AnxietyNCT05508854
The Effect of Prenatal Genetic Counseling Service
A study testing prenatal genetic counselling in people with Anxiety and Attitude, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- What is being tested?
- prenatal genetic counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 10 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Prenatal Genetic Counseling Service on the anxıety Levels of Pregnancy and the Attitudes of Prenatal Diagnostic Tests
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:
Read more
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.
Read the 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.
- Being tested
- prenatal genetic counselling
- Keywords
- prenatal genetic counselling, pregnant, anxiety, attitude, nursing
- Medical subject headings
- Anxiety Disorders, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prenatal genetic counsellingGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Sep 2022
- Primary completion30 Dec 2022
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Prospective, parallel, two arm, randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiler ÇOKAN DÖNMEZ, Phd, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508854
- Sponsor's protocol ID
- 485
- Status last verified
- Sep 2023
- First submitted
- 18 Aug 2022
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34137487
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prenatal Genetic Counseling Service on the anxıety Levels of Pregnancy and the Attitudes of Prenatal Diagnostic Tests
- ClinicalTrials.gov ID
- NCT05508854
- Acronym / sponsor ID
- 485
- Keywords
- prenatal genetic counselling, pregnant, anxiety, attitude, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment Prospective, parallel, two arm, randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental (counselling) group | Experimental | Genetic: prenatal genetic counsellingExperimental (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. |
| 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Willing to participate in the research,
Key exclusion criteria (4 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prenatal genetic counsellingPrenatal 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. | Genetic | Experimental (counselling) group |
Primary outcome
Spielberg State-Trait Anxiety Inventory (STAI I-II)
Time frame: 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).
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.
Prenatal Screening and Diagnostic Test Attitude Assessment Scale
Time frame: 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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Background: PubMed 34137487Yesilcinar 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.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prenatal genetic counselling in people with Anxiety and Attitude, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spielberg State-Trait Anxiety Inventory (STAI I-II) (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.