Efficacy and Safety of Transcutaneous Electrical Acupoints Stimulation for Preoperative Anxiety in Thoracoscopic Surgery: Study Protocol for a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acupuncture Therapy
- Sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Score change of Generalized Anxiety Scale (GAD-7)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This single-center randomized 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 ≥ 8mm) who will undergo VATS will be randomly allocated to a TEAS group and a sham TEAS (STEAS) group in a 1:1 ratio. Daily TEAS/STEAS treatment will be performed starting on 3 days before the VATS and continued for three consecutive days, once per day. The primary outcome will be the minimal clinically important difference of generalized anxiety disorder scale score change between the day before surgery with the baseline. The secondary outcomes include serum concentrations of 5-hydroxytryptamine, norepinephrine and gamma-aminobutyric acid, intraoperative anesthetic consumption, time to postoperative chest tube removal, postoperative pain, length of postoperative hospital stay. The adverse events will be recorded for safety evaluation. All data in the study will be analyzed using the SPSS 21.0 statistical software package.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Score change of Generalized Anxiety Scale (GAD-7)
Time Frame: up to 3 days before surgery
Add the scores of each of the 7 items to get the total score; among them, 0-4 points for no anxiety, 5-9 points for possible mild anxiety, 10-14 points for possible moderate anxiety, 15 Scores above are likely to have severe anxiety. The GAD-7 scores' Change between three days before and the day before surgery will be recorded.
Secondary Outcomes
- GABA（µmol/L）(on the third day before the treatment and the day before the operation)
- Intraoperative anesthetic consumption(From the beginning to the end of the surgery)
- 5-HT（µmol/L）(on the third day before the treatment and the day before the operation)
- NE（µg/L）(on the third day before the treatment and the day before the operation)
- Chest tube removal time(up to 168 hours after surgery)
- Postoperative pain(up to 2 days after surgery)
- Length of postoperative hospital stay(up to 14 days after surgery)