Actively Recruiting

Age: 20Years - 45Years
FEMALE
ID05446636

Circadian Rhythm Status and Cesarean Section Postoperative Pain Study

Led by The Second Affiliated Hospital of Chongqing Medical University · Updated on 2024-08-15

280

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the relationship between maternal circadian rhythm and postoperative pain after cesarean section under combined spinal-epidural anesthesia. The study focuses on women aged 20 to 45 years who are undergoing elective cesarean section. The goal is to explore how maternal biological rhythms may affect pain levels following surgery. Participants will wear a Huawei wristwatch device that continuously monitors respiration, heart rate, temperature, and sleep patterns. This device helps calculate the maternal circadian rhythm status during the study. The observation period includes the time from inclusion until the patient's discharge, with assessments up to one week post-surgery. During the study, researchers will record pain intensity using the Visual Analog Scale (VAS) at intervals from the end of surgery up to 24 hours afterward. They will monitor heart rate variability, body temperature variability, physical activity, and sleep phases such as deep sleep and rapid eye movement sleep. These data aim to identify correlations between circadian rhythm and pain after cesarean section. Participants will be closely followed until discharge and assessed for safety and well-being throughout the study period.

CONDITIONS

Brief Title

Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain

Who Can Participate

Age: 20Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 to 45 years
  • ASA (American Society of Anesthesiologists) status II-III
  • Gestational age between 37 and 42 weeks
  • Scheduled for elective cesarean section with subarachnoid anesthesia
  • Willing to participate and sign informed consent
Not Eligible

You will not qualify if you...

  • Contraindications to combined spinal and epidural anesthesia
  • Severe systemic disease
  • Alcoholism or long-term use of anti-inflammatory and analgesic drugs
  • Unable to cooperate or refusal to participate
  • Psychiatric disorder
  • Considered unsuitable or unable to cooperate by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - From inclusion until postoperative discharge, assessed up to 1 week

Participants wear a Huawei bracelet to continuously record maternal respiration, heart rate, temperature, and sleep data to assess circadian rhythm status from inclusion until postoperative discharge.

Continuous monitoring with the device during hospitalization

Surgery and Immediate Post-operative Care

Duration - 24 hours after cesarean section

Participants undergo elective cesarean section with subarachnoid anesthesia and are monitored for pain intensity and physiological data from the end of surgery up to 24 hours.

Monitoring during hospital stay and assessments at 0-6, 6-12, and 12-24 hours post-surgery

Trial Site Locations

Total: 1 location

1

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

Chongqing, Chongqing Municipality, China, 400010

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Research Team

H

HUANG HE, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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