Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2024-12-20
2026-03-10
Brief Summary
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Detailed Description
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Modern studies report that surgical trauma, pain, sleep disorders, and stress responses increases inflammatory factors such as TNF-α and IL-6, and cause inflammation. This results in a decrease in the production of the monoamine neurotransmitters serotonin and norepinephrine in the brain, which causes depression. Therefore, the antidepressant drugs widely used in clinical practice are serotonin reuptake inhibitors; however, they are not only expensive and slow to act, but also have various side reactions, such as decreased libido, sexual dysfunction, headache, gastrointestinal symptoms, irritability, and anxiety. Further, long-term use may also cause damage to the nervous system.
Transcutaneous acupoint electrical stimulation (TAES) is an innovative diagnostic and therapeutic technique used in traditional Chinese medicine that integrates transcutaneous nerve electrical stimulation with meridian acupoints. It offers numerous advantages, such as being noninvasive, painless, simple to operate, with high treatment compliance, and minimal side effects. Multiple studies have shown that TAES not only has analgesic, anti-stress, and anti-inflammatory effects and can improve postoperative sleep disorders but can also directly increase the concentration of serotonin in the brain. Therefore, TAES may effectively improve post-VATS depression symptoms. This prospective, randomized, controlled, double blind, single-arm, single-center study will provide insights oninto the safety and effectiveness of TAES in improving post-VATS.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group T
the electrodes will be fixed at acupointsShenmen,Neiguan,Hegu,Chize,Anmian bilaterally
Transcutaneous electrical acupoint stimulation
After entering the operating room, an experienced traditional Chinese medicine doctor will locate the bilateral Shenmen, Neiguan, Hegu, Chize, and Anmian acupoints, and sham acupoints. The target treatment acupoints will be wiped with 75% ethanol, and after the ethanol had evaporated, electrode pads (50 × 50 mm) will be placed and fixed according to the different groups. Thirty minutes before anesthesia, a TAES stimulator (Hwato Electronic Acupuncture Treatment Instrument, model no: SDZ-III; Suzhou Medical Appliances Co. Ltd, Suzhou, China) will be connected with a frequency setting of 2/10 Hz (2 Hz for 10 s and 10 Hz for 5 s), in dense-disperse mode. The current intensity will be set according to the patient's maximum tolerance and muscle twitching and continued until the end of the surgery.
Group S
the electrode pads will be fixed at the bilateral sham acupoints
Sham-TAES
After entering the operating room, an experienced traditional Chinese medicine doctor will locate the bilateral sham acupoints. The Sham acupoints is 4 cm interior to the bilateral Shenmen, Neiguan, Hegu, Chize, and Anmian acupoints. The sham acupoints will be wiped with 75% ethanol, and after the ethanol had evaporated, electrode pads (50 × 50 mm) will be placed and fixed according to the different groups. Thirty minutes before anesthesia, a TAES stimulator (Hwato Electronic Acupuncture Treatment Instrument, model no: SDZ-III; Suzhou Medical Appliances Co. Ltd, Suzhou, China) will be connected with a frequency setting of 2/10 Hz (2 Hz for 10 s and 10 Hz for 5 s), in dense-disperse mode. The current intensity will be set according to the patient's maximum tolerance and muscle twitching and continued until the end of the surgery
Interventions
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Transcutaneous electrical acupoint stimulation
After entering the operating room, an experienced traditional Chinese medicine doctor will locate the bilateral Shenmen, Neiguan, Hegu, Chize, and Anmian acupoints, and sham acupoints. The target treatment acupoints will be wiped with 75% ethanol, and after the ethanol had evaporated, electrode pads (50 × 50 mm) will be placed and fixed according to the different groups. Thirty minutes before anesthesia, a TAES stimulator (Hwato Electronic Acupuncture Treatment Instrument, model no: SDZ-III; Suzhou Medical Appliances Co. Ltd, Suzhou, China) will be connected with a frequency setting of 2/10 Hz (2 Hz for 10 s and 10 Hz for 5 s), in dense-disperse mode. The current intensity will be set according to the patient's maximum tolerance and muscle twitching and continued until the end of the surgery.
Sham-TAES
After entering the operating room, an experienced traditional Chinese medicine doctor will locate the bilateral sham acupoints. The Sham acupoints is 4 cm interior to the bilateral Shenmen, Neiguan, Hegu, Chize, and Anmian acupoints. The sham acupoints will be wiped with 75% ethanol, and after the ethanol had evaporated, electrode pads (50 × 50 mm) will be placed and fixed according to the different groups. Thirty minutes before anesthesia, a TAES stimulator (Hwato Electronic Acupuncture Treatment Instrument, model no: SDZ-III; Suzhou Medical Appliances Co. Ltd, Suzhou, China) will be connected with a frequency setting of 2/10 Hz (2 Hz for 10 s and 10 Hz for 5 s), in dense-disperse mode. The current intensity will be set according to the patient's maximum tolerance and muscle twitching and continued until the end of the surgery
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Fuling Central Hospital of Chongqing City
OTHER
Responsible Party
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Locations
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Fuling Central Hospital of Chongqing
Fuling, Chongqing Municipality, China
Countries
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Central Contacts
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Xiang Zou, M.D.
Role: CONTACT
Phone: +8613996812330
Facility Contacts
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Lin Gan, M.D.
Role: primary
References
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He Y, Yuan M, He C, Zhu D, Wang F. The Effects of Transcutaneous Acupoint Electrical Stimulation on Cancer-related Fatigue and Negative Emotions in Cancer Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Contrast Media Mol Imaging. 2022 Jul 31;2022:1225253. doi: 10.1155/2022/1225253. eCollection 2022.
Tsay SL, Cho YC, Chen ML. Acupressure and Transcutaneous Electrical Acupoint Stimulation in improving fatigue, sleep quality and depression in hemodialysis patients. Am J Chin Med. 2004;32(3):407-16. doi: 10.1142/S0192415X04002065.
Wang H, Yang BZ, Guo Q, Jing ZY. [Effect of transcutaneous electrical acupoint stimulation combined with epidural labor analgesia on postpartum depression]. Zhen Ci Yan Jiu. 2021 Mar 25;46(3):231-4. doi: 10.13702/j.1000-0607.200249. Chinese.
Chen WY, Li L, Wang HY, Jiang N. [Effects of Transcutaneous Electrical Acupoint Stimulation for Depression in Late Pregnancy and Impacts on Inflammatory Cytokines]. Zhen Ci Yan Jiu. 2018 Jan 25;43(1):44-8. doi: 10.13702/j.1000-0607.160781. Chinese.
Agrawal S, Szmit M, Welna M, Rudnicki J, Agrawal A, Gozdzik W. Transcutaneous electrical acupoint stimulation to reduce opioid consumption in patients undergoing inguinal hernia repair: protocol for a randomized controlled trial. Trials. 2022 Dec 29;23(1):1064. doi: 10.1186/s13063-022-07019-9.
Chen J, Zhang Y, Li X, Wan Y, Ji X, Wang W, Kang X, Yan W, Fan Z. Efficacy of transcutaneous electrical acupoint stimulation combined with general anesthesia for sedation and postoperative analgesia in minimally invasive lung cancer surgery: A randomized, double-blind, placebo-controlled trial. Thorac Cancer. 2020 Apr;11(4):928-934. doi: 10.1111/1759-7714.13343. Epub 2020 Feb 16.
Song B, Chang Y, Li Y, Zhu J. Effects of Transcutaneous Electrical Acupoint Stimulation on the Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery: A Prospective, Randomized Controlled Trial. Nat Sci Sleep. 2020 Oct 27;12:809-819. doi: 10.2147/NSS.S270739. eCollection 2020.
Ulett GA, Han S, Han JS. Electroacupuncture: mechanisms and clinical application. Biol Psychiatry. 1998 Jul 15;44(2):129-38. doi: 10.1016/s0006-3223(97)00394-6.
Duan D, Tu Y, Yang X, Liu P. Electroacupuncture Restores 5-HT System Deficit in Chronic Mild Stress-Induced Depressed Rats. Evid Based Complement Alternat Med. 2016;2016:7950635. doi: 10.1155/2016/7950635. Epub 2016 Nov 23.
Yan LP, Liu YG, Wu XT, Li SD, Ma C. [Effect of electroacupuncture intervention on N-methyl-D-aspartic acid receptor expression in spinal cord in rats with chronic constrictive injury of the sciatic nerve]. Zhen Ci Yan Jiu. 2013 Oct;38(5):380-5. Chinese.
Qiao LN, Yang YS, Wang JY, Gao YH, Han YJ, Chen SP, Ji CF, Liu JL. [Effects of electroacupuncture at "Futu" (LI 18), etc. on expression of spinal 5-HT 1 AR mRNA, 5-HT 2 AR mRNA and protein in rats with neck incision pain]. Zhen Ci Yan Jiu. 2011 Dec;36(6):391-6. Chinese.
Wu ZJ, Cai RL, He L, Ma Y, Hu WB, Wang KM. [Effects of electroacupuncture stimulation of "Neiguan" (PC 6) and "Shenmen" (HT7) on contents of 5-hydroxytryptamine in hypothalamic paraventricular nucleus region and serum in hyperlipidemia rats with acute myocardial infarction]. Zhen Ci Yan Jiu. 2013 Dec;38(6):482-7. Chinese.
Liu X, Li S, Wang B, An L, Ren X, Wu H. Intraoperative and postoperative anaesthetic and analgesic effect of multipoint transcutaneous electrical acupuncture stimulation combined with sufentanil anaesthesia in patients undergoing supratentorial craniotomy. Acupunct Med. 2015 Aug;33(4):270-6. doi: 10.1136/acupmed-2014-010749. Epub 2015 Apr 29.
Marwaha S, Palmer E, Suppes T, Cons E, Young AH, Upthegrove R. Novel and emerging treatments for major depression. Lancet. 2023 Jan 14;401(10371):141-153. doi: 10.1016/S0140-6736(22)02080-3. Epub 2022 Dec 16.
Ting EY, Yang AC, Tsai SJ. Role of Interleukin-6 in Depressive Disorder. Int J Mol Sci. 2020 Mar 22;21(6):2194. doi: 10.3390/ijms21062194.
Colucci-D'Amato L, Speranza L, Volpicelli F. Neurotrophic Factor BDNF, Physiological Functions and Therapeutic Potential in Depression, Neurodegeneration and Brain Cancer. Int J Mol Sci. 2020 Oct 21;21(20):7777. doi: 10.3390/ijms21207777.
Wei W, Huang X, Zhu J. Effect of Acupoint Therapies on Postoperative Sleep Quality: A Narrative Review. Med Sci Monit. 2023 Feb 10;29:e938920. doi: 10.12659/MSM.938920.
Schinz K, Steigerwald L, Mantsopoulos K, Gostian AO, Traxdorf M, Sievert M, Rupp R, Iro H, Mueller SK. Depression and female gender associated with higher postoperative pain scores after sinonasal surgery. Acta Otolaryngol. 2022 Jan;142(1):73-77. doi: 10.1080/00016489.2021.2012254. Epub 2021 Dec 23.
Sullivan DR, Forsberg CW, Ganzini L, Au DH, Gould MK, Provenzale D, Slatore CG. Longitudinal Changes in Depression Symptoms and Survival Among Patients With Lung Cancer: A National Cohort Assessment. J Clin Oncol. 2016 Nov 20;34(33):3984-3991. doi: 10.1200/JCO.2016.66.8459. Epub 2016 Oct 31.
O'Gara B, Espinosa Leon JP, Robinson K, Schaefer M, Talmor D, Fischer M. New onset postoperative depression after major surgery: an analysis from a national claims database. BJA Open. 2023 Sep 21;8:100223. doi: 10.1016/j.bjao.2023.100223. eCollection 2023 Dec.
Cheng X, Wang H, Diao M, Jiao H. Effect of S-ketamine on Postoperative Quality of Recovery in Patients Undergoing Video-Assisted Thoracic Surgery. J Cardiothorac Vasc Anesth. 2022 Aug;36(8 Pt B):3049-3056. doi: 10.1053/j.jvca.2022.04.028. Epub 2022 Apr 26.
Zhou Jian SX, Xiaoyi H, Xiang L, He L, Junli C. Effects of mecobalamin combined with ropivacaine for intercostal nerve block on the postoperative depression in patients undergoing thoracoscopic surgery. J Xuzhou Med Univ. 2021;41:189-93
Gan SL, Long YQ, Wang QY, Feng CD, Lai CX, Liu CT, Ding YY, Liu H, Peng K, Ji FH. Effect of esketamine on postoperative depressive symptoms in patients undergoing thoracoscopic lung cancer surgery: A randomized controlled trial. Front Psychiatry. 2023 Mar 15;14:1128406. doi: 10.3389/fpsyt.2023.1128406. eCollection 2023.
Other Identifiers
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TAES for VATS depression
Identifier Type: -
Identifier Source: org_study_id