The Effect of Prenatal Genetic Counseling Service

NCT05508854 | Completed

• 1 other identifier: 485
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The research is planned as a randomized controlled experimental study in order to determine the effect of prenatal genetic counseling service on the anxiety levels and attitudes of pregnant women towards prenatal diagnostic tests and the relationship between these two parameters. Hypotheses of the Research: Three different sets of hypotheses were established for the research. First Hypothesis Set; H0: Prenatal genetic counseling service; It has no effect on the anxiety levels experienced by pregnant women. H1: Prenatal genetic counseling service; have an effect on the anxiety levels experienced by pregnant women. Second Hypothesis Set; H0: Prenatal genetic counseling service; It has no effect on the attitudes of pregnant women towards screening and diagnostic tests. H1: Prenatal genetic counseling service; It has an effect on the attitudes of pregnant women towards screening and diagnostic tests. Third Hypothesis Set; H0: There is no relationship between the anxiety experienced by pregnant women and their attitudes towards screening and diagnostic tests. H1: There is a relationship between the anxiety experienced by pregnant women and their attitudes towards screening and diagnostic tests.

Conditions

Anxiety; Attitude

Keywords

prenatal genetic counselling; pregnant; anxiety; attitude; nursing

Outcome Measures

Primary Outcomes (2)

• Spielberg State-Trait Anxiety Inventory (STAI I-II)

  The Spielberg state-trait anxiety inventory (STAI I-II) was developed by Spielberg et al. to determine the state and trait anxiety levels of individuals separately. STAI I and II are two separate scales, each consisting of 20 items, with a total of 40 questions. These two scales assess the individual's state and trait anxiety. The total score obtained from each scale can vary between 20 and 80. A large score indicates a high level of anxiety and a small score indicates a low level of anxiety. The Cronbach's alpha value was found to be between 0.83 and 0.87 for the state anxiety scale, and between 0.94 and 0.96 for the trait anxiety scale.

  Data collection form will be applied again before the counseling and when the pregnant woman comes to receive the genetic result (within about 2 weeks).

• Prenatal Screening and Diagnostic Test Attitude Assessment Scale

  It is a 4-question scale created by Martetau et al. to evaluate the thoughts of pregnant women about their participation in prenatal diagnosis and screening tests. In the original of the scale, the statements were evaluated over 7 points. It is a good idea (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 rate between 1 and 7 points. One point represents a negative attitude, while 7 points represents a highly positive attitude. . The highest score to be obtained from this scale is 28, and the lowest score is 4. The cronbach alpha value of the original scale was found to be 0.83.

  Data collection form will be applied again before the counseling and when the pregnant woman comes to receive the genetic result (within about 2 weeks).

Study Arms (2)

Experimental (counselling) group

EXPERIMENTAL

Experimental (counseling) group Prenatal genetic counseling is a consultancy service that covers the evaluation of the risk status of the baby in the mother's womb for diseases, the tests that can be done for the diagnosis of the disease, test results and presentation.A data collection form will be applied to all pregnant women between the ages of 18-49 who applied to the medical genetics polyclinic between September and November 2022 and wished to participate in the study. Prenatal genetic counseling will then be given. When it comes to obtaining genetic results, an individual interview will be made with the pregnant woman and the data collection form will be applied again. In the study, routine clinical information will be given to the pregnant women in the control group by the physician. Before the clinical information and when they come to get genetic results, the data collection form will be applied again by making an individual interview with the pregnant woman.

Genetic: prenatal genetic counselling

Control group

NO INTERVENTION

In the study, routine clinical information will be given to the pregnant women in the control group by the physician. Before the clinical information and when they come to get genetic results, the data collection form will be applied again by making an individual interview with the pregnant woman.

Interventions

prenatal genetic counselling GENETIC

Prenatal genetic counseling is a consultancy service that covers the evaluation of the risk status of the baby in the mother's womb in terms of genetic diseases, the tests and risks that can be done for the diagnosis of the disease, the test results and information about the disease in case of illness and the presentation of options.

Experimental (counselling) group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Willing to participate in the research,
• Between the ages of 18-49
• Able to read and write Turkish,
• Open to communication,
• First prenatal care at 8-11. taking at the gestational week,
• Having a singleton pregnancy,
• Prenatal check-ups will be carried out at the hospital where the research will be conducted,
• At least primary school graduate,

You may not qualify if:

• \- Those who do not agree to participate in the research,
• Can't read or write Turkish,
• Unable to communicate
• Pregnant women who continue their antenatal follow-ups in another hospital.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Cukurova University

Adana, Sarıcam, 01250, Turkey (Türkiye)

Location

Related Publications (1)

• Yesilcinar I, Seven M, Pasalak SI, Guvenc G. Interventions aiming to improve informed decision on prenatal screening and testing: A scoping review of the literature. J Genet Couns. 2021 Dec;30(6):1512-1521. doi: 10.1002/jgc4.1437. Epub 2021 Jun 17.

  PMID: 34137487 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Behavior

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Parallel Assignment Prospective, parallel, two arm, randomized controlled clinical trial

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 19, 2022
• Study Start: September 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: July 10, 2023
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)