Clinical Study of TEAS Intervention in Relieving Anxiety Before Thoracoscopic Surgery

NCT04895852 | Unknown DMC

• 1 other identifier: 20210427
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center randomized sham-controlled trial will be conducted in cardiothoracic surgery department of the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine in China. A total of 92 eligible participants with pulmonary nodules (size ≥ 8mm) who will undergo VATS will be randomly allocated to a TEAS group and a sham TEAS (STEAS) group in a 1:1 ratio. Daily TEAS/STEAS treatment will be performed starting on 3 days before the VATS and continued for three consecutive days, once per day. The primary outcome will be the minimal clinically important difference of generalized anxiety disorder scale score change between the day before surgery with the baseline. The secondary outcomes include serum concentrations of 5-hydroxytryptamine, norepinephrine and gamma-aminobutyric acid, intraoperative anesthetic consumption, time to postoperative chest tube removal, postoperative pain, length of postoperative hospital stay. The adverse events will be recorded for safety evaluation. All data in the study will be analyzed using the SPSS 21.0 statistical software package.

Conditions

Acupuncture Therapy; Preoperative Period; Anxiety; Thoracoscopic Surgery

Keywords

Acupuncture Treatment; Preoperative Conditioning; Anxiety; Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• Score change of Generalized Anxiety Scale (GAD-7)

  Add the scores of each of the 7 items to get the total score; among them, 0-4 points for no anxiety, 5-9 points for possible mild anxiety, 10-14 points for possible moderate anxiety, 15 Scores above are likely to have severe anxiety. The GAD-7 scores' Change between three days before and the day before surgery will be recorded.

  up to 3 days before surgery

Secondary Outcomes (7)

• 5-HT（µmol/L）

  on the third day before the treatment and the day before the operation

• NE（µg/L）

  on the third day before the treatment and the day before the operation

• GABA（µmol/L）

  on the third day before the treatment and the day before the operation

• Chest tube removal time

  up to 168 hours after surgery

• Postoperative pain

  up to 2 days after surgery

Study Arms (2)

TEAS group

EXPERIMENTAL

30 minutes TEAS therapy on DU20, EX-HN3, LI4, LR3 once per day for three days before surgery.

Device: TEAS

Control group

SHAM COMPARATOR

The control group selects the same acupoints as the TEAS group and other intervention measures are the same as the TEAS group except for the current intensity is set to 0-mA.

Device: Sham TEAS

Interventions

TEAS DEVICE

The self-adhesive gel electrode pad will be placed at the center of DU20 (Baihui), EX-HN3 (Yintang) and both sides of LI4 (Hegu), LR3 (Taichong) in strict accordance with the World Health Organization Standardized Acupuncture Location. Electric stimulation will be used with a TEAS apparatus (HANS200A Beijing Huawei Co., LTD.) . The frequency of the electrical stimulation will be set as alternating 2/100Hz to relieve anxiety. The current intensity will be adjusted individually, starting at 1 mA and increasing gradually until the patient can perceive and tolerate it (preferably slight twitching of local muscles without pain).

TEAS group

Sham TEAS DEVICE

The STEAS group selects the same acupoints as the TEAS group and other intervention measures are the same as the TEAS group except for the current intensity is set to 0-mA. The acupuncturist responsible for the operation will tell patients in STEAS group that this is a type of stimulus without perception.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those diagnosed as pulmonary nodules requiring VATS.
• Age between 18 and 75 years old.
• ≤ GAD-7 score ≤ 9 and those who have no previous mental illness and have not used anti-anxiety or psychotropic drugs within 2 weeks.
• Those who have clear consciousness, normal understanding, no expression barriers, can cooperate with treatment and have signed an informed consent.
• Patients who have not received TEAS treatment in the past.
• Patients who have not participated or participating in other clinical trials one month before enrollment.

You may not qualify if:

• Patients with skin infections in local meridian points.
• Patients with upper or lower limb nerve injury.
• Patients who had been implanted pacemaker.
• Rejection, suspension and dropout criteria
• Those with serious adverse reactions.
• Those who presented worsen symptoms or life-threatening illnesses that cannot be continued during treatment.
• The principal investigator asserts that there are unacceptable risks for serious adverse events during the study.
• Patients who cannot cooperate to complete the research plan, including language difficulties, infectious diseases and other medical history.
• Patients quit by themselves.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Study Sites (1)

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, China

RECRUITING

Related Publications (1)

• Wu X, Chen T, Wang K, Wei X, Feng J, Zhou J. Efficacy and safety of transcutaneous electrical acupoints stimulation for preoperative anxiety in thoracoscopic surgery: study protocol for a randomised controlled trial. BMJ Open. 2023 Feb 16;13(2):e067082. doi: 10.1136/bmjopen-2022-067082.

  PMID: 36797022 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jia Zhou

  Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

  STUDY DIRECTOR

Central Study Contacts

Xindi Wu

CONTACT

021-65161782; cindywu1111@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 20, 2021
• Study Start: January 11, 2023
• Primary Completion: March 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 11, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within five years of publication of the trial.
• Access Criteria: Reasonable requests for IPD data can be obtained by contacting the investigator.

Locations

CN (1)