Transcutaneous Electrical Acupoint StimulationNCT04124679
Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery
A study testing Transcutaneous Electrical Acupoint Stimulation in people with Transcutaneous Electrical Acupoint Stimulation and Thoracoscopic Surgery, run by Shengjing Hospital at 1 site in China.
Trial summary
General anesthesia is a medically induced state of low reactivity consciousness which is similar to natural sleep.Some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transcutaneous Electrical Acupoint Stimulation, Thoracoscopic Surgery, Postoperative Sleep Quality
- What is being tested?
- Transcutaneous Electrical Acupoint Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2019to 31 Jul 2020
- 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
- ASA ( American Society of Anesthesiologists):I-II
- age for 18-75 years
Who cannot join
- History of central nervous system and mental illness
- use of sedatives or antidepressants
- infection or wound at the percutaneous acupuncture point
- unwilling to participate
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing hospital of China Medical university
Shenyang, Liaoning, 110004
About this study
General anesthesia is a medically induced state of low reactivity consciousness which is similar to natural sleep.Some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow wave sleep (SWS),which have significant deleterious impacts on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even pain sensitivity or postoperative pain of patients.Acupuncture can regulate plant nerve activity by increasing slow-wave sleep time to improve sleep quality.The results of polysomnography monitoring showed that the sleep latency, total sleep time, awakening index and sleep quality were all significant improved after acupuncture treatment.And transcutaneous electrical acupoint stimulation（TAES） works by stimulating Shu yu acupoints, which is more convenient than the normal electric acupuncture. The purpose of this paper is to study the effect of TAES on sleep after thoracoscopic surgery
Read the detailed description
In TEAS group, an experienced acupuncturist performed 30 minutes of TEAS treatment at the HT7 (Shenmen) and Neiguan (PC6) acupoints on bilateral side, which were identified in accordance with the TCM anatomic localizations on the first night before surgery by a stimulator (Hwato Electronic Acupuncture Treatment Instrument, model no.: SDZ-II; Suzhou Medical Appliances Co. Ltd, Suzhou, China). And after surgery, ST36 (Zusanli) and LI4 (Hegu) acupoints were added for the effect of relieving postoperative complications. 30 minutes of TEAS treatment was also performed on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints on the first three nights after surgery. The TEAS was standardized before each treatment and was set at 2/10 HZ, which has been documented as the most effective frequency. The optimal intensity is from 6 to 15mA, which was adjusted according to individual maximum tolerance to maintain a slight twitching of the regional muscles. Patients in the control group were attached the gel electrodes at the sham acupoints. The acupuncture points were to be stimulated by microcurrents generated by a special electrical device, which the patients may only experience a mild electric current sensation or nothing at all.
- Conditions
- Transcutaneous Electrical Acupoint Stimulation, Thoracoscopic Surgery, Postoperative Sleep Quality
- Being tested
- Transcutaneous Electrical Acupoint Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Acupoint StimulationOther
patients received Transcutaneous Electrical Acupoint Stimulation for 30 mins on the acupoints
| Study group | Role | What they receive |
|---|---|---|
| TAES group | Experimental | In TEAS group, an experienced acupuncturist performed 30 minutes of TEAS treatment at the HT7 (Shenmen) and Neiguan (PC6) acupoints on bilateral side, which were identified in accordance with the TCM anatomic localizations on the first night before surgery by a stimulator (Hwato Electronic Acupuncture Treatment Instrument, model no.: SDZ-II; Suzhou Medical Appliances Co. Ltd, Suzhou, China). And after surgery, ST36 (Zusanli) and LI4 (Hegu) acupoints were added for the effect of relieving postoperative complications. 30 minutes of TEAS treatment was also performed on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints on the first three nights after surgery Receives: Other: Transcutaneous Electrical Acupoint Stimulation |
| Control group | No intervention | Patients in the control group were attached the gel electrodes at the sham acupoints |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality tested by sleep monitor of the second night before the operation
using sleep monitor to test the sleep quality on second night before the operation, analyze sleep quality according to each percentage of sleep stage.
Measured: second night before the surgery
sleep quality tested by sleep monitor of the first night before the operation
using sleep monitor to test the sleep quality on first night before the operation, analyze sleep quality according to each percentage of sleep stage..
Measured: the first night before surgery
sleep quality tested by sleep monitor of the first night after the operation
using sleep monitor to test the sleep quality on the first night after the operation,analyze sleep quality according to each percentage of sleep stage.
Measured: the first night after the operation
sleep quality of the tested by sleep monitor on the third night after the operation
using sleep monitor to test the sleep quality on the third night after the operation,analyze sleep quality according to each percentage of sleep stage.
Measured: the third night after the operation
Secondary outcomes (1)
subjective sleep quality: Athens Insomnia Scale
using the Athens Insomnia Scale to test the subjective sleep quality of patients. The range were from 0-3. Total score < 4 means sleep well; total score =6 means suspicious of insomnia; total score > 6 means insomnia.
Measured: one night before the operation and the first and third night after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start8 Oct 2019
- Primary completion30 Jun 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Electrical Acupoint StimulationStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
- Investigators
- Junchao h Zhu, Study director, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124679
- Sponsor's protocol ID
- TAES and sleep
- Status last verified
- Aug 2020
- First submitted
- 8 Oct 2019
- Last updated
- 27 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT04124679
- Acronym / sponsor ID
- TAES and sleep
- Conditions
- Transcutaneous Electrical Acupoint Stimulation, Thoracoscopic Surgery, Postoperative Sleep Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 11 Oct 2019 (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.
General anesthesia is a medically induced state of low reactivity consciousness which is similar to natural sleep.Some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow wave sleep (SWS),which have significant deleterious impacts on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even pain sensitivity or postoperative pain of patients.Acupuncture can regulate plant nerve activity by increasing slow-wave sleep time to improve sleep quality.The results of polysomnography monitoring showed that the sleep latency, total sleep time, awakening index and sleep quality were all significant improved after acupuncture treatment.And transcutaneous electrical acupoint stimulation（TAES） works by stimulating Shu yu acupoints, which is more convenient than the normal electric acupuncture. The purpose of this paper is to study the effect of TAES on sleep after thoracoscopic surgery
Detailed description
In TEAS group, an experienced acupuncturist performed 30 minutes of TEAS treatment at the HT7 (Shenmen) and Neiguan (PC6) acupoints on bilateral side, which were identified in accordance with the TCM anatomic localizations on the first night before surgery by a stimulator (Hwato Electronic Acupuncture Treatment Instrument, model no.: SDZ-II; Suzhou Medical Appliances Co. Ltd, Suzhou, China). And after surgery, ST36 (Zusanli) and LI4 (Hegu) acupoints were added for the effect of relieving postoperative complications. 30 minutes of TEAS treatment was also performed on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints on the first three nights after surgery. The TEAS was standardized before each treatment and was set at 2/10 HZ, which has been documented as the most effective frequency. The optimal intensity is from 6 to 15mA, which was adjusted according to individual maximum tolerance to maintain a slight twitching of the regional muscles. Patients in the control group were attached the gel electrodes at the sham acupoints. The acupuncture points were to be stimulated by microcurrents generated by a special electrical device, which the patients may only experience a mild electric current sensation or nothing at all.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAES group | Experimental | Other: Transcutaneous Electrical Acupoint StimulationIn TEAS group, an experienced acupuncturist performed 30 minutes of TEAS treatment at the HT7 (Shenmen) and Neiguan (PC6) acupoints on bilateral side, which were identified in accordance with the TCM anatomic localizations on the first night before surgery by a stimulator (Hwato Electronic Acupuncture Treatment Instrument, model no.: SDZ-II; Suzhou Medical Appliances Co. Ltd, Suzhou, China). And after surgery, ST36 (Zusanli) and LI4 (Hegu) acupoints were added for the effect of relieving postoperative complications. 30 minutes of TEAS treatment was also performed on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints on the first three nights after surgery |
| Control group | No intervention | –Patients in the control group were attached the gel electrodes at the sham acupoints |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA ( American Society of Anesthesiologists):I-II
- age for 18-75 years
Key exclusion criteria (4 listed)
- History of central nervous system and mental illness
- use of sedatives or antidepressants
- infection or wound at the percutaneous acupuncture point
- unwilling to participate
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 |
|---|---|---|
| Transcutaneous Electrical Acupoint Stimulationpatients received Transcutaneous Electrical Acupoint Stimulation for 30 mins on the acupoints | Other | TAES group |
Primary outcome
sleep quality tested by sleep monitor of the second night before the operation
Time frame: second night before the surgery
using sleep monitor to test the sleep quality on second night before the operation, analyze sleep quality according to each percentage of sleep stage.
sleep quality tested by sleep monitor of the first night before the operation
Time frame: the first night before surgery
using sleep monitor to test the sleep quality on first night before the operation, analyze sleep quality according to each percentage of sleep stage..
sleep quality tested by sleep monitor of the first night after the operation
Time frame: the first night after the operation
using sleep monitor to test the sleep quality on the first night after the operation,analyze sleep quality according to each percentage of sleep stage.
sleep quality of the tested by sleep monitor on the third night after the operation
Time frame: the third night after the operation
using sleep monitor to test the sleep quality on the third night after the operation,analyze sleep quality according to each percentage of sleep stage.
1 secondary outcome
subjective sleep quality: Athens Insomnia Scale
Time frame: one night before the operation and the first and third night after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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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.
Junchao h Zhu study director
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Acupoint Stimulation in people with Transcutaneous Electrical Acupoint Stimulation and Thoracoscopic Surgery, run by Shengjing 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 27 Aug 2020. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality tested by sleep monitor of the second night before the operation (time frame: second night before the surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2020.