Effect of Preoperative Anxiety on Fetus in Pregnant Women

The Effect of Preoperative Anxiety on Fetal Cord Blood Tumor Necrosis Factor-Alpha and Interleukin-6 Levels in Pregnant Women

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.

Study Overview

• Status: Completed
• Conditions: Preoperative Anxiety; Cytokines
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Turkey
  • Yozgat, Turkey
    • Yozgat Bozok University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

This prospective observational study is planned to involve 30 volunteer patients between 18-40 years of age who will undergo elective caesarean section by Obstetrics and Gynecology Department.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between preoperative anxiety level and fetal cord blood Tumor Necrosis Factor-Alfa and İnterleukin-6 cytokine levels	Preoperative anxiety levels:anesthesia outpatient clinic with STAI-Continuity Scale and 1 hour before surgery with the STAI-State scale.	1 Day

Collaborators and Investigators

• Sponsor: Bozok University
• Investigators: Study Director: Yozgat Bozok University Research Hospital, Yozgat

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Cytokines; Preoperative anxiety; Umbilical cord blood
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2019.10.231

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No