Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain

NCT05446636 | Recruiting

• 1 other identifier: Biological rhythm and CS pain
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Circadian Rhythm

Keywords

Circadian Rhythm; Cesarean Section; Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of moderate and severe pain 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 Outcomes (8)

• Pain intensity durig 0 to 6 hours after surgery

  From ending of the surgery to 6 hours after cesarean section

• Pain intensity durig 6 to 12 hours after surgery

  From 6 hours after cesarean section to 12 hours after cesarean section

• Pain intensity durig 12 to 24 hours after surgery

  From 12 hours after cesarean section to 24 hours after cesarean section

• Heart rate variability

  From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week

• Body temperature variability

  From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week

Interventions

Huawei bracelet DEVICE

Huawei bracelet was used to continuously record maternal respiration, heart rate, temperature and sleep data, and then calculate maternal circadian rhythm state

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guangyou Duan, MD

  The Second Affiliated Hospital, Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

HUANG HE, MD

CONTACT

(+86)13708385559; huanghe@cqmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: July 7, 2022
• Study Start: February 14, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within five years

Locations

CN (1)