Effect of Transcutaneous Electrical Acupoint Stimulation on Sleep After Thoracoscopic Surgery

NCT04124679 | Completed

• 1 other identifier: TAES and sleep
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Transcutaneous Electrical Acupoint Stimulation; Thoracoscopic Surgery; Postoperative Sleep Quality

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (1)

• subjective sleep quality: Athens Insomnia Scale

  one night before the operation and the first and third night after the operation

Study Arms (2)

TAES group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Patients in the control group were attached the gel electrodes at the sham acupoints

Interventions

Transcutaneous Electrical Acupoint Stimulation OTHER

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

TAES group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing hospital of China Medical university

Shenyang, Liaoning, 110004, China

Location

Study Officials

• Junchao h Zhu

  Shengjing Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 11, 2019
• Study Start: October 8, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 31, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

CN (1)