TAES Alleviate Post-VATS Depression (TAES)

December 4, 2024 updated by: Fuling Central Hospital of Chongqing City

Transcutaneous Electrical Acupoint Stimulation Alleviate Postoperative Depression in Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jun hua Zhang, M.D.
  • Phone Number: +8615213680591
  • Email: okzjh000@163.com

Study Contact Backup

  • Name: Xiang Zou, M.D.
  • Phone Number: +8613996812330

Study Locations

  • China
    • Chongqing
      • Fuling, Chongqing, China, 408000
        • Fuling Central Hospital of Chongqing
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group T
the electrodes will be fixed at acupointsShenmen,Neiguan,Hegu,Chize,Anmian bilaterally
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.
Sham Comparator: Group S
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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory score 30 days postoperatively
Time Frame: 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
30 days postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuling Central Hospital of Chongqing City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2024

Primary Completion (Estimated)

January 20, 2026

Study Completion (Estimated)

March 10, 2026

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 4, 2024

First Posted (Estimated)

December 5, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAES for VATS depression

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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