Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Cardiothoracic Surgery Department, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
BMJ Open. 2023 Feb 16;13(2):e067082. doi: 10.1136/bmjopen-2022-067082.
Preoperative anxiety occurs at a very high rate in patients undergoing video-assisted thoracoscopic surgery (VATS). Moreover, it will result in poor mental state, more analgesic consumptions, rehabilitation delay and extra hospitalisation costs. Transcutaneous electrical acupoints stimulation (TEAS) is a convenient intervention for pain control and anxiety reduction. Nevertheless, TEAS efficacy of preoperative anxiety in VATS is unknown.
This single-centre randomised sham-controlled trial will be conducted in cardiothoracic surgery department of the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine in China. A total of 92 eligible participants with pulmonary nodules (size ≥8 mm) who are arranged for VATS will be randomly assigned to a TEAS group and a sham TEAS (STEAS) group in a 1:1 ratio. Daily TEAS/STEAS intervention will be administered starting on 3 days before the VATS and continued once per day for three consecutive days. The primary outcome will be the generalised anxiety disorder scale score change between the day before surgery with the baseline. The secondary outcomes will include serum concentrations of 5-hydroxytryptamine, norepinephrine and gamma-aminobutyric acid, intraoperative anaesthetic consumption, time to postoperative chest tube removal, postoperative pain, and length of postoperative hospital stay. The adverse events will be recorded for safety evaluation. All data in this trial will be analysed by the SPSS V.21.0 statistical software package.
Ethics approval was obtained from the Ethics Committee of the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine (approval number: 2021-023). The results of this study will be distributed through peer-reviewed journals.
NCT04895852.
在接受电视辅助胸腔镜手术（VATS）的患者中，术前焦虑的发生率非常高。此外，它会导致精神状态不佳、镇痛药消耗增加、康复延迟和额外的住院费用。经皮穴位电刺激（TEAS）是一种控制疼痛和减轻焦虑的便捷干预措施。然而，TEAS 对 VATS 术前焦虑的疗效尚不清楚。
本研究将在中国岳阳中西医结合医院心胸外科进行一项单中心随机对照假刺激试验。共有 92 名符合条件的肺结节（大小≥8mm）患者将被随机分配到 TEAS 组和假 TEAS（STEAS）组，比例为 1:1。从 VATS 前 3 天开始，每天进行一次 TEAS/STEAS 干预，连续进行 3 天。主要结局将是手术前一天与基线相比的广泛性焦虑障碍量表评分变化。次要结局包括血清 5-羟色胺、去甲肾上腺素和γ-氨基丁酸浓度、术中麻醉药消耗、术后胸管拔除时间、术后疼痛和术后住院时间。将记录不良反应以进行安全性评估。本试验中的所有数据均采用 SPSS V.21.0 统计软件包进行分析。
本研究已获得上海中医药大学岳阳中西医结合医院伦理委员会的批准（批准号：2021-023）。本研究结果将通过同行评议期刊发表。
NCT04895852。
