Fetal DiseasesNCT07084103
Effectiveness of a Psychosocial Support Intervention for Women Diagnosed With Fetal Anomaly
A study testing Psychosocial Support Intervention in people with Fetal Diseases and Congenital Abnormalities, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of a psychosocial support intervention for women diagnosed with fetal anomaly. A randomized controlled trial design will be used, and women diagnosed with fetal anomaly will be included as participants. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Diseases, Congenital Abnormalities, Pregnant Women
- What is being tested?
- Psychosocial Support Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In her current pregnancy, the results of the dual or triple screening test (a screening test result of 1:50 or 1:100 is considered a high risk for Down syndrome (Şirin, 2020) and/or ultrasound findings (physical/anatomical and congenital anomalies) indicate a high risk of foetal abnormalities,
- Decision to continue the pregnancy,
- Being over 18 years of age,
- Having received hospital services at least once after the initial diagnosis (this criterion was added to enable the pregnant woman to evaluate the services she received from the hospital after the diagnosis and to express her expectations beyond the services provided)
- No mental or psychological disorders that would make it difficult to express oneself,
- Voluntary participation in the study.
Who cannot join
- Pregnant women who do not meet the inclusion criteria will be excluded from the sample.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sakarya University
Sakarya, Türkiye/Sakarya, 54050
Sakarya University
About this study
Official title: Effectiveness of a Psychosocial Support Intervention for Women Diagnosed With Fetal Anomaly: Randomised Controlled Trial
This study aims to evaluate the effectiveness of a psychosocial support intervention for women diagnosed with fetal anomaly. A randomized controlled trial design will be used, and women diagnosed with fetal anomaly will be included as participants. The intervention group will receive a structured psychosocial support program, while the control group will receive routine care.
Read the detailed description
Providing psychosocial support to pregnant women to maintain their psychosocial health plays a facilitating role in helping them acquire the knowledge and skills necessary to cope with the difficulties they encounter, facilitating their functional adaptation and improving their quality of life. In the presence of a foetus with a diagnosis of anomaly risk during pregnancy, it becomes even more important for pregnant women to receive psychosocial support to protect their mental and physical health.
The main objective of this project is to examine the effectiveness of online psychosocial support provided to pregnant women with foetuses at risk of anomaly during their pregnancy. In line with this main objective, the psychosocial support needs of pregnant women with a risk of foetal abnormalities will first be determined using a qualitative research design. Subsequently, the effectiveness of the online psychosocial support developed in line with these needs will be objectively demonstrated in pregnant women with a risk of foetal abnormalities using a randomised controlled research design and measurement tools.
- Conditions
- Fetal Diseases, Congenital Abnormalities, Pregnant Women, Psychosocial Support Systems, Mental Health
- Being tested
- Psychosocial Support Intervention
- Keywords
- Fetal anomaly, Congenital abnormalities, Psychosocial support, Psychological intervention, Pregnant women, Prenatal diagnosis, Mental health, Coping strategies, Emotional well-being
- Medical subject headings
- Fetal Diseases, Congenital Abnormalities, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial Support InterventionBehavioural
Participants in the intervention arm will receive a structured psychosocial support program designed for women diagnosed with fetal anomaly. The program includes individual counseling sessions, stress management techniques, emotional support, and educational materials addressing coping strategies and mental well-being. The intervention will be delivered by trained healthcare professionals over sessions during the prenatal period.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants in the control arm will receive routine prenatal care as provided by their healthcare providers. No additional psychosocial support or structured intervention will be administered beyond the standard medical and obstetric services. |
| "Psychosocial Support Intervention" | Experimental | Participants in the intervention arm will receive a structured psychosocial support program designed for women diagnosed with fetal anomaly. The program includes individual counseling sessions, stress management techniques, emotional support, and educational materials addressing coping strategies and mental well-being. The intervention will be delivered by trained healthcare professionals over sessions during the prenatal period. Receives: Behavioral: Psychosocial Support Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of depression, anxiety and stress
It will be measured using the "Depression-Anxiety-Stress Scale". This scale is a 4-point Likert-type scale with responses ranging from '0 = never' to '3 = always' and consists of seven questions measuring 'depression, stress and anxiety dimensions'.
Measured: Pre-test data: before the 20th week of pregnancy Post-test data: after a 6-week intervention Follow-up data: 4 weeks after the post-test Second follow-up data: 6 weeks after the birth
Level of prenatal attachment
It will be measured using the "Prenatal Attachment Inventory". The scale, which consists of 21 items, was developed to describe the thoughts, feelings, and situations experienced by women during pregnancy and to determine their level of attachment to their baby during the prenatal period. Each item is scored on a four-point Likert scale ranging from 1 to 4. A score of at least 21 and a maximum of 84 can be obtained from the scale. An increase in the score obtained by the pregnant woman indicates an increase in the level of attachment. The items are scored as follows: 1: Never, 2: Sometimes, 3: Often, 4: Always.
Measured: Pre-test data: before the 20th week of pregnancy Post-test data: after a 6-week intervention Follow-up data: 4 weeks after the post-test
Level of maternal attachment
"The Maternal Attachment Scale" will be used to measure maternal attachment. Each item is a 26-item, four-point Likert-type scale ranging from 'always' to 'never.' Each item contains direct statements and is scored as follows: Always = 4, Often = 3, Sometimes = 2, and Never = 1. A total score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The lowest possible score from the scale is 26, and the highest is 104. A high score on the scale indicates a high level of maternal attachment.
Measured: 6 weeks after the birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Apr 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal DiseasesStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084103
- Sponsor's protocol ID
- E-16214662-050.01.04-305615
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Psychosocial Support Intervention for Women Diagnosed With Fetal Anomaly: Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07084103
- Acronym / sponsor ID
- E-16214662-050.01.04-305615
- Conditions
- Fetal Diseases, Congenital Abnormalities, Pregnant Women, Psychosocial Support Systems, Mental Health
- Keywords
- Fetal anomaly, Congenital abnormalities, Psychosocial support, Psychological intervention, Pregnant women, Prenatal diagnosis, Mental health, Coping strategies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 24 Jul 2025 (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.
This study aims to evaluate the effectiveness of a psychosocial support intervention for women diagnosed with fetal anomaly. A randomized controlled trial design will be used, and women diagnosed with fetal anomaly will be included as participants. The intervention group will receive a structured psychosocial support program, while the control group will receive routine care.
Detailed description
Providing psychosocial support to pregnant women to maintain their psychosocial health plays a facilitating role in helping them acquire the knowledge and skills necessary to cope with the difficulties they encounter, facilitating their functional adaptation and improving their quality of life. In the presence of a foetus with a diagnosis of anomaly risk during pregnancy, it becomes even more important for pregnant women to receive psychosocial support to protect their mental and physical health.
The main objective of this project is to examine the effectiveness of online psychosocial support provided to pregnant women with foetuses at risk of anomaly during their pregnancy. In line with this main objective, the psychosocial support needs of pregnant women with a risk of foetal abnormalities will first be determined using a qualitative research design. Subsequently, the effectiveness of the online psychosocial support developed in line with these needs will be objectively demonstrated in pregnant women with a risk of foetal abnormalities using a randomised controlled research design and measurement tools.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants in the control arm will receive routine prenatal care as provided by their healthcare providers. No additional psychosocial support or structured intervention will be administered beyond the standard medical and obstetric services. |
| "Psychosocial Support Intervention" | Experimental | Behavioral: Psychosocial Support InterventionParticipants in the intervention arm will receive a structured psychosocial support program designed for women diagnosed with fetal anomaly. The program includes individual counseling sessions, stress management techniques, emotional support, and educational materials addressing coping strategies and mental well-being. The intervention will be delivered by trained healthcare professionals over sessions during the prenatal period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- In her current pregnancy, the results of the dual or triple screening test (a screening test result of 1:50 or 1:100 is considered a high risk for Down syndrome (Şirin, 2020) and/or ultrasound findings (physical/anatomical and congenital anomalies) indicate a high risk of foetal abnormalities,
- Decision to continue the pregnancy,
- Being over 18 years of age,
- Having received hospital services at least once after the initial diagnosis (this criterion was added to enable the pregnant woman to evaluate the services she received from the hospital after the diagnosis and to express her expectations beyond the services provided)
- No mental or psychological disorders that would make it difficult to express oneself,
Key exclusion criteria (1 listed)
- Pregnant women who do not meet the inclusion criteria will be excluded from the sample.
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 |
|---|---|---|
| Psychosocial Support InterventionParticipants in the intervention arm will receive a structured psychosocial support program designed for women diagnosed with fetal anomaly. The program includes individual counseling sessions, stress management techniques, emotional support, and educational materials addressing coping strategies and mental well-being. The intervention will be delivered by trained healthcare professionals over sessions during the prenatal period. | Behavioural | "Psychosocial Support Intervention" |
Primary outcome
Level of depression, anxiety and stress
Time frame: Pre-test data: before the 20th week of pregnancy Post-test data: after a 6-week intervention Follow-up data: 4 weeks after the post-test Second follow-up data: 6 weeks after the birth
It will be measured using the "Depression-Anxiety-Stress Scale". This scale is a 4-point Likert-type scale with responses ranging from '0 = never' to '3 = always' and consists of seven questions measuring 'depression, stress and anxiety dimensions'.
Level of prenatal attachment
Time frame: Pre-test data: before the 20th week of pregnancy Post-test data: after a 6-week intervention Follow-up data: 4 weeks after the post-test
It will be measured using the "Prenatal Attachment Inventory". The scale, which consists of 21 items, was developed to describe the thoughts, feelings, and situations experienced by women during pregnancy and to determine their level of attachment to their baby during the prenatal period. Each item is scored on a four-point Likert scale ranging from 1 to 4. A score of at least 21 and a maximum of 84 can be obtained from the scale. An increase in the score obtained by the pregnant woman indicates an increase in the level of attachment. The items are scored as follows: 1: Never, 2: Sometimes, 3: Often, 4: Always.
Level of maternal attachment
Time frame: 6 weeks after the birth
"The Maternal Attachment Scale" will be used to measure maternal attachment. Each item is a 26-item, four-point Likert-type scale ranging from 'always' to 'never.' Each item contains direct statements and is scored as follows: Always = 4, Often = 3, Sometimes = 2, and Never = 1. A total score is obtained from the sum of all items. A high score indicates a high level of maternal attachment. The lowest possible score from the scale is 26, and the highest is 104. A high score on the scale indicates a high level of maternal attachment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial Support Intervention in people with Fetal Diseases and Congenital Abnormalities, run by Sakarya 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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Semiha Ünkazan, Master of Licance (+905312052045, semihaunkazan@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of depression, anxiety and stress (time frame: Pre-test data: before the 20th week of pregnancy Post-test data: after a 6-week intervention Follow-up data: 4 weeks after the post-test Second follow-up data: 6 weeks after the birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.