Sleep Quality After Cesarean Delivery | NCT05757401

Studies
Sleep Quality After Cesarean Delivery

NCT05757401

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Dec 22, 2025Actual

Enrollment

286Actual

Phase

Not provided

Conditions

Cesarean Section Complications
Sleep Disturbance
Perioperative Complication

Interventions

Not provided

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Si 898/2022	Registry Identifier	Siriraj Institutional Review Board

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2023Actual

Primary Completion Date

May 15, 2024Actual

Completion Date

May 15, 2024Actual

First Submitted Date

Jan 26, 2023

First Submission Date that Met QC Criteria

Mar 3, 2023

First Posted Date

Mar 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2025

Last Update Posted Date

Dec 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

286Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sleep quality	Sleep quality at the first postoperative day evaluated by Richard Campbell Sleep Questionaire- Thai version	24 hours postoperative

Secondary Outcomes

Measure	Description	Time Frame
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
Itching

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Parturients age >,= 18 years old undergoing cesarean delivery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patchareya Nivatpumin, M.D.	Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthesiology department, Siriraj hospital, Mahidol University		Bangkok		10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41229134	Result	Jintadawong T, Nivatpumin P, Swaengrujitham M, Punchuklang W, Lertbunnaphong T. Sleep quality after caesarean delivery: associated factors and effects on quality of life and early breastfeeding. Ann Med. 2025 Dec;57(1):2582917. doi: 10.1080/07853890.2025.2582917. Epub 2025 Nov 12.

ID	Term
D020447	Parasomnias
D007319	Sleep Initiation and Maintenance Disorders

ID	Term
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D001523	Mental Disorders
D020919	Sleep Disorders, Intrinsic