An interventional study of Transcutaneous electrical acupoint stimulation and Sham-TAES in Depression After Video-assisted Thoracoscopic Surgery, sponsored by Fuling Central Hospital of Chongqing City. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by Fuling Central Hospital of Chongqing City · Not applicable, Interventional, and Supportive care
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 120 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Fuling Central Hospital of Chongqing City is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Unilateral VATS performed under general anesthesia due to pulmonary nodules; The age ranged from 18 to 65 years; American Society of Anesthesiologists (ASA) classification II-III; The patient has normal consciousness, with no facial paralysis, is capable of cooperating with treatment, and provides signed informed consent.
Exclusion Criteria:
Merge the skin of local acupoint infectors; Patients with upper extremity nerve injury; Patients with implanted pacemakers; Alcoholism or long-term use of opioid, hormonal, and anti-inflammatory analgesics; Allergic to the drug used in the study; Those who recently received TAES or acupoint treatment; Patients with history of psychiatric disorders or current use of psychiatric medication; Receiving treatment with monoamine oxidase inhibitors; Severe disease of the heart, brain, liver, kidneys, or hematopoietic system; Patients unable to cooperate with the study for any reason
the electrodes will be fixed at acupointsShenmen,Neiguan,Hegu,Chize,Anmian bilaterally
Behavioral: Transcutaneous electrical acupoint stimulation
the electrode pads will be fixed at the bilateral sham acupoints
Behavioral: Sham-TAES
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.
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
Beck Depression Inventory score 30 days postoperatively
The self-rating Scale for Depression consists of 21 groups of questions, each group has 4 statements, and each sentence corresponds to an Arabic numeral.Participants choose the statement that best suits their situation according to their own feeling.After all 21 groups have been completed, the total score of each group is added
Time frame: 30 days postoperatively
Beck Depression Inventory score 2 days postoperatively
The self-rating Scale for Depression consists of 21 groups of questions, each group has 4 statements, and each sentence corresponds to an Arabic numeral.Participants choose the statement that best suits their situation according to their own feeling.After all 21 groups have been completed, the total score of each group is added
Time frame: 2 days postoperatively
Serum Interleukin-6 concentration 2 days after surgery
Enzyme-linked immunosorbent assay was used to measure serum interleukin-6 concentration 2 days after surgery
Time frame: 2 days after surgery
Serum tumor necrosis factor-α concentration 2 days after surgery
Enzyme-linked immunosorbent assay was used to measure serum tumor necrosis factor-α concentration 2 days after surgery
Time frame: 2 days after surgery
24h postoperative resting pain numerical rating scale (NRS) score
The Numeric Rating Scale is used to assess pain.Ask participant to rate based on how they feel pain.0 is painless and 10 is the most severe pain
Time frame: 24 hours after surgery
48h postoperative resting pain numerical rating scale (NRS) score
The Numeric Rating Scale is used to assess pain.Ask participant to rate based on how they feel pain.0 is painless and 10 is the most severe pain
Time frame: 48 hours after surgery
24h postoperative moving NRS pain score
The Numeric Rating Scale is used to assess pain.Ask participant to rate based on how they feel pain.0 is painless and 10 is the most severe pain
Time frame: 24 hours after surgery
48h postoperative moving NRS pain score
The Numeric Rating Scale is used to assess pain.Ask participant to rate based on how they feel pain.0 is painless and 10 is the most severe pain
Time frame: 48 hours after surgery
Dosage of patient controlled intravenous analgesia 24h after surgery
patient controlled intravenous analgesia record
Time frame: 24 hours after surgery
Dosage of patient controlled intravenous analgesia 48h after surgery
patient controlled intravenous analgesia record
Time frame: 48 hours after surgery
Sleep NRS score 2 days after surgery
A Numeric Rating Scale was used to assess sleep quality. Participants were asked to rate how well they slept. 0 is good sleep and 10 is unable to sleep at all
Time frame: 2 days after sergury
TAES-related complications
dermatitis, allergic reactions, dizziness,drowsiness
Time frame: 2 days after sergury
Plan to share: No — To protect patient privacy, we consider keeping the data private.After the study concludes, the raw data and research findings will be reported to the Research Management Committee.the original data will be available from the researchers via email through official channels.
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Fuling Central Hospital of Chongqing City