Clinical trial NCT04226573: Effect of Preoperative Anxiety on Fetus in Pregnant Women
Official title: The Effect of Preoperative Anxiety on Fetal Cord Blood Tumor Necrosis Factor-Alpha and Interleukin-6 Levels in Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preoperative Anxiety
Cytokines
Keywords: Preoperative anxiety
Umbilical cord blood
Cytokines
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between preoperative anxiety level and fetal cord blood Tumor Necrosis Factor-Alfa and İnterleukin-6 cytokine levels
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Yozgat
country: Turkey
facility: Yozgat Bozok University
Study officials:
affiliation: Yozgat
name: Yozgat Bozok University Research Hospital
role: STUDY_DIRECTOR
References: