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Effect of Preoperative Anxiety on Fetus in Pregnant Women

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ClinicalTrials.gov Identifier: NCT04226573
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Ökkeş Hakan Miniksar, Bozok University

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.


Condition or disease Intervention/treatment
Preoperative Anxiety Cytokines Other: Preoperative anxiety levels

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Preoperative Anxiety on Fetal Cord Blood Tumor Necrosis Factor-Alpha and Interleukin-6 Levels in Pregnant Women
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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
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.

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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Elective caesarean section surgery
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226573


Contacts
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Contact: Ökkeş Hakan Miniksar 5304686718 hminiksar@yahoo.com
Contact: Ayşe Yeşim Göçmen 5304686718 yesimgocmen@hotmail.com

Sponsors and Collaborators
Bozok University
Investigators
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Study Director: Yozgat Bozok University Research Hospital Yozgat

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Responsible Party: Ökkeş Hakan Miniksar, Assistant Professor, Bozok University
ClinicalTrials.gov Identifier: NCT04226573    
Other Study ID Numbers: 2019.10.231
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ökkeş Hakan Miniksar, Bozok University:
Preoperative anxiety
Umbilical cord blood
Cytokines
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders