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Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery

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ClinicalTrials.gov Identifier: NCT04124679
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Yanchao Yang, Shengjing Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Transcutaneous Electrical Acupoint Stimulation Thoracoscopic Surgery Postoperative Sleep Quality Other: Transcutaneous Electrical Acupoint Stimulation Not Applicable

Detailed Description:
Patients scheduled for thoracoscopic surgery under general anesthesia were enrolled. Patients were randomized to transcutaneous electrical acupoint stimulation group (TAES group) and control group (C group). Patients in the TAES group received continuous transcutaneous electrical acupoint stimulation for 30min before sleep on one night before the operation, 30min before start of the operation and 30min before sleep for the first, third and fifth night after the operation. The portable sleep monitor (PSM) was performed on one night before the operation and the first, third and fifth night after the operation. The subjective sleep quality using the Athens Insomnia Scale on one night before the operation and the first, third and fifth night after the operation. The subjective sleep quality using the Athens Insomnia Scale were also recorded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: TAES group
Patients in the TAES group received continuous transcutaneous electrical acupoint stimulation for 30min before sleep on one night before the operation, 30min before start of the operation and 30min before sleep for the first, third and fifth night after the operation.
Other: Transcutaneous Electrical Acupoint Stimulation
patients received Transcutaneous Electrical Acupoint Stimulation for 30 mins on the acupoints

No Intervention: Control group
patients in the control group would not receive any intervention.



Primary Outcome Measures :
  1. sleep quality tested by sleep monitor of one night before the operation [ Time Frame: one night before the surgery ]
    using sleep monitor to test the sleep quality on one 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 after the operation [ Time Frame: the first night after surgery ]
    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.

  3. sleep quality tested by sleep monitor of 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.

  4. sleep quality of the tested by sleep monitor fifth night after the operation [ Time Frame: the fifth night after the operation ]
    using sleep monitor to test the sleep quality on the fifth night after the operation,analyze sleep quality according to each percentage of sleep stage.


Secondary Outcome Measures :
  1. subjective sleep quality: Athens Insomnia Scale [ Time Frame: one night before the operation and the first, third and fifth 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA ( American Society of Anesthesiologists):I-II
  • age for 18-65 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04124679


Contacts
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Contact: Junchao h Zhu 18940257257 ext 18940257257 zhujc@sj-hospital.org
Contact: bijia Song 18309845273 ext 18309845273 630992254@qq.com

Locations
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China, Liaoning
Shengjing hospital of China Medical university Recruiting
Shenyang, Liaoning, China, 110004
Contact: bijia Song    18309845273 ext 18309845273    630992254@qq.com   
Sponsors and Collaborators
Shengjing Hospital
Investigators
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Study Director: Junchao h Zhu Shengjing Hospital

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Responsible Party: Yanchao Yang, Principal investigator, Shengjing Hospital
ClinicalTrials.gov Identifier: NCT04124679     History of Changes
Other Study ID Numbers: TAES and sleep
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No