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OpenTrials
Completed

NCT Number: NCT05757401

Sleep Quality After Cesarean Delivery

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.

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Key information

Conditions

Cesarean Section Complications Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Perioperative Complication Sleep Disorders, Intrinsic Sleep Disturbance Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sleep quality

    Time frame: 24 hours postoperative

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

Secondary outcomes

  1. Nausea and vomiting score

    Time frame: 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

  2. Itching

    Time frame: 24 hours postoperative

    Itching score; 0 = no itching, 1= mild itching, 2 = severe itching or needed treatment

  3. Postoperative pain

    Time frame: 24 hours postoperative

    11-point Numerical rating score (NRS) pain scale ranging from 0-10, 0= no pain, 10 = severe pain

  4. EQ-5D-5L

    Time frame: 24 hours postoperative

    Quality of life evaluated by EuroQol group-5 Dimentions-5 levels questionnaire (EQ-5D-5L)- Thai version

  5. LATCH score

    Time frame: 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

  6. Length of hospital stay

    Time frame: Through the study completion an average 3-5 days

    Length of hospital stay

  7. Neonatal weight

    Time frame: Postoperative day 1 and day 3

    The weight of neonate

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2023
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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