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Depression After Video-assisted Thoracoscopic SurgeryTAESNCT06718231

TAES Alleviate Post-VATS Depression

A study testing Transcutaneous electrical acupoint stimulation in people with Depression After Video-assisted Thoracoscopic Surgery, run by Fuling Central Hospital of Chongqing City at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Transcutaneous electrical acupoint stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteChina
Study dates
20 Dec 2024to 10 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jun hua Zhang, M.D. contact

+8615213680591

okzjh000@163.com

Xiang Zou, M.D. contact

+8613996812330

China1 site
  • Fuling Central Hospital of Chongqing

    Fuling, Chongqing Municipality, 408000

    Lin Gan, M.D., +8615978998837, ganlindoctor@163.com

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Transcutaneous electrical acupoint stimulation, Sham-TAES
Keywords
Transcutaneous electrical acupoint stimulation (TAES), depression, video-assisted thoracoscopic surgery, interleukin-6, tumor necrosis factor-α
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous electrical acupoint stimulationBehavioural

    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-TAESBehavioural

    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

Study groups in NCT06718231
Study groupRoleWhat they receive
Group TActive comparatorthe electrodes will be fixed at acupointsShenmen,Neiguan,Hegu,Chize,Anmian bilaterally
Receives: Behavioral: Transcutaneous electrical acupoint stimulation
Group SSham comparatorthe electrode pads will be fixed at the bilateral sham acupoints
Receives: Behavioral: Sham-TAES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 days postoperatively

Secondary outcomes (11)
  1. 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

    Measured: 2 days postoperatively

  2. Serum Interleukin-6 concentration 2 days after surgery

    Enzyme-linked immunosorbent assay was used to measure serum interleukin-6 concentration 2 days after surgery

    Measured: 2 days after surgery

  3. 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

    Measured: 2 days after surgery

  4. 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

    Measured: 24 hours after surgery

  5. 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

    Measured: 48 hours after surgery

  6. 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

    Measured: 24 hours after surgery

  7. 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

    Measured: 48 hours after surgery

  8. Dosage of patient controlled intravenous analgesia 24h after surgery

    patient controlled intravenous analgesia record

    Measured: 24 hours after surgery

  9. Dosage of patient controlled intravenous analgesia 48h after surgery

    patient controlled intravenous analgesia record

    Measured: 48 hours after surgery

  10. 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

    Measured: 2 days after sergury

  11. TAES-related complications

    dermatitis, allergic reactions, dizziness,drowsiness

    Measured: 2 days after sergury

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2024
  2. Study start20 Dec 2024 (estimated)
  3. Primary completion20 Jan 2026 (estimated)
  4. Study completion10 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06718231
Sponsor's protocol ID
TAES for VATS depression
Acronym
TAES
Status last verified
Dec 2024
First submitted
2 Dec 2024
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 35965622
  • 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.

    PubMed 15344424
  • 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.

    PubMed 33798297
  • 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.

    PubMed 29383894
  • 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.

    PubMed 36581999
  • 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.

    PubMed 32062864
  • 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.

    PubMed 33154688
  • 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.

    PubMed 9646895
  • 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.

    PubMed 27994633
  • 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.

    PubMed 24308185
  • 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.

    PubMed 22379782
  • 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.

    PubMed 24579363
  • 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.

    PubMed 25926298
  • 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.

    PubMed 36535295
  • 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.

    PubMed 32235786

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous electrical acupoint stimulation in people with Depression After Video-assisted Thoracoscopic Surgery, run by Fuling Central Hospital of Chongqing City at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun hua Zhang, M.D. (+8615213680591, okzjh000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Depression Inventory score 30 days postoperatively (time frame: 30 days postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06718231, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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