Sleep Quality After Cesarean Delivery

Sponsor
Mahidol University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05757401
Collaborator
(none)
286
1
25
11.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    286 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Sleep Quality After Cesarean Delivery Under Spinal Anesthesia With Intrathecal Morphine and Related Factors
    Anticipated Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    Feb 28, 2025
    Anticipated Study Completion Date :
    Mar 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Sleep quality [24 hours postoperative]

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

    Secondary Outcome Measures

    1. 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

    2. Itching [24 hours postoperative]

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

    3. Postoperative pain [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 [24 hours postoperative]

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

    5. 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

    6. Length of hospital stay [Through the study completion an average 3-5 days]

      Length of hospital stay

    7. Neonatal weight [Postoperative day 1 and day 3]

      The weight of neonate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anesthesiology department, Siriraj hospital, Mahidol University Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Patchareya Nivatpumin, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT05757401
    Other Study ID Numbers:
    • 831/2565(IRB1)
    • Si 898/2022
    First Posted:
    Mar 7, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mahidol University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 7, 2023