Effect of Preoperative Anxiety on Fetus in Pregnant Women

NCT04226573 | Completed

• 1 other identifier: 2019.10.231
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Preoperative Anxiety; Cytokines

Keywords

Preoperative anxiety; Umbilical cord blood; Cytokines

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Preoperative anxiety levels OTHER

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.

Also known as: Tumor Necrosis Factor-Alfa and İnterleukin-6 cytokine concentrations in fetal cord blood

Low anxiety, Middle and High anxiety

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Elective caesarean section surgery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Between 18-40 years
• Undergo elective caesarean section surgery
• Volunteer patients

You may not qualify if:

• People with known psychiatric illness and medication use
• Who do not have mental competence to understand survey questions
• Very urgent patients
• İlliterate

Sponsors & Collaborators

• Bozok University: lead

Study Sites (1)

Yozgat Bozok University

Yozgat, Turkey (Türkiye)

Location

Study Officials

• Yozgat Bozok University Research Hospital

  Yozgat

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: January 13, 2020
• Study Start: February 1, 2020
• Primary Completion: May 15, 2020
• Study Completion: July 15, 2020
• Last Updated: December 3, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)