Effect of Preoperative Anxiety on Fetus in Pregnant Women

Preoperative Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04226573
• Other study ID #: 2019.10.231
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: July 15, 2020

Study information

• Verified date: December 2020
• Source: Bozok University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

• Illiterate

Related Conditions & MeSH terms

• Anxiety Disorders
• Cytokines
• Preoperative Anxiety

Intervention

Other:
• Preoperative anxiety levels
Serums were separated from blood samples taken from all patients in the study, Using the anti-human TNF-a and IL-6 enzyme-linked immunosorbent assay (ELISA) kits in the Elisa device, the TNF-a 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.

Locations

Country	Name	City	State
Turkey	Yozgat Bozok University	Yozgat

Sponsors (1)

Lead Sponsor	Collaborator
Bozok University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between preoperative anxiety level and fetal cord blood Tumor Necrosis Factor-Alfa and Interleukin-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