Trials / Not Yet Recruiting
Not Yet RecruitingNCT06718231
TAES Alleviate Post-VATS Depression
Transcutaneous Electrical Acupoint Stimulation Alleviate Postoperative Depression in Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Fuling Central Hospital of Chongqing City · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Depression can significantly affect postoperative rehabilitation quality and increase the mortality of patients who receive video-assisted thoracoscopic surgery (VATS). This study intend to evaluate the transcutaneous electrical acupoint stimulation (TEAS) of VATS safety and the efficacy of the postoperative depression compared to a sham group.
Detailed description
Depression is a common psychiatric problem in perioperative period in patients who receive video-assisted thoracoscopic surgery (VATS). Multiple research have pointed out that the incidence of postoperative depression can be as high as 11.8%-34% . Brian et al.reported that the iIncidence of new depressive episodes one year after VATS was as high as 12.4%. Depression not only reduces treatment compliance and quality of life, prolongs hospital stays, and increases postoperati''ve mortality, but can also exacerbate pain and reduce sleep quality, significantly affecting postoperative recovery . 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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
| BEHAVIORAL | 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 |
Timeline
- Start date
- 2024-12-20
- Primary completion
- 2026-01-20
- Completion
- 2026-03-10
- First posted
- 2024-12-05
- Last updated
- 2024-12-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06718231. Inclusion in this directory is not an endorsement.