Efficacy of Counseling for Prenatal Screening and Diagnostic Tests on Pregnant Women: Randomised Controlled Study
Condition: Decision Making; Chromosome Abnormality; Anxiety; Knowledge, Attitudes, Practice
MeSH terms: Chromosome Disorders; Chromosome Aberrations; Anxiety Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Prenatal Genetic Counseling
Intervention type(s): Behavioral
Intervention description(s): In this study prenatal genetic screening counseling was provided from the begining of the pregnancy, different from the other studies in the literature. In the literature, most of the study evaluated pregnant women's anxiety, information status about the test and decisional conflicts, only prenatal screening process or prenatal diagnosis process. In this study pregnant women were evaluated both in prenatal screening test and prenatal diagnosis procedures.
Other intervention name(s): Counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: prenatal genetic screening; prenatal diagnosis; counseling; decision; anxiety; nursing