Circadian RhythmNCT05446636
Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain
An observational study of Circadian Rhythm, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Circadian Rhythm
- What is being tested?
- Huawei bracelet
- Type of treatment
- Medical device
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2023to Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: pregnant women
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, The Second Affiliated Hospital, Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Guangyou Duan, M.D., (+86)13708385559, duangy@hospital.cqmu.edu.cn
About this study
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
- Being tested
- Huawei bracelet
- Keywords
- Circadian Rhythm, Cesarean Section, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huawei braceletDevice
Huawei bracelet was used to continuously record maternal respiration, heart rate, temperature and sleep data, and then calculate maternal circadian rhythm state
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of moderate and severe pain after cesarean section
number rating scale (NRS) for pain (0=no pain to 10=worst pain) >4
Measured: From ending of the surgery to 24hours after cesarean section
Secondary outcomes (8)
Pain intensity durig 0 to 6 hours after surgery
number rating scale (NRS) for pain (0=no pain to 10=worst pain)
Measured: From ending of the surgery to 6 hours after cesarean section
Pain intensity durig 6 to 12 hours after surgery
number rating scale (NRS) for pain (0=no pain to 10=worst pain)
Measured: From 6 hours after cesarean section to 12 hours after cesarean section
Pain intensity durig 12 to 24 hours after surgery
number rating scale (NRS) for pain (0=no pain to 10=worst pain)
Measured: From 12 hours after cesarean section to 24 hours after cesarean section
Heart rate variability
Heart rate variability recorded by Huawei bracelet
Measured: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Body temperature variability
Body temperature variability recorded by Huawei bracelet
Measured: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Variability of patients' activity
Variability of patients' activity recorded by Huawei bracelet
Measured: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Percentage of deep sleep
Percentage of deep sleep evaluated by Huawei bracelet
Measured: 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
Percentage of rapid eye movement sleep evaluated by Huawei bracelet
Measured: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start14 Feb 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guangyou Duan, MD, Study director, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446636
- Sponsor's protocol ID
- Biological rhythm and CS pain
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Rhythm Status and CS (Cesarean Section) Postoperative Pain
- ClinicalTrials.gov ID
- NCT05446636
- Acronym / sponsor ID
- Biological rhythm and CS pain
- Conditions
- Circadian Rhythm
- Keywords
- Circadian Rhythm, Cesarean Section, Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huawei braceletHuawei bracelet was used to continuously record maternal respiration, heart rate, temperature and sleep data, and then calculate maternal circadian rhythm state | Device | – |
Primary outcome
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
8 secondary outcomes
Pain intensity durig 0 to 6 hours after surgery
Time frame: 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
Pain intensity durig 12 to 24 hours after surgery
Time frame: 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
Body temperature variability
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
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
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
Time frame: From the time of inclusion in the study until the patient's postoperative discharge, assessed up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guangyou Duan, MD study director
The Second Affiliated Hospital, Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circadian Rhythm, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HUANG HE, MD ((+86)13708385559, huanghe@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of moderate and severe pain after cesarean section (time frame: From ending of the surgery to 24hours after cesarean section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.