Anxiety Clinical Trial
Official title:
Efficacy and Safety of Transcutaneous Electrical Acupoints Stimulation for Preoperative Anxiety in Thoracoscopic Surgery: Study Protocol for a Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 92 |
Est. completion date | December 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion criteria 1. Those diagnosed as pulmonary nodules requiring VATS. 2. Age between 18 and 75 years old. 3. 4 = GAD-7 score = 9 and those who have no previous mental illness and have not used anti-anxiety or psychotropic drugs within 2 weeks. 4. Those who have clear consciousness, normal understanding, no expression barriers, can cooperate with treatment and have signed an informed consent. 5. Patients who have not received TEAS treatment in the past. 6. Patients who have not participated or participating in other clinical trials one month before enrollment. Exclusion criteria 1. Patients with skin infections in local meridian points. 2. Patients with upper or lower limb nerve injury. 3. Patients who had been implanted pacemaker. Rejection, suspension and dropout criteria 1. Those with serious adverse reactions. 2. Those who presented worsen symptoms or life-threatening illnesses that cannot be continued during treatment. 3. The principal investigator asserts that there are unacceptable risks for serious adverse events during the study. 4. Patients who cannot cooperate to complete the research plan, including language difficulties, infectious diseases and other medical history. 5. Patients quit by themselves. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Yueyang Integrated Medicine Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Yueyang Integrated Medicine Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score change of Generalized Anxiety Scale (GAD-7) | 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. | up to 3 days before surgery | |
Secondary | 5-HT(µmol/L) | The blood of each group of patients was collected on the third day before the treatment and the day before the operation, and the levels of neurotransmitter indexes (5-HT, NE, GABA) in the peripheral blood were detected by the immunoturbidimetric method. | on the third day before the treatment and the day before the operation | |
Secondary | NE(µg/L) | The blood of each group of patients was collected on the third day before the treatment and the day before the operation, and the levels of neurotransmitter indexes (5-HT, NE, GABA) in the peripheral blood were detected by the immunoturbidimetric method. | on the third day before the treatment and the day before the operation | |
Secondary | GABA(µmol/L) | The blood of each group of patients was collected on the third day before the treatment and the day before the operation, and the levels of neurotransmitter indexes (5-HT, NE, GABA) in the peripheral blood were detected by the immunoturbidimetric method. | on the third day before the treatment and the day before the operation | |
Secondary | Chest tube removal time | Record the time from the end of surgery to the removal of chest tube. | up to 168 hours after surgery | |
Secondary | Postoperative pain | VAS ranges from 0 (no pain) to 10 (unbearable pain). A change of 10 for the 100mm pain VAS signify a clinically important improvement or deterioration. Participants will be asked to describe their average surgical incision intensity in the 48 hours after surgery. | up to 2 days after surgery | |
Secondary | Length of postoperative hospital stay | The length of postoperative stay will be recorded. | up to 14 days after surgery | |
Secondary | Intraoperative anesthetic consumption | The types and cumulative doses of intraoperative analgesics will be assessed. | From the beginning to the end of the surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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