Efficacy of Counseling for Prenatal Screening and Diagnostic Tests on Pregnant Women: Randomised Controlled Study

NCT03825978 | Completed DMC

• 1 other identifier: Ilknur Yesilcinar
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Decision Making; Chromosome Abnormality; Anxiety; Knowledge, Attitudes, Practice

Keywords

prenatal genetic screening; prenatal diagnosis; counseling; decision; anxiety; nursing

Outcome Measures

Primary Outcomes (6)

• Anxiety

  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

  In 8-11th gestational weeks

• Decisional Conflict

  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.

  In 8-11th gestational weeks

• SURE Scale

  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.

  In 8-11th gestational weeks

• Knowledge Form About Prenatal Genetic Screening and Diagnostic Tests

  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.

  In 8-11th gestational weeks

• Attitudes Towards The Tests Scale

  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.

  In 8-11th gestational weeks

• Decision Satisfaction Form

  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.

  In 8-11th gestational weeks

Secondary Outcomes (6)

• Anxiety

  In 13-14th gestational weeks

• Decisional Conflict Scale

  In 13-14th gestational weeks

• SURE Scale

  In 13-14th gestational weeks

• Knowledge Form About Prenatal Genetic Screening and Diagnostic Tests

  In 13-14th gestational weeks

• Attitudes Towards The Tests Scale

  In 13-14th gestational weeks

Other Outcomes (12)

• Decisional Conflict Scale

  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)

• SURE Scale

  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)

• Knowledge Form About Prenatal Genetic Diagnostic Tests

  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)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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.

Behavioral: Prenatal Genetic Counseling

Control

NO INTERVENTION

There was no intervention from the first antenatal visit in the control group. Routine clinical information was given about prenatal screening and diagnostic tests.

Interventions

Prenatal Genetic Counseling BEHAVIORAL

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.

Also known as: Counseling

Intervention

Eligibility Criteria

• Age: 19 Years - 46 Years
• Gender Eligibility Details: pregnant women was evaluated in this study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• taking first antenatal follow-up in 8-11. gestational weeks in where the study is conducted to have a single pregnancy
• to continue take the antenatal care in the hospital where the research was conducted
• at least primary school graduation,
• voluntary to participate the research.

You may not qualify if:

• want to exit from the study at her own request
• continue to antenatal follow-up in another hospital.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gulhane Tip Fakultesi: lead

Study Sites (2)

Health Science University

Ankara, 06010, Turkey (Türkiye)

Location

University Of Health Sciences

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 RESULT

MeSH Terms

Conditions

Chromosome Aberrations; Anxiety Disorders; Behavior

Interventions

Genetic Counseling; Counseling

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Genetic Services; Health Services; Health Care Facilities Workforce and Services; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services

Study Officials

• İlknur Yeşilçınar, PhD. RN.

  Health Science University

  STUDY DIRECTOR

• Gülten Güvenç, Assoc. Prof.

  Health Science University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. RN., Principal Investigator

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 1, 2019
• Study Start: June 10, 2017
• Primary Completion: March 5, 2018
• Study Completion: March 5, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)