Acupoint Stimulation and Postoperative Sleep (ASIS)

April 15, 2024 updated by: Zhihong LU, Air Force Military Medical University, China

Effect of Transcutaneous Electrical Acupoint Stimulation on Sleeping After General Anesthesia in Gynecological Laparoscopic Surgery

Sleeping model can be affected after surgery. Anesthetics may be involved in the change. The changing of sleeping mode may exert adverse effect on postoperative recovery. Acupuncture and related techniques has been used for treating sleeping disorder. In this study, the effect of transcutaneous electrical acupoint stimulation on sleeping model after general anesthesia will be observed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Sleep is a necessary, naturally occurring physiologic state that is especially critical to cognition and physical functioning in surgical settings.Poor postoperative sleep is associated with many significant deleterious effects. Therefore, improving overall sleep during postoperative rehabilitation is desirable.

Transcutaneous electrical acupoint stimulation (TEAS) is a non-invasive acupuncture therapy combining the transcutaneous electrical nerve stimulation, and has been utilized in clinical settings for many years. Previous study demonstrated that TEAS combined with anesthesia can upregulate the levels of melatonin and aminobutyric acid to relief central inhibition, thus improve patients'sleep efficiency, prolong total sleep time (TST) and promote sleep quality.

The current study is to examine the effect of perioperative TEAS on subjective and objective sleep quality among patients who have undergone Gynecological laparoscopic surgery under general anesthesia.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
274

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Northwest Women's and Children's Hospital
      • Xi'an, Shaanxi, China
        • the First Affiliated Hospital of the Air Force Military Medical University
      • Xi'an, Shaanxi, China
        • The Second Affiliated Hospital of Xi 'an Jiaotong University
      • Xi'an, Shaanxi, China
        • Xi 'an Hospital of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Patients scheduled for elective Gynecological laparoscopic surgery under general anesthesia
  2. Patients aged 18-65 years
  3. Patients with a body mass index (BMI) at 18-30kg/m2
  4. Patients with American Society of Anesthesiologists (ASA) grades I-III
  5. Patients who provide written informed consent

Exclusion Criteria

  1. Participants with sleep apnea or moderate and severe obstructive sleep apnea syndrome (defined by Apnea Hypopnea Index (AHI))
  2. Participants with preoperative sleep disturbances (diagnostic criteria of sleep disturbances according to the International Classification of Sleep Disorders, Third Edition (ICSD-3));
  3. Participants with central nervous system and mental disease, or difficult to communicate, or unable to cooperate with the investigators.
  4. Participants with contraindications to the use of electroacupuncture (including those with infection or injury of the skin to attach electrodes, and those with implanted electronic devices).
  5. Participants who had severe diseases of the cardiovascular or hematopoietic systems, or had severe hepatic or renal insufficiency kidney disease
  6. Participants with a history of alcohol or drug abuse. Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: transcutaneous electrical acupoint stimulation
transcutaneous electrical acupoint stimulation is one of the many forms of acupuncture, and is a distinctive part of Chinese medicine that has been practiced in China for thousands of years. It is employed by placing electrodes on acupoint and electrical stimulation is given after anesthetic induction to the end of the surgery.
Other: transcutaneous electrical acupoint stimulation
Electrodes will be attached on the surface of acupoints and electrical stimulation will given.
Other Names:
  • TEAS
No Intervention: Control
Electrodes are placed on same acupoints as the experimental group, and will receive the "optimal intensity test" before the anesthesia induction, but no electrical stimulation is given during the operation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
total sleeping time during the first postoperative night
Time Frame: the first postoperative night
The primary outcome is the total sleep time on the first postoperative night according to the sleep diary monitored by actigraphy.
the first postoperative night

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total sleep time during the first 24h after surgery
Time Frame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
total sleep time recorded on the actigraphy on the first perioperative night
from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
the Pittsburgh Sleep Quality Index (PSQI) questionnaire for the last month before surgery
Time Frame: the 1 month before hospitalization
The PSQI is used to indicate the sleep quality in the last 1 month.
the 1 month before hospitalization
The Athens Insomnia Scale (AIS) score
Time Frame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
The highest score on the Athens Scale is 24, while the lowest score is 0. The higher the score, the more serious the sleep disorder
from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
the Epworth Sleepiness Scale (ESS) score
Time Frame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
ESS scores range from 0 to 24, with higher scores indicating higher levels of sleepiness
from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
the 15-item Quality of Recovery Scale (QoR-15) score
Time Frame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
The QoR-15 score ranges from 0 to 150, and the higher the score, the better the postoperative recovery
from discharge from post-anesthesia care unit to 24hours later, totally 24 hours
Total intraoperative propofol dosage
Time Frame: From the time of anesthetic induction to the end of the surgery
the total dosage used for the anesthetic induction and maintenance
From the time of anesthetic induction to the end of the surgery
Times for the needs of rescue analgesics
Time Frame: from discharge from operation room to 24 hours later, totally 24 hours
Times for the needs of rescue analgesics in the first 24h.
from discharge from operation room to 24 hours later, totally 24 hours
Number of episodes of postoperative adverse events
Time Frame: from discharge from the operation room to 48 hours later, totally 48 hours
Number of episodes of postoperative adverse events such as nausea and vomiting, delirium, pulmonary edema, septic shock, arrhythmia, etc after surgery.
from discharge from the operation room to 48 hours later, totally 48 hours
time of intestinal recovery after surgery
Time Frame: from discharge from the operation room to 48 hours later, totally 48 hours
time to first flatus, time to food intake, catheter remove and ambulation
from discharge from the operation room to 48 hours later, totally 48 hours
length of postoperative hospital stay
Time Frame: from date of randamization until the time of discharge from the hospital from any cause,assessed up to 5 days
length of postoperative hospital stay
from date of randamization until the time of discharge from the hospital from any cause,assessed up to 5 days
total wake time during the first 24h after surgery
Time Frame: from discharge from post-anesthesia care unit to 24hours later, totally 24 hours]
recorded on the actigraphy on the first perioperative night
from discharge from post-anesthesia care unit to 24hours later, totally 24 hours]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XJH-A-20220325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual data including protocol and statistical analysis plan will be shared during 3 months and 5 years following article publication after deidentification.

IPD Sharing Time Frame

during 3 months and 5 years following article publication after deidentification

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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