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

NCT ID: NCT07084103

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

"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.

Group Type: EXPERIMENTAL

Psychosocial Support Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sakarya University

Sakarya, Türkiye/Sakarya, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Semiha Ünkazan, Master of Licance

Role: CONTACT

semihaunkazan@sakarya.edu.tr

+905312052045

Facility Contacts

Sakarya University

Role: primary

Other Identifiers

E-16214662-050.01.04-305615

Identifier Type: -

Identifier Source: org_study_id