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.
Full Title of Study: “The Effect of Preoperative Anxiety on Fetal Cord Blood Tumor Necrosis Factor-Alpha and Interleukin-6 Levels in Pregnant Women”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: April 15, 2020
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.
- 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.
Arms, Groups and Cohorts
- 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
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- Between 18-40 years
- Undergo elective caesarean section surgery
- Volunteer patients
- People with known psychiatric illness and medication use
- Who do not have mental competence to understand survey questions
- Very urgent patients
Gender Eligibility: Female
Elective caesarean section surgery
Minimum Age: 18 Years
Maximum Age: 40 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Bozok University
- Provider of Information About this Clinical Study
- Principal Investigator: Ökkeş Hakan Miniksar, Assistant Professor – Bozok University
- Overall Official(s)
- Yozgat Bozok University Research Hospital, Study Director, Yozgat
- Overall Contact(s)
- Ökkeş Hakan Miniksar, 5304686718, firstname.lastname@example.org
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