Ireland
--:--IST
Recruiting Not applicable

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

NCT07084103 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-04-01
Last updated
2025-07-24

Condition(s) studied

Fetal DiseasesCongenital AbnormalitiesPregnant WomenPsychosocial Support SystemsMental Health

Investigational drug(s) / intervention(s)

Psychosocial Support Intervention

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • Level of depression, anxiety and stress — 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
    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'.
  • Level of prenatal attachment — 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
    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.
  • Level of maternal attachment — 6 weeks after the birth
    "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.

Trial sites (1)

FacilityCityRegionStatus
Sakarya University Sakarya Türkiye/Sakarya Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07084103 on ClinicalTrials.gov ↗ ← All trials in Turkey