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Effectiveness of a Psychosocial Support Intervention for Women Diagnosed With Fetal Anomaly

Effectiveness of a Psychosocial Support Intervention for Women Diagnosed With Fetal Anomaly: Randomised Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07084103
Enrollment
64
Registered
2025-07-24
Start date
2025-04-01
Completion date
2026-03-31
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Abnormalities, Fetal Diseases, Mental Health, Pregnant Women, Psychosocial Support Systems

Keywords

Fetal anomaly, Congenital abnormalities, Psychosocial support, Psychological intervention, Pregnant women, Prenatal diagnosis, Mental health, Coping strategies, Emotional well-being

Brief 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. 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.

Interventions

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.

Sponsors

The Scientific and Technological Research Council of Turkey
CollaboratorOTHER
Sakarya University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

• Pregnant women who do not meet the inclusion criteria will be excluded from the sample.

Design outcomes

Primary

MeasureTime frameDescription
Level of depression, anxiety and stressPre-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 birthIt 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 attachmentPre-test data: before the 20th week of pregnancy Post-test data: after a 6-week intervention Follow-up data: 4 weeks after the post-testIt 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 attachment6 weeks after the birthThe 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactSemiha Ünkazan, Master of Licance
semihaunkazan@sakarya.edu.tr+905312052045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026