Effect of Preoperative Anxiety on Fetus in Pregnant Women

Completed

• Conditions: Preoperative Anxiety; Cytokines
• Interventions: Other: Preoperative anxiety levels

• Registration Number: NCT04226573
• Lead Sponsor: Bozok University

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.

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 Timeline

• Study First Submitted: 2019-12-11
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2020-02-01
• Primary Completion: 2020-05-15
• Study Completion: 2020-07-15
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low anxiety, Middle and High anxiety	Preoperative anxiety levels	State Trait Anxiety İndex Scale: Values of less than 60, Low anxiety State Trait Anxiety İndex Scale: Values above 60, Middle and High anxiety

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Yozgat Bozok University; 🇹🇷 Yozgat, Turkey