构信息

Department of Vascular surgical hernia and abdominal surgery, Taizhou Hospital of Zhejiang Province, Zhejiang, China.

出版信息

Medicine (Baltimore). 2020 Sep 18;99(38):e22314. doi: 10.1097/MD.0000000000022314.

Abstract

BACKGROUND

Anxiety is a kind of emotional disorder caused by acute conditions or trigger. It is manifested in the components of the autonomic nervous system, for instance, stress, anxiety, nervosity, and discomfort. Most patients with anxiety are more active, nervous, and alert to various stimuli. Inappropriate management of early postoperative anxiety will not only prolong recovery but also increase the risk of other complications. We conduct a randomized clinical trial to investigate the influences of nursing visits against the preoperative anxiety and postoperative complications in patients undergoing laparoscopic cholecystectomy (LC).

METHODS

This is a single center, placebo-controlled randomized trial, which will be performed from August 2020 to December 2020. The trial is performed in accordance with the SPIRIT Checklist for randomized studies. It is authorized by the Ethics Committee of Taizhou Hospital of Zhejiang Province (D20211-34). Two hundred patients undergoing LC will be included in this study. Patients are randomly divided into 2 groups: experiential group (n = 100) or control group (n = 100). The experimental group is given preoperative nursing visit to each patient 1 day before the operation, whereas the control group did not receive the preoperative nursing intervention. The patients in experience group also received education on the surgery team and the environment of operating room, the process of anesthesia, advantages of laparoscopic surgery, and the postoperative care from recovery room to discharge. The primary outcomes include State-Trait anxiety level and postoperative visual analogue scale. Secondary outcomes include total consumption of analgesics and postoperative complications.

RESULTS

Figure (a) will show the comparison of outcomes between 2 groups.

CONCLUSION

The preoperative nursing visit may decrease the anxiety and the complications after operation in patients receiving LC.

TRIAL REGISTRATION

This study protocol is registered in Research Registry (researchregistry5924).

摘要

背景

焦虑是一种由急性状况或触发因素引起的情绪障碍。它表现在自主神经系统的组成部分中,例如压力、焦虑、紧张和不适。大多数焦虑患者更加活跃、紧张,并且对各种刺激更加警觉。术后早期焦虑管理不当不仅会延长康复时间,还会增加其他并发症的风险。我们进行了一项随机临床试验,以研究护理访视对接受腹腔镜胆囊切除术(LC)患者术前焦虑和术后并发症的影响。

方法

这是一项单中心、安慰剂对照的随机试验,将于2020年8月至2020年12月进行。该试验按照随机研究的SPIRIT检查表进行。该研究已获得浙江省台州医院伦理委员会的批准(D20211-34)。本研究将纳入200例接受LC的患者。患者被随机分为两组:实验组(n = 100)或对照组(n = 100)。实验组在手术前1天对每位患者进行术前护理访视,而对照组未接受术前护理干预。实验组的患者还接受了关于手术团队和手术室环境、麻醉过程、腹腔镜手术的优势以及从恢复室到出院的术后护理的教育。主要结局包括状态-特质焦虑水平和术后视觉模拟评分。次要结局包括镇痛药的总消耗量和术后并发症。

结果

图(a)将显示两组之间结局的比较。

结论

术前护理访视可能会降低接受LC患者的焦虑和术后并发症。

试验注册

本研究方案已在研究注册库(researchregistry5924)中注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/78cf/7505285/f6a351f82268/medi-99-e22314-g001.jpg

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