Anxiety Clinical Trial
Official title:
The Effect of Prenatal Genetic Counseling Service on the anxıety Levels of Pregnancy and the Attitudes of Prenatal Diagnostic Tests
NCT number | NCT05508854 |
Other study ID # | 485 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2022 |
Est. completion date | July 10, 2023 |
Verified date | September 2023 |
Source | Mersin University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | July 10, 2023 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Cukurova University | Adana | Saricam |
Lead Sponsor | Collaborator |
---|---|
Mersin University |
Turkey,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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). | |
Primary | 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). |
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