Actively Recruiting
Effectiveness of a Psychosocial Support Intervention for Women Diagnosed With Fetal Anomaly: Randomised Controlled Trial
Led by Sakarya University · Updated on 2025-07-24
64
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Sakarya University
Lead Sponsor
T
The Scientific and Technological Research Council of Turkey
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a psychosocial support program for pregnant women diagnosed with fetal anomalies. The study uses a randomized controlled trial design to compare the outcomes of women receiving the support intervention with those receiving routine prenatal care. This research aims to help women cope with the challenges of a fetal anomaly diagnosis by improving their mental and physical health during pregnancy. Participants in the intervention group will receive a structured psychosocial support program that includes individual counseling sessions, stress management techniques, emotional support, and educational materials focused on coping strategies and mental well-being. This program is delivered by trained healthcare professionals during the prenatal period. The control group will receive usual prenatal care without additional psychosocial support. Throughout the study, researchers will assess participants' levels of depression, anxiety, stress, prenatal attachment, and maternal attachment. These will be measured before the 20th week of pregnancy, after a 6-week intervention, and during follow-up periods including 4 weeks after the post-test and 6 weeks after birth. This assessment helps evaluate the impact of the psychosocial support on emotional and maternal bonding outcomes.
CONDITIONS
Brief Title
Effectiveness of a Psychosocial Support Intervention for Women Diagnosed With Fetal Anomaly
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with a high risk of fetal abnormalities based on screening tests or ultrasound findings
- Decision to continue the current pregnancy
- Over 18 years of age
- Have received hospital services at least once after the initial diagnosis
- No mental or psychological disorders that make it difficult to express oneself
- Voluntary participation in the study
You will not qualify if you...
- Pregnant women who do not meet the inclusion criteria will be excluded from the study sample
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants in the intervention arm receive a structured psychosocial support program, including individual counseling sessions, stress management techniques, emotional support, and educational materials during pregnancy.
Sessions delivered online during prenatal period
Duration - Approximately 3 months
Participants are assessed for psychosocial outcomes 4 weeks after the intervention ends and again 6 weeks after birth.
2 visits (post-intervention and post-birth assessments)
Trial Site Locations
Total: 1 location
1
Sakarya University
Sakarya, Türkiye/Sakarya, Turkey (Türkiye), 54050
Actively Recruiting
Research Team
S
Semiha Ünkazan, Master of Licance
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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