Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain

August 13, 2024 updated by: The Second Affiliated Hospital of Chongqing Medical University
Use huawei wristwatch to record maternal rhythm status and record the VAS score after cesarean section under combined spinal-epidural anesthesia. Based on this study the investigators intend to explore the correlation between maternal circadian rhythm status and postoperative pain after cesarean section.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

280

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 Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400010
        • Recruiting
        • Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
        • Contact:

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

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

pregnant women

Description

Inclusion Criteria:

  • Age 20 to 45
  • ASA(American society of anesthesiologists) status II-III
  • 37-42 weeks gestation
  • undergo elective cesarean section with subarachnoid anesthesia
  • participate in this study and sign informed consent

Exclusion Criteria:

  • Patients with contraindications of combined spinal and epidural anesthesia
  • Patients with severe systemic disease
  • Alcoholism and long-term use of anti-inflammatory and analgesic drugs
  • Patients who were unable to cooperate or refused to participate in the trial
  • with psychiatric disorder
  • researchers considered unsuitable to participate in or unable to cooperate with the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of moderate and severe pain after cesarean section
Time Frame: From ending of the surgery to 24hours after cesarean section
number rating scale (NRS) for pain (0=no pain to 10=worst pain) >4
From ending of the surgery to 24hours after cesarean section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity durig 0 to 6 hours after surgery
Time Frame: From ending of the surgery to 6 hours after cesarean section
number rating scale (NRS) for pain (0=no pain to 10=worst pain)
From ending of the surgery to 6 hours after cesarean section
Pain intensity durig 6 to 12 hours after surgery
Time Frame: From 6 hours after cesarean section to 12 hours after cesarean section
number rating scale (NRS) for pain (0=no pain to 10=worst pain)
From 6 hours after cesarean section to 12 hours after cesarean section
Pain intensity durig 12 to 24 hours after surgery
Time Frame: From 12 hours after cesarean section to 24 hours after cesarean section
number rating scale (NRS) for pain (0=no pain to 10=worst pain)
From 12 hours after cesarean section to 24 hours after cesarean section
Heart rate variability
Time Frame: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Heart rate variability recorded by Huawei bracelet
From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Body temperature variability
Time Frame: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Body temperature variability recorded by Huawei bracelet
From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Variability of patients' activity
Time Frame: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Variability of patients' activity recorded by Huawei bracelet
From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Percentage of deep sleep
Time Frame: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Percentage of deep sleep evaluated by Huawei bracelet
From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Percentage of rapid eye movement sleep
Time Frame: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Percentage of rapid eye movement sleep evaluated by Huawei bracelet
From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week

Collaborators and Investigators

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

Sponsor

The Second Affiliated Hospital of Chongqing Medical University

Investigators

  • Study Director: Guangyou Duan, MD, The Second Affiliated Hospital, Chongqing Medical University

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)

February 14, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 1, 2022

First Submitted That Met QC Criteria

July 3, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biological rhythm and CS pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Within five years

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • 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

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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