Acupuncture TherapyNCT04895852
Clinical Study of TEAS Intervention in Relieving Anxiety Before Thoracoscopic Surgery
A study testing TEAS in people with Acupuncture Therapy and Preoperative Period, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acupuncture Therapy, Preoperative Period, Anxiety
- What is being tested?
- TEAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Those diagnosed as pulmonary nodules requiring VATS.
- Age between 18 and 75 years old.
- 4 ≤ 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Yueyang Integrated Medicine Hospital
Shanghai
Jia Zhou, 021-65161782, pdzhoujia@163.com
About this study
Official title: Efficacy and Safety of Transcutaneous Electrical Acupoints Stimulation for Preoperative Anxiety in Thoracoscopic Surgery: Study Protocol for a Randomized Controlled Trial
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.
Read the detailed description
This single center, randomized, sham-controlled, participant-blinded and assessor-blinded trial will be conducted at the inpatient ward of cardiothoracic surgery department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine. The trial will commence after ethical approval has been obtained and the protocol has been registered. Patient enrollment started in late June 2021 and is expected to end in March 2023. An estimated 92 participants will be recruited and randomly assigned to receive TEAS or sham TEAS (STEAS) in a l:l ratio using SPSS 21.0 software. During the development of the standard protocol, the Standards for Reporting Interventions in Clinical Trials for Acupuncture (STRICTA) and the SPIRIT reporting guidelines will be followed to explicitly and transparently explain the therapeutic processes involved.
Patients who will undergo VATS for pulmonary nodules will be screened. . Potential subjects will be interviewed preoperatively by the clinical research coordinator to assess whether they meet the inclusion and exclusion criteria. Eligible participants will voluntarily provide written informed consent prior to randomization.
This study will have a single-blind design. The patients are blinded to the group assignment and are told that they might or might not feel a sensation when the TEAS is working. Both acupoint stimulations in the TEAS group and in the STEAS group will be performed by the same acupuncturist who is not involved in the process of data collection. The TEAS instrument is covered with an opaque box for adequate blinding. The randomized numbers were generated with SPSS 21.0 (IBM®SPSS®Statistics, Version 21) software. The random sequence for group classification will be sealed in a confidential envelope. Patients will be randomly allocated into the TEAS group or STEAS group at a ratio of 1:1. Group assignment was exposed from a sealed envelope only by an acupuncturist. Patients will be treated separately to prevent communication. Efficacy evaluation will be conducted blinded to the grouping allocation. The efficacy evaluators and statisticians will be separated and blinded. To test the participant-blinding effects, all participants will be asked to guess whether they had received TEAS or STEAS within 5 minutes after one of the treatment sessions before VATS.
- Being tested
- TEAS, Sham TEAS
- Keywords
- Acupuncture Treatment, Preoperative Conditioning, Anxiety, Thoracoscopic Surgery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEASDevice
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).
Sham TEASDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TEAS group | Experimental | 30 minutes TEAS therapy on DU20, EX-HN3, LI4, LR3 once per day for three days before surgery. Receives: 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. Receives: Device: Sham TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 days before surgery
Secondary outcomes (7)
5-HT（µmol/L）
The blood of each group of patients was collected on the third day before the treatment and the day before the operation, and the levels of neurotransmitter indexes (5-HT, NE, GABA) in the peripheral blood were detected by the immunoturbidimetric method.
Measured: on the third day before the treatment and the day before the operation
NE（µg/L）
The blood of each group of patients was collected on the third day before the treatment and the day before the operation, and the levels of neurotransmitter indexes (5-HT, NE, GABA) in the peripheral blood were detected by the immunoturbidimetric method.
Measured: on the third day before the treatment and the day before the operation
GABA（µmol/L）
The blood of each group of patients was collected on the third day before the treatment and the day before the operation, and the levels of neurotransmitter indexes (5-HT, NE, GABA) in the peripheral blood were detected by the immunoturbidimetric method.
Measured: on the third day before the treatment and the day before the operation
Chest tube removal time
Record the time from the end of surgery to the removal of chest tube.
Measured: up to 168 hours after surgery
Postoperative pain
VAS ranges from 0 (no pain) to 10 (unbearable pain). A change of 10 for the 100mm pain VAS signify a clinically important improvement or deterioration. Participants will be asked to describe their average surgical incision intensity in the 48 hours after surgery.
Measured: up to 2 days after surgery
Length of postoperative hospital stay
The length of postoperative stay will be recorded.
Measured: up to 14 days after surgery
Intraoperative anesthetic consumption
The types and cumulative doses of intraoperative analgesics will be assessed.
Measured: From the beginning to the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start11 Jan 2023 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acupuncture TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jia Zhou, Study director, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895852
- Sponsor's protocol ID
- 20210427
- Status last verified
- Dec 2022
- First submitted
- 27 Apr 2021
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Reasonable requests for IPD data can be obtained by contacting the investigator.
Publications
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.
PubMed 36797022
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transcutaneous Electrical Acupoints Stimulation for Preoperative Anxiety in Thoracoscopic Surgery: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04895852
- Acronym / sponsor ID
- 20210427
- Keywords
- Acupuncture Treatment, Preoperative Conditioning, Anxiety, Thoracoscopic Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 11 Jan 2023 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single center, randomized, sham-controlled, participant-blinded and assessor-blinded trial will be conducted at the inpatient ward of cardiothoracic surgery department of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine. The trial will commence after ethical approval has been obtained and the protocol has been registered. Patient enrollment started in late June 2021 and is expected to end in March 2023. An estimated 92 participants will be recruited and randomly assigned to receive TEAS or sham TEAS (STEAS) in a l:l ratio using SPSS 21.0 software. During the development of the standard protocol, the Standards for Reporting Interventions in Clinical Trials for Acupuncture (STRICTA) and the SPIRIT reporting guidelines will be followed to explicitly and transparently explain the therapeutic processes involved.
Patients who will undergo VATS for pulmonary nodules will be screened. . Potential subjects will be interviewed preoperatively by the clinical research coordinator to assess whether they meet the inclusion and exclusion criteria. Eligible participants will voluntarily provide written informed consent prior to randomization.
This study will have a single-blind design. The patients are blinded to the group assignment and are told that they might or might not feel a sensation when the TEAS is working. Both acupoint stimulations in the TEAS group and in the STEAS group will be performed by the same acupuncturist who is not involved in the process of data collection. The TEAS instrument is covered with an opaque box for adequate blinding. The randomized numbers were generated with SPSS 21.0 (IBM®SPSS®Statistics, Version 21) software. The random sequence for group classification will be sealed in a confidential envelope. Patients will be randomly allocated into the TEAS group or STEAS group at a ratio of 1:1. Group assignment was exposed from a sealed envelope only by an acupuncturist. Patients will be treated separately to prevent communication. Efficacy evaluation will be conducted blinded to the grouping allocation. The efficacy evaluators and statisticians will be separated and blinded. To test the participant-blinding effects, all participants will be asked to guess whether they had received TEAS or STEAS within 5 minutes after one of the treatment sessions before VATS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS group | Experimental | Device: TEAS30 minutes TEAS therapy on DU20, EX-HN3, LI4, LR3 once per day for three days before surgery. |
| Control group | Sham comparator | Device: Sham TEASThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Those diagnosed as pulmonary nodules requiring VATS.
- Age between 18 and 75 years old.
- 4 ≤ 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEASThe 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). | Device | TEAS group |
| Sham TEASThe 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. | Device | Control group |
Primary outcome
Score change of Generalized Anxiety Scale (GAD-7)
Time frame: up to 3 days before surgery
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.
7 secondary outcomes
5-HT（µmol/L）
Time frame: on the third day before the treatment and the day before the operation
NE（µg/L）
Time frame: on the third day before the treatment and the day before the operation
GABA（µmol/L）
Time frame: on the third day before the treatment and the day before the operation
Chest tube removal time
Time frame: up to 168 hours after surgery
Postoperative pain
Time frame: up to 2 days after surgery
Length of postoperative hospital stay
Time frame: up to 14 days after surgery
Intraoperative anesthetic consumption
Time frame: From the beginning to the end of the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 36797022Wu 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.
- Individual participant dataSharing planned: Yes. Reasonable requests for IPD data can be obtained by contacting the investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Zhou study director
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS in people with Acupuncture Therapy and Preoperative Period, run by Shanghai Yueyang Integrated Medicine Hospital 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 11 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xindi Wu (021-65161782, cindywu1111@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score change of Generalized Anxiety Scale (GAD-7) (time frame: up to 3 days before surgery). 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 NCT04895852, which also lists 1 linked publication.
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 11 Jan 2023.