NCT05757401

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1.2 years

First QC Date

January 26, 2023

Last Update Submit

December 16, 2025

Conditions

Cesarean Section ComplicationsSleep DisturbancePerioperative Complication

Keywords

cesarean deliverysleep qualityPerioperative complication

Outcome Measures

Primary Outcomes (1)

  • Sleep quality

    Sleep quality at the first postoperative day evaluated by Richard Campbell Sleep Questionaire- Thai version

    24 hours postoperative

Secondary Outcomes (7)

  • Nausea and vomiting score

    24 hours postoperative

  • Itching

    24 hours postoperative

  • Postoperative pain

    24 hours postoperative

  • EQ-5D-5L

    24 hours postoperative

  • LATCH score

    24 hours postoperative and at the discharge day

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parturients age \>,= 18 years old undergoing cesarean delivery

You may qualify if:

  • Age \>,= 18 years, undergoing cesarean delivery
  • Receive spinal anesthesia with local anesthetic drug and intrathecal morphine
  • Understand Thai

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 41229134RESULT

MeSH Terms

Conditions

ParasomniasSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersSleep Disorders, IntrinsicDyssomnias

Study Officials

  • Patchareya Nivatpumin, M.D.

    Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2023

First Posted

March 7, 2023

Study Start

March 14, 2023

Primary Completion

May 15, 2024

Study Completion

May 15, 2024

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

TH(1)