- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05757401
Sleep Quality After Cesarean Delivery
Sleep Quality After Cesarean Delivery Under Spinal Anesthesia With Intrathecal Morphine and Related Factors
Study Overview
Status
Detailed Description
Surgery causes poor sleep quality for several reasons eg. increasing stress hormonal production, pain, starvation, and environmental procedure namely noise, light, and nursing procedures. Postoperative pain after cesarean delivery can be found as high as 70 percent in the first postoperative pain. Also, the side effect of anesthetic may cause poor sleep quality such as itching, nausea, and vomiting.
Poor sleep quality brings numerous side effects including delirium, delayed recovery, and affect breastfeeding. The data on obstetric patients sleep quality in the early postoperative period is scarce. We, therefore, aim to elucidate the incidence of poor sleep quality in parturients undergoing cesarean delivery in the early postoperative period and investigate the factors involving poor sleep conditions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bangkok, Thailand, 10700
- Anesthesiology department, Siriraj hospital, Mahidol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age >,= 18 years, undergoing cesarean delivery
- Receive spinal anesthesia with local anesthetic drug and intrathecal morphine
- Understand Thai
Exclusion Criteria:
- Patients receive epidural block or nerve block
- Patients require conversion to general anesthesia with any reasons
- Patients require endotracheal intubation with any reasons
- Patients admit to intensive care unit in postoperative period
- Patients with the end of operation at the time 24.00-6.00 AM
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep quality
Time Frame: 24 hours postoperative
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Sleep quality at the first postoperative day evaluated by Richard Campbell Sleep Questionaire- Thai version
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24 hours postoperative
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nausea and vomiting score
Time Frame: 24 hours postoperative
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Nausea and vomiting score; 0 = no symptom, 1= mild symptom nausea and no vomiting, 2 = vomiting 1-2 times, 3 = severe vomiting or needed treatment
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24 hours postoperative
|
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Itching
Time Frame: 24 hours postoperative
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Itching score; 0 = no itching, 1= mild itching, 2 = severe itching or needed treatment
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24 hours postoperative
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Postoperative pain
Time Frame: 24 hours postoperative
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11-point Numerical rating score (NRS) pain scale ranging from 0-10, 0= no pain, 10 = severe pain
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24 hours postoperative
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EQ-5D-5L
Time Frame: 24 hours postoperative
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Quality of life evaluated by EuroQol group-5 Dimentions-5 levels questionnaire (EQ-5D-5L)- Thai version
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24 hours postoperative
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LATCH score
Time Frame: 24 hours postoperative and at the discharge day
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LATCH score comprise of 5 components: Latch, Audible swallowing, Type of nipple, Comfort and Hold- each component scored from 0-2, A total of less than 8 is considered unsatisfactory
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24 hours postoperative and at the discharge day
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Length of hospital stay
Time Frame: Through the study completion an average 3-5 days
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Length of hospital stay
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Through the study completion an average 3-5 days
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Neonatal weight
Time Frame: Postoperative day 1 and day 3
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The weight of neonate
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Postoperative day 1 and day 3
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patchareya Nivatpumin, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 831/2565(IRB1)
- Si 898/2022 (Registry Identifier: Siriraj Institutional Review Board)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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