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临床试验/NCT07545551
NCT07545551已完成不适用

THE EFFECT OF PERINATAL GRIEF COUNSELING PROVIDED VIA DIGITAL PLATFORM ON GRIEF AND POST-TRAUMATIC STRESS: A RANDOMIZED CONTROLLED STUDY

Gazi University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Change in grief levels

研究概览

简要总结

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.

详细描述

Perinatal loss is a significant life event that can lead to long-term psychological consequences, including prolonged grief, depression, and anxiety. Despite the high prevalence of these outcomes, access to structured psychological support remains limited, particularly in scalable and accessible formats.

This study investigates the effectiveness of a digitally delivered perinatal bereavement support program developed to provide structured emotional and psychological support for women following pregnancy loss. The intervention was administered over a five-week period and included components targeting grief processing, emotional expression, and adaptive coping strategies.

Participants were evaluated at multiple time points, including baseline (pre-intervention), post-intervention, and follow-up assessments at 1 month, 3 months, and 6 months. Psychological outcomes were assessed using validated measurement tools.

The primary aim of the study is to assess changes in psychological outcomes over time and to determine the sustainability of intervention effects during the follow-up period. This study contributes to the growing body of evidence supporting digital mental health interventions and offers insights into scalable support mechanisms for perinatal bereavement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

盲法说明

This is an open- label study with no masking

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • - 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Supportive Care (Behavioral)

control group

No Intervention

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

结局指标

主要结局

Change in grief levels

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

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Şengül Yaman Sözbir

Professor, Department of Obstetrics and Gynecology

Gazi University

研究点 (1)

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