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NCT Number: NCT04226573

Effect of Preoperative Anxiety on Fetus 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.

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Key information

Conditions

Preoperative Anxiety Cytokines

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Yozgat Bozok University

Yozgat, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Tumor Necrosis Factor-Alfa and İnterleukin-6 cytokine concentrations in fetal cord blood

Primary outcomes

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

    Time frame: 1 Day

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

Sponsors and collaborators

Lead sponsor

Bozok University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2020
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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