TAES Alleviate Post-VATS Depression

Not Applicable

Not yet recruiting

• Conditions: Depression After Video-assisted Thoracoscopic Surgery

• Registration Number: NCT06718231
• Lead Sponsor: Fuling Central Hospital of Chongqing City

Brief 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Study Start: 2024-12-20
• Primary Completion: 2026-01-20
• Study Completion: 2026-03-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory score 30 days postoperatively	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

Secondary Outcome Measures

Name	Time	Method
Serum tumor necrosis factor-α concentration 2 days after surgery	2 days after surgery	Enzyme-linked immunosorbent assay was used to measure serum tumor necrosis factor-α concentration 2 days after surgery
Beck Depression Inventory score 2 days postoperatively	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
Serum Interleukin-6 concentration 2 days after surgery	2 days after surgery	Enzyme-linked immunosorbent assay was used to measure serum interleukin-6 concentration 2 days after surgery
24h postoperative resting pain numerical rating scale (NRS) score	24 hours after surgery	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
48h postoperative resting pain numerical rating scale (NRS) score	48 hours after surgery	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
24h postoperative moving NRS pain score	24 hours after surgery	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
48h postoperative moving NRS pain score	48 hours after surgery	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
Dosage of patient controlled intravenous analgesia 24h after surgery	24 hours after surgery	patient controlled intravenous analgesia record
Dosage of patient controlled intravenous analgesia 48h after surgery	48 hours after surgery	patient controlled intravenous analgesia record
Sleep NRS score 2 days after surgery	2 days after sergury	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
TAES-related complications	2 days after sergury	dermatitis, allergic reactions, dizziness,drowsiness

Trial Locations

Locations (1)

Fuling Central Hospital of Chongqing; 🇨🇳 Fuling, Chongqing, China