Clinical Study of TEAS Intervention in Relieving Anxiety Before Thoracoscopic Surgery

This single center, randomized, sham-controlled, participant-blinded and assessor-blinded trial will be conducted at the inpatient ward of cardiothoracic surgery department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine. The trial will commence after ethical approval has been obtained and the protocol has been registered. Patient enrollment started in late June 2021 and is expected to end in March 2023. An estimated 92 participants will be recruited and randomly assigned to receive TEAS or sham TEAS (STEAS) in a l:l ratio using SPSS 21.0 software. During the development of the standard protocol, the Standards for Reporting Interventions in Clinical Trials for Acupuncture (STRICTA) and the SPIRIT reporting guidelines will be followed to explicitly and transparently explain the therapeutic processes involved. Patients who will undergo VATS for pulmonary nodules will be screened. . Potential subjects will be interviewed preoperatively by the clinical research coordinator to assess whether they meet the inclusion and exclusion criteria. Eligible participants will voluntarily provide written informed consent prior to randomization. This study will have a single-blind design. The patients are blinded to the group assignment and are told that they might or might not feel a sensation when the TEAS is working. Both acupoint stimulations in the TEAS group and in the STEAS group will be performed by the same acupuncturist who is not involved in the process of data collection. The TEAS instrument is covered with an opaque box for adequate blinding. The randomized numbers were generated with SPSS 21.0 (IBM®SPSS®Statistics, Version 21) software. The random sequence for group classification will be sealed in a confidential envelope. Patients will be randomly allocated into the TEAS group or STEAS group at a ratio of 1:1. Group assignment was exposed from a sealed envelope only by an acupuncturist. Patients will be treated separately to prevent communication. Efficacy evaluation will be conducted blinded to the grouping allocation. The efficacy evaluators and statisticians will be separated and blinded. To test the participant-blinding effects, all participants will be asked to guess whether they had received TEAS or STEAS within 5 minutes after one of the treatment sessions before VATS.