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Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain

Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05446636
Enrollment
280
Registered
2022-07-07
Start date
2023-02-14
Completion date
2025-06-30
Last updated
2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Rhythm

Keywords

Circadian Rhythm, Cesarean Section, Pain

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.

Interventions

DEVICEHuawei bracelet

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

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of moderate and severe pain after cesarean sectionFrom ending of the surgery to 24hours after cesarean sectionnumber rating scale (NRS) for pain (0=no pain to 10=worst pain) \>4

Secondary

MeasureTime frameDescription
Pain intensity durig 12 to 24 hours after surgeryFrom 12 hours after cesarean section to 24 hours after cesarean sectionnumber rating scale (NRS) for pain (0=no pain to 10=worst pain)
Pain intensity durig 0 to 6 hours after surgeryFrom ending of the surgery to 6 hours after cesarean sectionnumber rating scale (NRS) for pain (0=no pain to 10=worst pain)
Heart rate variabilityFrom the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 weekHeart rate variability recorded by Huawei bracelet
Pain intensity durig 6 to 12 hours after surgeryFrom 6 hours after cesarean section to 12 hours after cesarean sectionnumber rating scale (NRS) for pain (0=no pain to 10=worst pain)
Variability of patients' activityFrom the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 weekVariability of patients' activity recorded by Huawei bracelet
Percentage of deep sleepFrom the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 weekPercentage of deep sleep evaluated by Huawei bracelet
Percentage of rapid eye movement sleepFrom the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 weekPercentage of rapid eye movement sleep evaluated by Huawei bracelet
Body temperature variabilityFrom the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 weekBody temperature variability recorded by Huawei bracelet

Countries

China

Contacts

Primary ContactHUANG HE, MD
huanghe@cqmu.edu.cn(+86)13708385559

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026