Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery

Sponsor
Shengjing Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04124679
Collaborator
(none)
78
1
2
9.8
8

Study Details

Study Description

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
  • Other: Transcutaneous Electrical Acupoint Stimulation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
78 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 :
Oct 8, 2019
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jul 31, 2020

Arms and Interventions

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

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 were attached the gel electrodes at the sham acupoints

Outcome Measures

Primary Outcome Measures

  1. sleep quality tested by sleep monitor of the second night before the operation [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 [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 [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 [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 Outcome Measures

  1. subjective sleep quality: Athens Insomnia Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shengjing hospital of China Medical university Shenyang Liaoning China 110004

Sponsors and Collaborators

  • Shengjing Hospital

Investigators

  • Study Director: Junchao h Zhu, Shengjing Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanchao Yang, Principal investigator, Shengjing Hospital
ClinicalTrials.gov Identifier:
NCT04124679
Other Study ID Numbers:
  • TAES and sleep
First Posted:
Oct 11, 2019
Last Update Posted:
Aug 27, 2020
Last Verified:
Aug 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 27, 2020