Digital Perinatal Bereavement Support Program for Women After Pregnancy Loss

NCT07545551 | Completed

• 1 other identifier: 2025-1266
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of a digital perinatal bereavement support program designed for women who have experienced pregnancy loss. Perinatal loss is associated with significant psychological distress, including grief, depression, and anxiety, which may persist over time if not adequately addressed. The intervention consists of a structured digital support program delivered over five weeks, focusing on emotional processing, coping strategies, and psychological resilience. Participants were assessed at baseline, immediately after the intervention, and during follow-up periods at 1 month, 3 months, and 6 months. The primary objective is to determine whether the intervention improves psychological outcomes, including grief and depressive symptoms. The findings are expected to contribute to the development of accessible and scalable mental health support models for women experiencing perinatal loss.

Conditions

Grief; Perinatal Loss; Depression Anxiety Disorder

Keywords

perinatal beriavement; pregnancy loss; digital invertion; pylchological support; grief counseling; maternal mental health

Outcome Measures

Primary Outcomes (1)

• Change in grief levels

  Change in grief levels measured using a validated grief scalesamong women experiencing perinatal loss, comparing the intervention and control groups.

  Baseline, 5 weeks (end of inversions), and 1,3, and 6 months follow up

Study Arms (2)

intervention group

EXPERIMENTAL

Participants received a structured supportive care program following perinatal loss. The intervention was delivered over a 5-week period and included psychological support aimed at reducing grief, anxiety, and depression.

Behavioral: Supportive Care

control group

NO INTERVENTION

Participants received routine postpartum care without any additional structured supportive intervention.

Interventions

Supportive Care BEHAVIORAL

A structured supportive care program designed for women experiencing perinatal loss. The intervention was delivered over 5 weeks through a digital platform specifically developed for this study. It included regular psychological support sessions aimed at reducing grief, anxiety, and depressive symptoms. The program incorporated emotional support, coping strategies, and guided communication techniques.

intervention group

Eligibility Criteria

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

You may qualify if:

• \- Women aged 18 years and older who have experienced perinatal loss within the past two months; ability to read and write at a basic level; ability to speak and understand Turkish; access to a digital platform (internet-enabled device); and no history of previous live birth. Provision of informed consent.

You may not qualify if:

• History of a previous perinatal loss; presence of any uncontrolled psychiatric disorder; presence of communication impairments (cognitive, auditory, or visual); experiencing another major grief event (e.g., divorce, death) within the past year; or receiving any psychosocial support within the past year.

Sponsors & Collaborators

• Gazi University: lead
• Gazi University Scientific Research Projects Unit (BAP) Project No: TDK-2026-10810: collaborator

Study Sites (1)

Gazi University Institute of Health Sciences

Ankara, Ankara, 06000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Palliative Care

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Şengül YAMAN SÖZBİR, PhD

  Gazi University

  PRINCIPAL INVESTIGATOR

• Büşra Özer, PhD Candidate

  Gazi University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open- label study with no masking
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Obstetrics and Gynecology

Model Details: Participants received a structured digital perinatal bereavement support program over five weeks, with follow-up assessments conducted at 1, 3, and 6 months.

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)