The Effect of Prenatal Genetic Counseling Service

NCT ID: NCT05508854

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-07-10

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.

Detailed Description

In the study, it was aimed to determine the relationship between the effect of prenatal genetic counseling service on the anxiety levels of pregnant women and their attitudes towards prenatal diagnostic tests, and the anxiety levels of pregnant women and their attitudes towards prenatal diagnostic tests.

Pregnant women who applied to Adana City Hospital Medical Genetics Outpatient Clinic for prenatal diagnosis and met the research criteria and volunteered to participate in the study will be randomly assigned to the study and control groups according to the block randomization method in order to eliminate the selection bias according to the outpatient clinic list and to ensure the balance in the number of individuals between the groups.

In the study, there will be two groups, the study and the control, selected by randomization. Pregnant women who meet the research criteria will be informed about the research in the Medical Genetics outpatient clinic. Informed (voluntary) consent forms will be signed by the pregnant women who accept to participate in the study.

A data collection form will be applied to all pregnant women participating in the study. Before prenatal genetic counseling is given to the pregnant women in the study group, a data collection form will be applied. Prenatal genetic counseling will then be given. In this consultancy, after giving information about what the diagnostic tests are and their purpose, specific consultancy will be given to the proposed invasive test. When she comes to get genetic results, the data collection form will be applied again by making an individual interview with the pregnant woman. The result of the diagnosis test of the pregnant and the decision to continue or terminate the pregnancy will be recorded in the data collection form. Families who are diagnosed with a disease that threatens the life of the fetus or is incompatible with life will be counseled to receive perinatal palliative care. During this period, they will be guided to communicate with health professionals who can get support and they will be supported to make applications for their spiritual needs. In all these stages, care will be provided to the pregnant with a multidisciplinary approach.

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.

Conditions

Anxiety; Attitude

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Experimental (counselling) group

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.

Group Type: EXPERIMENTAL

prenatal genetic counselling

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

prenatal genetic counselling

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.

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• 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,

Exclusion Criteria

• - 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: lead

Responsible Party

Çiler ÇOKAN DÖNMEZ, Phd

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cukurova University

Adana, Sarıcam, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 34137487 (View on PubMed)

Other Identifiers

485

Identifier Type: -

Identifier Source: org_study_id