NCT07084103

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Sakarya University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Psychosocial Support Intervention	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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-09-30
• Completion: 2026-03-31
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: Turkey (Türkiye)