Anxiety Clinical Trial
Official title:
Evaluation of Efficacy of Counseling for Prenatal Screening and Diagnostic Tests on Pregnant Women's Decisional Conflict, Being Sure of the Decision, Anxiety Levels and Attitudes Towards the Tests: A Randomised Controlled Clinical Study
The aim of this study was to evaluate the effect of counseling for prenatal screening and diagnostic tests on pregnant women's decisional conflict, being sure of the decision, anxiety levels, and attitudes towards the tests. This prospective randomized controlled intervention study was conducted between the dates June 2017 and March 2018 in a training and research hospital, department of obstetrics and gynecology. The sample of the study consisted of 210 pregnant women who took antenatal care between the 8-11th gestational weeks of whom 112 were in the intervention group and 98 were in the control group. The data were collected by using Data Collection Form, The State-Trait Anxiety Inventory (STAI I-II), Decisional Conflict Scale (DCS), Sure Scale (SURE), Knowledge Evaluation Form about Prenatal Genetic Screening and Diagnostic Tests, Prenatal Counseling Satisfaction Form, Decision Satisfaction Form and Attitudes towards the tests Scale. The study carried out in two stages. In the first stage; women's data were collected before and after participating prenatal genetic screening tests. After the results of the screening test were taken, the data were collected again. Counseling was provided for 112 pregnant women about prenatal screening and diagnostic tests before participating tests. Routine clinical information was given for 98 pregnant women who were in control group. Both groups were pre and post-tested at the same times. In the second phase, pregnant women who had diagnostic tests were evaluated. Counseling for prenatal genetic diagnosis tests was provided for 31 pregnant women in inetervetion group women and routine clinical information was providen for 26 pregnant women who were in control group. Data were collected again with data collection tools before and after the diagnostic test.
Pregnant Women Who Had Only Prenatal Genetic Screening Tests In intervention group, pregnant
women, who were in 8-11th gestational weeks, before prenatal genetic counseling, answered the
questions in "Descriptive Features Data Collection Form", "Decisional Conflict Scale", "The
State-Trait Anxiety Inventory scale", "Information Evaluation Form about Prenatal Screening
Tests ","Decision Satisfaction Scale", "Attitudes towards the tests Scale". Later, individual
interviews were made with pregnant women education was given with slide show about prenatal
diagnosis and screening tests to pregnant women. In addition a training brochure which was
prepared by the researcher was given to the pregnant women. It took about 20 minutes for the
data collection forms to be answered and counseling was took about 25 minutes. After
counseling, pregnant women were interviewed again at 14th week. The pregnant women were asked
whether they had a screening test and the results were recorded. Then pregnant women were
answered "Decisional Conflict Scale", "The State-Trait Anxiety Inventory scale", "Information
Evaluation Form about Prenatal Screening Tests ","Decision Satisfaction Scale", "Attitudes
towards the tests Scale" again. At the following antenatal visits (16-20th weeks), the
pregnant women were asked whether they had triple, quadruple or NIPT and the test results
were recorded in the data collection form. At the end of the 20th week, the data collection
process of pregnant women who did not have any problems related to fetus and who were
recommended to continue routine follow-up was terminated. In control group pregnant women
answered same data collection forms in same weeks, but counseling was not given to this
group. For this group routine clinical procedure was performed.
Pregnant Women Who Had Also Prenatal Genetic Diagnostic Tests Prenatal genetic diagnostic
tests were recommended to pregnant women who had high risk results according to prenatal
screening test. Pregnant women with high risk and diagnostic test were referred to genetic
consultation in both intervention and control groups. After genetic consultation, pregnant
women were answered "Decisional Conflict Scale", "The State-Trait Anxiety Inventory scale",
"Information Evaluation Form about Prenatal Diagnostic Tests", "Decision Satisfaction Scale",
"Attitudes towards the tests Scale". Then specific counseling was given to invasive test
recommended by the doctor. The pregnant woman was asked if she would like to have a
diagnostic test and if she didn't want to, the reason was recorded in the data collection
form.
If the pregnant woman decided to have a diagnostic test, "The State-Trait Anxiety Inventory
scale" was applied again after the procedure. Then pregnant women were interviewed again
after about three weeks and their results were evaluated and they answered "Decisional
Conflict Scale", "Information Evaluation Form about Prenatal Diagnostic Tests", "Decision
Satisfaction Scale", "Attitudes towards the tests Scale". Their decision about to continue or
terminate pregnancy was recorded in the data collection form. In control group pregnant women
answered same data collection forms in same weeks, but counseling was not given to this
group. For this group routine clinical procedure was performed.
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