Clinical trial NCT05757401: Sleep Quality After Cesarean Delivery
Official title: Sleep Quality After Cesarean Delivery Under Spinal Anesthesia With Intrathecal Morphine and Related Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section Complications
Sleep Disturbance
Perioperative Complication
Keywords: cesarean delivery
sleep quality
Perioperative complication
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 286
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients age \>,= 18 years old undergoing cesarean delivery

Brief summary: Surgery causes poor sleep quality for several reasons eg. increasing stress hormonal production, pain, starvation, and environmental procedure namely noise, light, and nursing procedures. Poor sleep quality also brings numerous side effects including delirium, delayed recovery, and affect breastfeeding. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep quality
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Nausea and vomiting score
timeFrame: 24 hours postoperative
measure: Itching
timeFrame: 24 hours postoperative
measure: Postoperative pain
timeFrame: 24 hours postoperative
measure: EQ-5D-5L
timeFrame: 24 hours postoperative
measure: LATCH score
timeFrame: 24 hours postoperative and at the discharge day
measure: Length of hospital stay
timeFrame: Through the study completion an average 3-5 days
measure: Neonatal weight
timeFrame: Postoperative day 1 and day 3
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Anesthesiology department, Siriraj hospital, Mahidol University
Study officials:
affiliation: Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Patchareya Nivatpumin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: