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Completed

NCT Number: NCT04124679

Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery

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

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Key information

Conditions

Transcutaneous Electrical Acupoint Stimulation Postoperative Sleep Quality Thoracoscopic Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shengjing hospital of China Medical university

Shenyang, Liaoning, 110004, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcutaneous electrical acupoint stimulation

Other

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

Primary outcomes

  1. 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.

  2. 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..

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 11, 2019
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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