Sleep Quality After Cesarean Delivery

Completed

• Conditions: Sleep Disturbance; Cesarean Section Complications; Perioperative Complication

• Registration Number: NCT05757401
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-07
• Study Start: 2023-03-14
• Status Verified: 2024-05
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 286

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality	24 hours postoperative	Sleep quality at the first postoperative day evaluated by Richard Campbell Sleep Questionaire- Thai version

Secondary Outcome Measures

Name	Time	Method
Itching	24 hours postoperative	Itching score; 0 = no itching, 1= mild itching, 2 = severe itching or needed treatment
LATCH score	24 hours postoperative and at the discharge day	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
Nausea and vomiting score	24 hours postoperative	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
EQ-5D-5L	24 hours postoperative	Quality of life evaluated by EuroQol group-5 Dimentions-5 levels questionnaire (EQ-5D-5L)- Thai version
Length of hospital stay	Through the study completion an average 3-5 days	Length of hospital stay
Postoperative pain	24 hours postoperative	11-point Numerical rating score (NRS) pain scale ranging from 0-10, 0= no pain, 10 = severe pain
Neonatal weight	Postoperative day 1 and day 3	The weight of neonate

Trial Locations

Locations (1)

Anesthesiology department, Siriraj hospital, Mahidol University; 🇹🇭 Bangkok, Thailand