Clinical trial NCT05508854: The Effect of Prenatal Genetic Counseling Service
Official title: The Effect of Prenatal Genetic Counseling Service on the anxıety Levels of Pregnancy and the Attitudes of Prenatal Diagnostic Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Attitude
Keywords: prenatal genetic counselling
pregnant
anxiety
attitude
nursing
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Prospective, parallel, two arm, randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Spielberg State-Trait Anxiety Inventory (STAI I-II)
timeFrame: 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).
measure: Prenatal Screening and Diagnostic Test Attitude Assessment Scale
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Sarıcam
Study officials:
References:
citation: 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.