Efficacy and safety of transcutaneous electrical acupoints stimulation for preoperative anxiety in thoracoscopic surgery: study protocol for a randomised controlled trial.

Abstract

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.