Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery

Thoracoscopic Surgery Clinical Trial

Official title:

Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04124679
• Other study ID #: TAES and sleep
• Status: Completed
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: August 2020
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Sleep Quality
• Thoracoscopic Surgery
• Transcutaneous Electrical Acupoint Stimulation

Intervention

Other:
• Transcutaneous Electrical Acupoint Stimulation
patients received Transcutaneous Electrical Acupoint Stimulation for 30 mins on the acupoints

Locations

Country	Name	City	State
China	Shengjing hospital of China Medical university	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	second night before the surgery
Primary	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..	the first night before surgery
Primary	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.	the first night after the operation
Primary	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.	the third night after the operation
Secondary	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.	one night before the operation and the first and third night after the operation