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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorSakarya University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: "Psychosocial Support Intervention"Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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'.

Time frame
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
2

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.

Time frame
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
3

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.

Time frame
6 weeks after the birth

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sakarya University

Lead sponsor

The Scientific and Technological Research Council of Turkey

Collaborator