<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03825978</url>
  </required_header>
  <id_info>
    <org_study_id>Ilknur Yesilcinar</org_study_id>
    <nct_id>NCT03825978</nct_id>
  </id_info>
  <brief_title>Efficacy of Counseling for Prenatal Screening and Diagnostic Tests on Pregnant Women: Randomised Controlled Study</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to evaluate the effect of counseling for prenatal screening and&#xD;
      diagnostic tests on pregnant women's decisional conflict, being sure of the decision, anxiety&#xD;
      levels, and attitudes towards the tests. This prospective randomized controlled intervention&#xD;
      study was conducted between the dates June 2017 and March 2018 in a training and research&#xD;
      hospital, department of obstetrics and gynecology. The sample of the study consisted of 210&#xD;
      pregnant women who took antenatal care between the 8-11th gestational weeks of whom 112 were&#xD;
      in the intervention group and 98 were in the control group. The data were collected by using&#xD;
      Data Collection Form, The State-Trait Anxiety Inventory (STAI I-II), Decisional Conflict&#xD;
      Scale (DCS), Sure Scale (SURE), Knowledge Evaluation Form about Prenatal Genetic Screening&#xD;
      and Diagnostic Tests, Prenatal Counseling Satisfaction Form, Decision Satisfaction Form and&#xD;
      Attitudes towards the tests Scale. The study carried out in two stages. In the first stage;&#xD;
      women's data were collected before and after participating prenatal genetic screening tests.&#xD;
      After the results of the screening test were taken, the data were collected again. Counseling&#xD;
      was provided for 112 pregnant women about prenatal screening and diagnostic tests before&#xD;
      participating tests. Routine clinical information was given for 98 pregnant women who were in&#xD;
      control group. Both groups were pre and post-tested at the same times. In the second phase,&#xD;
      pregnant women who had diagnostic tests were evaluated. Counseling for prenatal genetic&#xD;
      diagnosis tests was provided for 31 pregnant women in inetervetion group women and routine&#xD;
      clinical information was providen for 26 pregnant women who were in control group. Data were&#xD;
      collected again with data collection tools before and after the diagnostic test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregnant Women Who Had Only Prenatal Genetic Screening Tests In intervention group, pregnant&#xD;
      women, who were in 8-11th gestational weeks, before prenatal genetic counseling, answered the&#xD;
      questions in &quot;Descriptive Features Data Collection Form&quot;, &quot;Decisional Conflict Scale&quot;, &quot;The&#xD;
      State-Trait Anxiety Inventory scale&quot;, &quot;Information Evaluation Form about Prenatal Screening&#xD;
      Tests &quot;,&quot;Decision Satisfaction Scale&quot;, &quot;Attitudes towards the tests Scale&quot;. Later, individual&#xD;
      interviews were made with pregnant women education was given with slide show about prenatal&#xD;
      diagnosis and screening tests to pregnant women. In addition a training brochure which was&#xD;
      prepared by the researcher was given to the pregnant women. It took about 20 minutes for the&#xD;
      data collection forms to be answered and counseling was took about 25 minutes. After&#xD;
      counseling, pregnant women were interviewed again at 14th week. The pregnant women were asked&#xD;
      whether they had a screening test and the results were recorded. Then pregnant women were&#xD;
      answered &quot;Decisional Conflict Scale&quot;, &quot;The State-Trait Anxiety Inventory scale&quot;, &quot;Information&#xD;
      Evaluation Form about Prenatal Screening Tests &quot;,&quot;Decision Satisfaction Scale&quot;, &quot;Attitudes&#xD;
      towards the tests Scale&quot; again. At the following antenatal visits (16-20th weeks), the&#xD;
      pregnant women were asked whether they had triple, quadruple or NIPT and the test results&#xD;
      were recorded in the data collection form. At the end of the 20th week, the data collection&#xD;
      process of pregnant women who did not have any problems related to fetus and who were&#xD;
      recommended to continue routine follow-up was terminated. In control group pregnant women&#xD;
      answered same data collection forms in same weeks, but counseling was not given to this&#xD;
      group. For this group routine clinical procedure was performed.&#xD;
&#xD;
      Pregnant Women Who Had Also Prenatal Genetic Diagnostic Tests Prenatal genetic diagnostic&#xD;
      tests were recommended to pregnant women who had high risk results according to prenatal&#xD;
      screening test. Pregnant women with high risk and diagnostic test were referred to genetic&#xD;
      consultation in both intervention and control groups. After genetic consultation, pregnant&#xD;
      women were answered &quot;Decisional Conflict Scale&quot;, &quot;The State-Trait Anxiety Inventory scale&quot;,&#xD;
      &quot;Information Evaluation Form about Prenatal Diagnostic Tests&quot;, &quot;Decision Satisfaction Scale&quot;,&#xD;
      &quot;Attitudes towards the tests Scale&quot;. Then specific counseling was given to invasive test&#xD;
      recommended by the doctor. The pregnant woman was asked if she would like to have a&#xD;
      diagnostic test and if she didn't want to, the reason was recorded in the data collection&#xD;
      form.&#xD;
&#xD;
      If the pregnant woman decided to have a diagnostic test, &quot;The State-Trait Anxiety Inventory&#xD;
      scale&quot; was applied again after the procedure. Then pregnant women were interviewed again&#xD;
      after about three weeks and their results were evaluated and they answered &quot;Decisional&#xD;
      Conflict Scale&quot;, &quot;Information Evaluation Form about Prenatal Diagnostic Tests&quot;, &quot;Decision&#xD;
      Satisfaction Scale&quot;, &quot;Attitudes towards the tests Scale&quot;. Their decision about to continue or&#xD;
      terminate pregnancy was recorded in the data collection form. In control group pregnant women&#xD;
      answered same data collection forms in same weeks, but counseling was not given to this&#xD;
      group. For this group routine clinical procedure was performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2017</start_date>
  <completion_date type="Actual">March 5, 2018</completion_date>
  <primary_completion_date type="Actual">March 5, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>In 8-11th gestational weeks</time_frame>
    <description>The State Anxiety Scale evaluates the current state of anxiety. The expressions (1) in the articles are rated as (2) slightly, (3) very, (4) completely, and the scale is answered by marking the ones that meet the current situation of the person. The total point value obtained from scale may vary between 20 and 80 points. High score indicates high anxiety level and low score indicates low anxiety level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decisional Conflict</measure>
    <time_frame>In 8-11th gestational weeks</time_frame>
    <description>Pregnant women's decisional conflict scale points: 5-point Likert type and 16 questions.&#xD;
Each item varies between &quot;Strongly Agree ıy and&quot; Strongly Disagree Her. Each item contains direct expressions, and I absolutely agree with = 0 points, Agree = 1 points, Undecided = 2 points, Disagree = 3 points and Strongly Disagree = 4 points. While calculating the total scale score; points are awarded to all items. The score is divided by the total number of items and is multiplied by 25 and the scale score is obtained. There is no cut-off point in the scale evaluating decision conflict scores. As the score obtained from the scale increases, the level of decision conflict increases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SURE Scale</measure>
    <time_frame>In 8-11th gestational weeks</time_frame>
    <description>Pregnant women's SURE Scale points: It is double likert type. Items Yes = 1 point No = 0 points. Zero points mean that there is a very high decision-making conflict, while 4 points mean that there is no conflict. Scores of 3 points or less indicate a conflict of interest.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge Form About Prenatal Genetic Screening and Diagnostic Tests</measure>
    <time_frame>In 8-11th gestational weeks</time_frame>
    <description>Pregnant Women's Prenatal Genetic Screening and Diagnostic Tests Form points: The information evaluation form for prenatal screening tests was developed by the researcher as a result of literature review. The information evaluation form for prenatal screening tests consists of 12 statements. The aim of the prenatal screening tests is to provide information about the diseases, the weeks of screening tests, risk values and what they mean. For each phrase there are yes, I don't know and no options.Twelve is Highest, 0 is the lowest scores.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attitudes Towards The Tests Scale</measure>
    <time_frame>In 8-11th gestational weeks</time_frame>
    <description>Pregnant women's Attitudes Towards The Tests scale points: Good idea to participate in testing for prenatal screening and diagnostic tests on the scale (7 points), bad idea (1 point); useful (7 points), not useful (1 point); harmful (1 point), not harmful (7 points); a bad idea (1 point), not a bad idea (7 points) were asked to rank between 1 and 7 points. One point represents negative attitude and 7 points represent a very positive attitude. According to the opinions of the pregnant women about the prenatal screening and diagnostic tests, it was stated that they could give the expressions between 1 and 7, and they were asked to answer the scale. The highest score to be obtained from this scale is 28 and the lowest score is 4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Decision Satisfaction Form</measure>
    <time_frame>In 8-11th gestational weeks</time_frame>
    <description>Pregnant women's Decision Satisfaction Form points: Developed by researchers. The participants were asked to evaluate whether they were satisfied with their decisions, to make an informed decision, to make informed decisions, to make the same decision if they had experienced the same situation again. In this form, which consists of five questions and has a five-point Likert type, the expressions are evaluated with 5 (strongly agree), 4 (agree), 3 (unclear), 2 (disagree), 1 (strongly disagree) options. The highest 25 points are the lowest 5 points. High score shows high satisfaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>In 13-14th gestational weeks</time_frame>
    <description>The State Anxiety Scale evaluates the current state of anxiety. The expressions (1) in the articles are rated as (2) slightly, (3) very, (4) completely, and the scale is answered by marking the ones that meet the current situation of the person. The total point value obtained from scale may vary between 20 and 80 points. High score indicates high anxiety level and low score indicates low anxiety level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional Conflict Scale</measure>
    <time_frame>In 13-14th gestational weeks</time_frame>
    <description>Pregnant women's decisional conflict scale points: 5-point Likert type and 16 questions.&#xD;
Each item varies between &quot;Strongly Agree ıy and&quot; Strongly Disagree Her. Each item contains direct expressions, and I absolutely agree with = 0 points, Agree = 1 points, Undecided = 2 points, Disagree = 3 points and Strongly Disagree = 4 points. While calculating the total scale score; points are awarded to all items. The score is divided by the total number of items and is multiplied by 25 and the scale score is obtained. There is no cut-off point in the scale evaluating decision conflict scores. As the score obtained from the scale increases, the level of decision conflict increases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SURE Scale</measure>
    <time_frame>In 13-14th gestational weeks</time_frame>
    <description>Pregnant women's SURE Scale points: It is double likert type. Items Yes = 1 point No = 0 points. Zero points mean that there is a very high decision-making conflict, while 4 points mean that there is no conflict. Scores of 3 points or less indicate a conflict of interest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge Form About Prenatal Genetic Screening and Diagnostic Tests</measure>
    <time_frame>In 13-14th gestational weeks</time_frame>
    <description>Pregnant women's Knowledge About Prenatal Genetic Screening and Diagnostic Tests Form Points: The information evaluation form for prenatal screening tests was developed by the researcher as a result of literature review. The information evaluation form for prenatal screening tests consists of 12 statements. The aim of the prenatal screening tests is to provide information about the diseases, the weeks of screening tests, risk values and what they mean. For each phrase there are yes, I don't know and no options. Twelve is Highest, 0 is the lowest scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes Towards The Tests Scale</measure>
    <time_frame>In 13-14th gestational weeks</time_frame>
    <description>Pregnant women's Attitudes Towards The Tests Scale Points: Good idea to participate in testing for prenatal screening and diagnostic tests on the scale (7 points), bad idea (1 point); useful (7 points), not useful (1 point); harmful (1 point), not harmful (7 points); a bad idea (1 point), not a bad idea (7 points) were asked to rank between 1 and 7 points. One point represents negative attitude and 7 points represent a very positive attitude. According to the opinions of the pregnant women about the prenatal screening and diagnostic tests, it was stated that they could give the expressions between 1 and 7, and they were asked to answer the scale. The highest score to be obtained from this scale is 28 and the lowest score is 4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decision Satisfaction Form</measure>
    <time_frame>In 13-14th gestational weeks</time_frame>
    <description>Pregnant Women's Decision Satisfaction Form Points: Developed by researchers. The participants were asked to evaluate whether they were satisfied with their decisions, to make an informed decision, to make informed decisions, to make the same decision if they had experienced the same situation again. In this form, which consists of five questions and has a five-point Likert type, the expressions are evaluated with 5 (strongly agree), 4 (agree), 3 (unclear), 2 (disagree), 1 (strongly disagree) options. The highest 25 points are the lowest 5 points. High score shows high satisfaction.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Decisional Conflict Scale</measure>
    <time_frame>Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)</time_frame>
    <description>Pregnant women's Decisional Conflict Scale points: 5-point Likert type and 16 questions.&#xD;
Each item varies between &quot;Strongly Agree ıy and&quot; Strongly Disagree Her. Each item contains direct expressions, and I absolutely agree with = 0 points, Agree = 1 points, Undecided = 2 points, Disagree = 3 points and Strongly Disagree = 4 points. While calculating the total scale score; points are awarded to all items. The score is divided by the total number of items and is multiplied by 25 and the scale score is obtained. There is no cut-off point in the scale evaluating decision conflict scores. As the score obtained from the scale increases, the level of decision conflict increases.</description>
  </other_outcome>
  <other_outcome>
    <measure>SURE Scale</measure>
    <time_frame>Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)</time_frame>
    <description>Pregnant women's SURE Scale points: It is double likert type. Items Yes = 1 point No = 0 points. Zero points mean that there is a very high decision-making conflict, while 4 points mean that there is no conflict. Scores of 3 points or less indicate a conflict of interest.</description>
  </other_outcome>
  <other_outcome>
    <measure>Knowledge Form About Prenatal Genetic Diagnostic Tests</measure>
    <time_frame>Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)</time_frame>
    <description>Pregnant women's Knowledge About Prenatal Genetic Diagnostic Tests Form points: The information evaluation form for prenatal diagnostic tests was developed by the researcher as a result of literature review. The information evaluation form for prenatal diagnostic tests consists of 10 statements. The aim of this form is to provide information about the diseases, the weeks of diagnostic tests, tests' aims and what they mean. For each phrase there are yes, I don't know and no options. Ten is Highest, 0 is the lowest scores.</description>
  </other_outcome>
  <other_outcome>
    <measure>Attitudes Towards The Tests Scale</measure>
    <time_frame>Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)</time_frame>
    <description>Pregnant women's Attitudes Towards The Tests Scale points: Good idea to participate in testing for prenatal screening and diagnostic tests on the scale (7 points), bad idea (1 point); useful (7 points), not useful (1 point); harmful (1 point), not harmful (7 points); a bad idea (1 point), not a bad idea (7 points) were asked to rank between 1 and 7 points. One point represents negative attitude and 7 points represent a very positive attitude. According to the opinions of the pregnant women about the prenatal screening and diagnostic tests, it was stated that they could give the expressions between 1 and 7, and they were asked to answer the scale. The highest score to be obtained from this scale is 28 and the lowest score is 4.</description>
  </other_outcome>
  <other_outcome>
    <measure>Decision Satisfaction Form</measure>
    <time_frame>Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)</time_frame>
    <description>Pregnant women's Decision Satisfaction Form points:Developed by researchers. The participants were asked to evaluate whether they were satisfied with their decisions, to make an informed decision, to make informed decisions, to make the same decision if they had experienced the same situation again. In this form, which consists of five questions and has a five-point Likert type, the expressions are evaluated with 5 (strongly agree), 4 (agree), 3 (unclear), 2 (disagree), 1 (strongly disagree) options. The highest 25 points are the lowest 5 points. High score shows high satisfaction.</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety</measure>
    <time_frame>Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)</time_frame>
    <description>The State Anxiety Scale evaluates the current state of anxiety. The expressions (1) in the articles are rated as (2) slightly, (3) very, (4) completely, and the scale is answered by marking the ones that meet the current situation of the person. The total point value obtained from scale may vary between 20 and 80 points. High score indicates high anxiety level and low score indicates low anxiety level</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety</measure>
    <time_frame>After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)</time_frame>
    <description>The State Anxiety Scale evaluates the current state of anxiety. The expressions (1) in the articles are rated as (2) slightly, (3) very, (4) completely, and the scale is answered by marking the ones that meet the current situation of the person. The total point value obtained from scale may vary between 20 and 80 points. High score indicates high anxiety level and low score indicates low anxiety level</description>
  </other_outcome>
  <other_outcome>
    <measure>Decisional Conflict Scale</measure>
    <time_frame>After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)</time_frame>
    <description>Pregnant women's Decisional Conflict Scale points: 5-point Likert type and 16 questions.&#xD;
Each item varies between &quot;Strongly Agree ıy and&quot; Strongly Disagree Her. Each item contains direct expressions, and I absolutely agree with = 0 points, Agree = 1 points, Undecided = 2 points, Disagree = 3 points and Strongly Disagree = 4 points. While calculating the total scale score; points are awarded to all items. The score is divided by the total number of items and is multiplied by 25 and the scale score is obtained. There is no cut-off point in the scale evaluating decision conflict scores. As the score obtained from the scale increases, the level of decision conflict increases.</description>
  </other_outcome>
  <other_outcome>
    <measure>SURE Scale</measure>
    <time_frame>After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)</time_frame>
    <description>Pregnant women's SURE Scale points: It is double likert type. Items Yes = 1 point No = 0 points. Zero points mean that there is a very high decision-making conflict, while 4 points mean that there is no conflict. Scores of 3 points or less indicate a conflict of interest.</description>
  </other_outcome>
  <other_outcome>
    <measure>Knowledge Form About Prenatal Genetic Diagnostic Tests</measure>
    <time_frame>After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)</time_frame>
    <description>Pregnant women's Knowledge About Prenatal Genetic Diagnostic Tests Form points: The information evaluation form for prenatal diagnostic tests was developed by the researcher as a result of literature review. The information evaluation form for prenatal diagnostic tests consists of 10 statements. The aim of this form is to provide information about the diseases, the weeks of diagnostic tests, tests' aims and what they mean. For each phrase there are yes, I don't know and no options. Ten is Highest, 0 is the lowest scores.</description>
  </other_outcome>
  <other_outcome>
    <measure>Attitudes Towards The Tests Scale</measure>
    <time_frame>After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)</time_frame>
    <description>Pregnant women's Attitudes Towards The Tests Scale points: Good idea to participate in testing for prenatal screening and diagnostic tests on the scale (7 points), bad idea (1 point); useful (7 points), not useful (1 point); harmful (1 point), not harmful (7 points); a bad idea (1 point), not a bad idea (7 points) were asked to rank between 1 and 7 points. One point represents negative attitude and 7 points represent a very positive attitude. According to the opinions of the pregnant women about the prenatal screening and diagnostic tests, it was stated that they could give the expressions between 1 and 7, and they were asked to answer the scale. The highest score to be obtained from this scale is 28 and the lowest score is 4.</description>
  </other_outcome>
  <other_outcome>
    <measure>Decision Satisfaction Form</measure>
    <time_frame>After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)</time_frame>
    <description>Pregnant women's Decision Satisfaction Form points: Developed by researchers. The participants were asked to evaluate whether they were satisfied with their decisions, to make an informed decision, to make informed decisions, to make the same decision if they had experienced the same situation again. In this form, which consists of five questions and has a five-point Likert type, the expressions are evaluated with 5 (strongly agree), 4 (agree), 3 (unclear), 2 (disagree), 1 (strongly disagree) options. The highest 25 points are the lowest 5 points. High score shows high satisfaction.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Decision Making</condition>
  <condition>Chromosome Abnormality</condition>
  <condition>Anxiety</condition>
  <condition>Knowledge, Attitudes, Practice</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An individual and comprehensive prenatal genetic counseling was given to all pregnant women in the intervention group, including all screening tests and diagnostic tests for prenatal diagnosis and screening tests at the first antenatal visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>There was no intervention from the first antenatal visit in the control group. Routine clinical information was given about prenatal screening and diagnostic tests.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Prenatal Genetic Counseling</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Counseling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  taking first antenatal follow-up in 8-11. gestational weeks in where the study is&#xD;
             conducted to have a single pregnancy&#xD;
&#xD;
          -  to continue take the antenatal care in the hospital where the research was conducted&#xD;
&#xD;
          -  at least primary school graduation,&#xD;
&#xD;
          -  voluntary to participate the research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  want to exit from the study at her own request&#xD;
&#xD;
          -  continue to antenatal follow-up in another hospital.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women was evaluated in this study</gender_description>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>İlknur Yeşilçınar, PhD. RN.</last_name>
    <role>Study Director</role>
    <affiliation>Health Science University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gülten Güvenç, Assoc. Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Health Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Science University</name>
      <address>
        <city>Ankara</city>
        <zip>06010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Health Sciences</name>
      <address>
        <city>Ankara</city>
        <zip>06010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Martin L, Gitsels-van der Wal JT, de Boer MA, Vanstone M, Henneman L. Introduction of non-invasive prenatal testing as a first-tier aneuploidy screening test: A survey among Dutch midwives about their role as counsellors. Midwifery. 2018 Jan;56:1-8. doi: 10.1016/j.midw.2017.09.008. Epub 2017 Sep 24.</citation>
    <PMID>29024868</PMID>
  </reference>
  <reference>
    <citation>Amel S.H., Ali A, Hassan S.A, Momtaz M., Abdelhaleem Z., Negm S. Impact of A Structured Prenatal Counseling on Anxiety Level Among Women Undergoing Amniocentesis. American Journal of Research Communication, 2014; 2(6): 97-108} www.usa-journals.com, ISSN: 2325-4076.</citation>
  </reference>
  <results_reference>
    <citation>Long S, O'Leary P, Lobo R, Dickinson JE. Women's Understanding and Attitudes towards Down Syndrome and Other Genetic Conditions in the Context of Prenatal Screening. J Genet Couns. 2018 Jun;27(3):647-655. doi: 10.1007/s10897-017-0167-7. Epub 2017 Oct 24.</citation>
    <PMID>29067542</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Saglik Bilimleri Universitesi Gulhane Tip Fakultesi</investigator_affiliation>
    <investigator_full_name>Ilknur Yesilcinar</investigator_full_name>
    <investigator_title>PhD. RN., Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>prenatal genetic screening</keyword>
  <keyword>prenatal diagnosis</keyword>
  <keyword>counseling</keyword>
  <keyword>decision</keyword>
  <keyword>anxiety</keyword>
  <keyword>nursing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chromosome Disorders</mesh_term>
    <mesh_term>Chromosome Aberrations</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03825978
org study id: Ilknur Yesilcinar
nct id: NCT03825978
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Anxiety
time frame: In 8-11th gestational weeks
description: The State Anxiety Scale evaluates the current state of anxiety. The expressions (1) in the articles are rated as (2) slightly, (3) very, (4) completely, and the scale is answered by marking the ones that meet the current situation of the person. The total point value obtained from scale may vary between 20 and 80 points. High score indicates high anxiety level and low score indicates low anxiety level
measure: Decisional Conflict
time frame: In 8-11th gestational weeks
description: Pregnant women's decisional conflict scale points: 5-point Likert type and 16 questions.
Each item varies between "Strongly Agree ıy and" Strongly Disagree Her. Each item contains direct expressions, and I absolutely agree with = 0 points, Agree = 1 points, Undecided = 2 points, Disagree = 3 points and Strongly Disagree = 4 points. While calculating the total scale score; points are awarded to all items. The score is divided by the total number of items and is multiplied by 25 and the scale score is obtained. There is no cut-off point in the scale evaluating decision conflict scores. As the score obtained from the scale increases, the level of decision conflict increases.
measure: SURE Scale
time frame: In 8-11th gestational weeks
description: Pregnant women's SURE Scale points: It is double likert type. Items Yes = 1 point No = 0 points. Zero points mean that there is a very high decision-making conflict, while 4 points mean that there is no conflict. Scores of 3 points or less indicate a conflict of interest.
measure: Knowledge Form About Prenatal Genetic Screening and Diagnostic Tests
time frame: In 8-11th gestational weeks
description: Pregnant Women's Prenatal Genetic Screening and Diagnostic Tests Form points: The information evaluation form for prenatal screening tests was developed by the researcher as a result of literature review. The information evaluation form for prenatal screening tests consists of 12 statements. The aim of the prenatal screening tests is to provide information about the diseases, the weeks of screening tests, risk values and what they mean. For each phrase there are yes, I don't know and no options.Twelve is Highest, 0 is the lowest scores.
measure: Attitudes Towards The Tests Scale
time frame: In 8-11th gestational weeks
description: Pregnant women's Attitudes Towards The Tests scale points: Good idea to participate in testing for prenatal screening and diagnostic tests on the scale (7 points), bad idea (1 point); useful (7 points), not useful (1 point); harmful (1 point), not harmful (7 points); a bad idea (1 point), not a bad idea (7 points) were asked to rank between 1 and 7 points. One point represents negative attitude and 7 points represent a very positive attitude. According to the opinions of the pregnant women about the prenatal screening and diagnostic tests, it was stated that they could give the expressions between 1 and 7, and they were asked to answer the scale. The highest score to be obtained from this scale is 28 and the lowest score is 4.
measure: Decision Satisfaction Form
time frame: In 8-11th gestational weeks
description: Pregnant women's Decision Satisfaction Form points: Developed by researchers. The participants were asked to evaluate whether they were satisfied with their decisions, to make an informed decision, to make informed decisions, to make the same decision if they had experienced the same situation again. In this form, which consists of five questions and has a five-point Likert type, the expressions are evaluated with 5 (strongly agree), 4 (agree), 3 (unclear), 2 (disagree), 1 (strongly disagree) options. The highest 25 points are the lowest 5 points. High score shows high satisfaction.
measure: Anxiety
time frame: In 13-14th gestational weeks
description: The State Anxiety Scale evaluates the current state of anxiety. The expressions (1) in the articles are rated as (2) slightly, (3) very, (4) completely, and the scale is answered by marking the ones that meet the current situation of the person. The total point value obtained from scale may vary between 20 and 80 points. High score indicates high anxiety level and low score indicates low anxiety level
measure: Decisional Conflict Scale
time frame: In 13-14th gestational weeks
description: Pregnant women's decisional conflict scale points: 5-point Likert type and 16 questions.
Each item varies between "Strongly Agree ıy and" Strongly Disagree Her. Each item contains direct expressions, and I absolutely agree with = 0 points, Agree = 1 points, Undecided = 2 points, Disagree = 3 points and Strongly Disagree = 4 points. While calculating the total scale score; points are awarded to all items. The score is divided by the total number of items and is multiplied by 25 and the scale score is obtained. There is no cut-off point in the scale evaluating decision conflict scores. As the score obtained from the scale increases, the level of decision conflict increases.
measure: SURE Scale
time frame: In 13-14th gestational weeks
description: Pregnant women's SURE Scale points: It is double likert type. Items Yes = 1 point No = 0 points. Zero points mean that there is a very high decision-making conflict, while 4 points mean that there is no conflict. Scores of 3 points or less indicate a conflict of interest.
measure: Knowledge Form About Prenatal Genetic Screening and Diagnostic Tests
time frame: In 13-14th gestational weeks
description: Pregnant women's Knowledge About Prenatal Genetic Screening and Diagnostic Tests Form Points: The information evaluation form for prenatal screening tests was developed by the researcher as a result of literature review. The information evaluation form for prenatal screening tests consists of 12 statements. The aim of the prenatal screening tests is to provide information about the diseases, the weeks of screening tests, risk values and what they mean. For each phrase there are yes, I don't know and no options. Twelve is Highest, 0 is the lowest scores.
measure: Attitudes Towards The Tests Scale
time frame: In 13-14th gestational weeks
description: Pregnant women's Attitudes Towards The Tests Scale Points: Good idea to participate in testing for prenatal screening and diagnostic tests on the scale (7 points), bad idea (1 point); useful (7 points), not useful (1 point); harmful (1 point), not harmful (7 points); a bad idea (1 point), not a bad idea (7 points) were asked to rank between 1 and 7 points. One point represents negative attitude and 7 points represent a very positive attitude. According to the opinions of the pregnant women about the prenatal screening and diagnostic tests, it was stated that they could give the expressions between 1 and 7, and they were asked to answer the scale. The highest score to be obtained from this scale is 28 and the lowest score is 4.
measure: Decision Satisfaction Form
time frame: In 13-14th gestational weeks
description: Pregnant Women's Decision Satisfaction Form Points: Developed by researchers. The participants were asked to evaluate whether they were satisfied with their decisions, to make an informed decision, to make informed decisions, to make the same decision if they had experienced the same situation again. In this form, which consists of five questions and has a five-point Likert type, the expressions are evaluated with 5 (strongly agree), 4 (agree), 3 (unclear), 2 (disagree), 1 (strongly disagree) options. The highest 25 points are the lowest 5 points. High score shows high satisfaction.
measure: Decisional Conflict Scale
time frame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
description: Pregnant women's Decisional Conflict Scale points: 5-point Likert type and 16 questions.
Each item varies between "Strongly Agree ıy and" Strongly Disagree Her. Each item contains direct expressions, and I absolutely agree with = 0 points, Agree = 1 points, Undecided = 2 points, Disagree = 3 points and Strongly Disagree = 4 points. While calculating the total scale score; points are awarded to all items. The score is divided by the total number of items and is multiplied by 25 and the scale score is obtained. There is no cut-off point in the scale evaluating decision conflict scores. As the score obtained from the scale increases, the level of decision conflict increases.
measure: SURE Scale
time frame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
description: Pregnant women's SURE Scale points: It is double likert type. Items Yes = 1 point No = 0 points. Zero points mean that there is a very high decision-making conflict, while 4 points mean that there is no conflict. Scores of 3 points or less indicate a conflict of interest.
measure: Knowledge Form About Prenatal Genetic Diagnostic Tests
time frame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
description: Pregnant women's Knowledge About Prenatal Genetic Diagnostic Tests Form points: The information evaluation form for prenatal diagnostic tests was developed by the researcher as a result of literature review. The information evaluation form for prenatal diagnostic tests consists of 10 statements. The aim of this form is to provide information about the diseases, the weeks of diagnostic tests, tests' aims and what they mean. For each phrase there are yes, I don't know and no options. Ten is Highest, 0 is the lowest scores.
measure: Attitudes Towards The Tests Scale
time frame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
description: Pregnant women's Attitudes Towards The Tests Scale points: Good idea to participate in testing for prenatal screening and diagnostic tests on the scale (7 points), bad idea (1 point); useful (7 points), not useful (1 point); harmful (1 point), not harmful (7 points); a bad idea (1 point), not a bad idea (7 points) were asked to rank between 1 and 7 points. One point represents negative attitude and 7 points represent a very positive attitude. According to the opinions of the pregnant women about the prenatal screening and diagnostic tests, it was stated that they could give the expressions between 1 and 7, and they were asked to answer the scale. The highest score to be obtained from this scale is 28 and the lowest score is 4.
measure: Decision Satisfaction Form
time frame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
description: Pregnant women's Decision Satisfaction Form points:Developed by researchers. The participants were asked to evaluate whether they were satisfied with their decisions, to make an informed decision, to make informed decisions, to make the same decision if they had experienced the same situation again. In this form, which consists of five questions and has a five-point Likert type, the expressions are evaluated with 5 (strongly agree), 4 (agree), 3 (unclear), 2 (disagree), 1 (strongly disagree) options. The highest 25 points are the lowest 5 points. High score shows high satisfaction.
measure: Anxiety
time frame: Before performing prenatal genetic diagnostic test at 16 weeks for who had amniosenthesis, 12 weeks for who had corionic villus sampling (For Women who had diagnostic tests)
description: The State Anxiety Scale evaluates the current state of anxiety. The expressions (1) in the articles are rated as (2) slightly, (3) very, (4) completely, and the scale is answered by marking the ones that meet the current situation of the person. The total point value obtained from scale may vary between 20 and 80 points. High score indicates high anxiety level and low score indicates low anxiety level
measure: Anxiety
time frame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
description: The State Anxiety Scale evaluates the current state of anxiety. The expressions (1) in the articles are rated as (2) slightly, (3) very, (4) completely, and the scale is answered by marking the ones that meet the current situation of the person. The total point value obtained from scale may vary between 20 and 80 points. High score indicates high anxiety level and low score indicates low anxiety level
measure: Decisional Conflict Scale
time frame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
description: Pregnant women's Decisional Conflict Scale points: 5-point Likert type and 16 questions.
Each item varies between "Strongly Agree ıy and" Strongly Disagree Her. Each item contains direct expressions, and I absolutely agree with = 0 points, Agree = 1 points, Undecided = 2 points, Disagree = 3 points and Strongly Disagree = 4 points. While calculating the total scale score; points are awarded to all items. The score is divided by the total number of items and is multiplied by 25 and the scale score is obtained. There is no cut-off point in the scale evaluating decision conflict scores. As the score obtained from the scale increases, the level of decision conflict increases.
measure: SURE Scale
time frame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
description: Pregnant women's SURE Scale points: It is double likert type. Items Yes = 1 point No = 0 points. Zero points mean that there is a very high decision-making conflict, while 4 points mean that there is no conflict. Scores of 3 points or less indicate a conflict of interest.
measure: Knowledge Form About Prenatal Genetic Diagnostic Tests
time frame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
description: Pregnant women's Knowledge About Prenatal Genetic Diagnostic Tests Form points: The information evaluation form for prenatal diagnostic tests was developed by the researcher as a result of literature review. The information evaluation form for prenatal diagnostic tests consists of 10 statements. The aim of this form is to provide information about the diseases, the weeks of diagnostic tests, tests' aims and what they mean. For each phrase there are yes, I don't know and no options. Ten is Highest, 0 is the lowest scores.
measure: Attitudes Towards The Tests Scale
time frame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
description: Pregnant women's Attitudes Towards The Tests Scale points: Good idea to participate in testing for prenatal screening and diagnostic tests on the scale (7 points), bad idea (1 point); useful (7 points), not useful (1 point); harmful (1 point), not harmful (7 points); a bad idea (1 point), not a bad idea (7 points) were asked to rank between 1 and 7 points. One point represents negative attitude and 7 points represent a very positive attitude. According to the opinions of the pregnant women about the prenatal screening and diagnostic tests, it was stated that they could give the expressions between 1 and 7, and they were asked to answer the scale. The highest score to be obtained from this scale is 28 and the lowest score is 4.
measure: Decision Satisfaction Form
time frame: After performing prenatal genetic diagnostic test at 20th weeks for who had amniosenthesis, 16 weeks for who had corionic villus sampling(For Women who had diagnostic tests)
description: Pregnant women's Decision Satisfaction Form points: Developed by researchers. The participants were asked to evaluate whether they were satisfied with their decisions, to make an informed decision, to make informed decisions, to make the same decision if they had experienced the same situation again. In this form, which consists of five questions and has a five-point Likert type, the expressions are evaluated with 5 (strongly agree), 4 (agree), 3 (unclear), 2 (disagree), 1 (strongly disagree) options. The highest 25 points are the lowest 5 points. High score shows high satisfaction.
arm group label: Intervention
arm group type: Active Comparator
description: An individual and comprehensive prenatal genetic counseling was given to all pregnant women in the intervention group, including all screening tests and diagnostic tests for prenatal diagnosis and screening tests at the first antenatal visit.
arm group label: Control
arm group type: No Intervention
description: There was no intervention from the first antenatal visit in the control group. Routine clinical information was given about prenatal screening and diagnostic tests.
intervention type: Behavioral
intervention name: Prenatal Genetic Counseling
description: 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.
arm group label: Intervention
other name: Counseling
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women was evaluated in this study
minimum age: 19 Years
maximum age: 46 Years
healthy volunteers: Accepts Healthy Volunteers
last name: İlknur Yeşilçınar, PhD. RN.
role: Study Director
affiliation: Health Science University
last name: Gülten Güvenç, Assoc. Prof.
role: Study Director
affiliation: Health Science University
facility: 
facility: 
country: Turkey
citation: Martin L, Gitsels-van der Wal JT, de Boer MA, Vanstone M, Henneman L. Introduction of non-invasive prenatal testing as a first-tier aneuploidy screening test: A survey among Dutch midwives about their role as counsellors. Midwifery. 2018 Jan;56:1-8. doi: 10.1016/j.midw.2017.09.008. Epub 2017 Sep 24.
PMID: 29024868
citation: Amel S.H., Ali A, Hassan S.A, Momtaz M., Abdelhaleem Z., Negm S. Impact of A Structured Prenatal Counseling on Anxiety Level Among Women Undergoing Amniocentesis. American Journal of Research Communication, 2014; 2(6): 97-108} www.usa-journals.com, ISSN: 2325-4076.
citation: Long S, O'Leary P, Lobo R, Dickinson JE. Women's Understanding and Attitudes towards Down Syndrome and Other Genetic Conditions in the Context of Prenatal Screening. J Genet Couns. 2018 Jun;27(3):647-655. doi: 10.1007/s10897-017-0167-7. Epub 2017 Oct 24.
PMID: 29067542
responsible party type: Principal Investigator
investigator affiliation: Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
investigator full name: Ilknur Yesilcinar
investigator title: PhD. RN., Principal Investigator
mesh term: Chromosome Disorders
mesh term: Chromosome Aberrations
mesh term: Anxiety Disorders
sharing ipd: No