Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Trials. 2022 Apr 27;23(1):364. doi: 10.1186/s13063-022-06165-4.
Gastroscopy procedures are frequently performed under general sedation to minimize discomfort. Patients who refuse a sedative injection may experience more discomfort and adverse reactions such as pain and nausea. These instances reduce patient compliance and willingness to participate in future procedures. Acupuncture has been shown to have an anti-nausea and analgesic effect; however, there is limited data available that demonstrates the efficacy of acupuncture when applied before gastroscopy.
A total of 60 participants will be randomly assigned to the electroacupuncture (EA) group and the sham electroacupuncture (SEA) group at a ratio of 1:1. Acupuncture treatment will be performed before gastroscopy for a duration of 30 min. All patients will complete detailed questionnaires at 30 min and 7 days post-procedure to record the severity of their symptoms. The primary outcome will be the average of 4 standard visual analogue scale (VAS) scores in the categories of nausea, vomiting, throat discomfort, and agitation as reported by the patient. The secondary outcomes will be patient's anxiety level as recorded by the 6-item short form of the State-Trait Anxiety Inventory (STAI-S6) and Amsterdam Pre-Operative Anxiety and Information Scale (APAIS), preference in a future endoscopy, pulse oxygen saturation (SpO2), heart rate (HR), and blood pressure (BP). Anxiety scales will be assessed before and after acupuncture; others will be completed at 30 min and 7 days post-procedure. The duration of the gastroscopy and the number of biopsies will be recorded after operation.
This randomized controlled trial will explore the feasibility of the further clinical application of electroacupuncture for the improvement of patient discomfort during gastroscopy without systemic sedation.
ChiCTR2000040726 . This trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2020SHL-KY-11). Registration date 12 August 2020.
为了减轻患者的不适，胃镜检查通常在全身镇静下进行。拒绝接受镇静剂注射的患者可能会感到更不适，并出现疼痛和恶心等不良反应。这些情况会降低患者的依从性和参与未来检查的意愿。针灸具有止吐和镇痛作用；然而，目前可用的数据有限，无法证明在胃镜检查前应用针灸的疗效。
将 60 名参与者以 1:1 的比例随机分配到电针（EA）组和假电针（SEA）组。针刺治疗将在胃镜检查前进行 30 分钟。所有患者将在检查后 30 分钟和 7 天完成详细的问卷，记录症状的严重程度。主要结果将是患者报告的恶心、呕吐、喉咙不适和烦躁 4 个标准视觉模拟量表（VAS）评分的平均值。次要结果将是患者焦虑水平，由状态特质焦虑量表（STAI-S6）和阿姆斯特丹术前焦虑和信息量表（APAIS）的 6 项简短形式记录，对未来内镜检查的偏好，脉搏血氧饱和度（SpO2）、心率（HR）和血压（BP）。针刺前和针刺后评估焦虑量表；其他将在检查后 30 分钟和 7 天完成。术后记录胃镜检查持续时间和活检次数。
这项随机对照试验将探讨在不进行全身镇静的情况下，电针对改善胃镜检查患者不适的进一步临床应用的可行性。
ChiCTR2000040726。该试验已获得上海市中医医院伦理委员会的批准（2020SHL-KY-11）。注册日期 2020 年 8 月 12 日。
