- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04226573
Effect of Preoperative Anxiety on Fetus in Pregnant Women
The Effect of Preoperative Anxiety on Fetal Cord Blood Tumor Necrosis Factor-Alpha and Interleukin-6 Levels 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Yozgat, Turkey
- Yozgat Bozok University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between preoperative anxiety level and fetal cord blood Tumor Necrosis Factor-Alfa and İnterleukin-6 cytokine levels
Time Frame: 1 Day
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Preoperative anxiety levels:anesthesia outpatient clinic with STAI-Continuity Scale and 1 hour before surgery with the STAI-State scale.
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1 Day
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Yozgat Bozok University Research Hospital, Yozgat
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.10.231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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