Sleep Quality After Cesarean Delivery

Sleep Disturbance Clinical Trial

Official title:

Sleep Quality After Cesarean Delivery Under Spinal Anesthesia With Intrathecal Morphine and Related Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05757401
• Other study ID #: 831/2565(IRB1)
• Secondary ID: Si 898/2022
• Status: Completed
• Start date: March 14, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: May 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: May 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Dyssomnias
• Parasomnias
• Perioperative Complication
• Sleep Disturbance

Locations

Country	Name	City	State
Thailand	Anesthesiology department, Siriraj hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

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