Effect of Preoperative Anxiety on Fetus in Pregnant Women

Sponsor
Bozok University (Other)
Overall Status
Completed
CT.gov ID
NCT04226573
Collaborator
(none)
30
1
5.4
5.5

Study Details

Study Description

Brief Summary

In the preoperative period, 60-80% of the patients had anxiety symptoms. This rate increases even more during pregnancy. There are a number of studies examining the role of anxiety symptoms on fetal outcome, but the mechanisms that explain the effects of maternal stress are not fully understood.

The most extensively studied cytokines in neuropsychiatric disorders are TNF-α and IL-6 due to their effects on the central nervous system. TNF-α levels have been reported to be elevated in anxiety disorders. In our study, the investigators aimed to determine the relationship between preoperative anxiety levels and fetal cord blood TNF-α and IL-6 cytokine levels in pregnant women.

Condition or Disease Intervention/Treatment Phase
  • Other: Preoperative anxiety levels

Detailed Description

This prospective observational study is planned to involve 30 volunteer patients between 18-40 years of age who will undergo elective caesarean section surgery. People with known psychiatric illness and medication use, illiterate, who do not have mental competence to understand survey questions and very urgent patients will not be included in the study.

Preoperative anxiety levels will be determined by the STAI-Continuity scale at the time of admission to the anesthesia outpatient clinic and by the STAI-State scale 1 hour before surgery.The scales will be scored as normal, mild, moderate and severe anxiety. Psychiatric consultation will be requested for patients with severe anxiety. At the end of the cesarean section, the concentration of TNF-α and IL-6 cytokines in the blood remaining from routine blood gas taken from the umbilical cord will be determined to obtain information about the state of fetal well-being.

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Preoperative Anxiety on Fetal Cord Blood Tumor Necrosis Factor-Alpha and Interleukin-6 Levels in Pregnant Women
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
May 15, 2020
Actual Study Completion Date :
Jul 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Low anxiety, Middle and High anxiety

State Trait Anxiety İndex Scale: Values of less than 60, Low anxiety State Trait Anxiety İndex Scale: Values above 60, Middle and High anxiety

Other: Preoperative anxiety levels
Serums were separated from blood samples taken from all patients in the study, Using the anti-human TNF-α and IL-6 enzyme-linked immunosorbent assay (ELISA) kits in the Elisa device, the TNF-α and IL-6 cytokines will be measured to determine their concentration. No routine blood will be drawn during the procedures. Preoperative anxiety levels will be evaluated with STAI-Continuity and STAI-Statefulness scale.
Other Names:
  • Tumor Necrosis Factor-Alfa and İnterleukin-6 cytokine concentrations in fetal cord blood
  • Outcome Measures

    Primary Outcome Measures

    1. Correlation between preoperative anxiety level and fetal cord blood Tumor Necrosis Factor-Alfa and İnterleukin-6 cytokine levels [1 Day]

      Preoperative anxiety levels:anesthesia outpatient clinic with STAI-Continuity Scale and 1 hour before surgery with the STAI-State scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Between 18-40 years

    • Undergo elective caesarean section surgery

    • Volunteer patients

    Exclusion Criteria:
    • People with known psychiatric illness and medication use

    • Who do not have mental competence to understand survey questions

    • Very urgent patients

    • İlliterate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yozgat Bozok University Yozgat Turkey

    Sponsors and Collaborators

    • Bozok University

    Investigators

    • Study Director: Yozgat Bozok University Research Hospital, Yozgat

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ökkeş Hakan Miniksar, Assistant Professor, Bozok University
    ClinicalTrials.gov Identifier:
    NCT04226573
    Other Study ID Numbers:
    • 2019.10.231
    First Posted:
    Jan 13, 2020
    Last Update Posted:
    Dec 3, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ökkeş Hakan Miniksar, Assistant Professor, Bozok University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 3, 2020