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

NCT07084103 | Recruiting

• 1 other identifier: E-16214662-050.01.04-305615
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

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; Emotional well-being

Outcome Measures

Primary Outcomes (3)

• 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'.

  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.

  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.

  6 weeks after the birth

Study Arms (2)

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.

Behavioral: Psychosocial Support Intervention

Interventions

Psychosocial Support Intervention 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.

"Psychosocial Support Intervention"

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Sakarya University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Sakarya University

Sakarya, Türkiye/Sakarya, 54050, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fetal Diseases; Congenital Abnormalities; Psychological Well-Being

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Personal Satisfaction; Behavior

Central Study Contacts

Semiha Ünkazan, Master of Licance

CONTACT

+905312052045; semihaunkazan@sakarya.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 24, 2025
• Study Start: April 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: March 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)