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临床试验/NCT04124679
NCT04124679已完成不适用

Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery

Shengjing Hospital1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2019年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
sleep quality tested by sleep monitor of the first night before the operation

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA ( American Society of Anesthesiologists):I-II
  • age for 18-75 years

排除标准

  • History of central nervous system and mental illness
  • use of sedatives or antidepressants
  • infection or wound at the percutaneous acupuncture point
  • unwilling to participate

结局指标

主要结局

sleep quality tested by sleep monitor of the first night before the operation

时间窗: 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

时间窗: 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 tested by sleep monitor of the second night before the operation

时间窗: 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 of the tested by sleep monitor on the third night after the operation

时间窗: 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.

次要结局

  • subjective sleep quality: Athens Insomnia Scale(one night before the operation and the first and third night after the operation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanchao Yang

Principal investigator

Shengjing Hospital

研究点 (1)

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