- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04124679
Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery
August 24, 2020 updated by: Yanchao Yang, Shengjing Hospital
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
78
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 Locations
-
-
Liaoning
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Shenyang, Liaoning, China, 110004
- Shengjing Hospital of China Medical University
-
-
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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA ( American Society of Anesthesiologists):I-II
- age for 18-75 years
Exclusion Criteria:
- History of central nervous system and mental illness
- use of sedatives or antidepressants
- infection or wound at the percutaneous acupuncture point
- unwilling to participate
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TAES group
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
|
patients received Transcutaneous Electrical Acupoint Stimulation for 30 mins on the acupoints
|
No Intervention: Control group
Patients in the control group were attached the gel electrodes at the sham acupoints
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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second night before the surgery
|
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..
|
the first night before surgery
|
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.
|
the first night after the operation
|
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.
|
the third night after the operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
subjective sleep quality: Athens Insomnia Scale
Time Frame: one night before the operation and the first and third night after the operation
|
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.
|
one night before the operation and the first and third night after the operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Junchao h Zhu, Shengjing Hospital
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 (Actual)
October 8, 2019
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
July 31, 2020
Study Registration Dates
First Submitted
October 8, 2019
First Submitted That Met QC Criteria
October 10, 2019
First Posted (Actual)
October 11, 2019
Study Record Updates
Last Update Posted (Actual)
August 27, 2020
Last Update Submitted That Met QC Criteria
August 24, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- TAES and sleep
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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