Perinatal LossDPBSPNCT07545551
Digital Perinatal Bereavement Support Program for Women After Pregnancy Loss
A study testing Supportive Care in people with Perinatal Loss and Grief, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Loss, Grief, Depression Anxiety Disorder
- What is being tested?
- Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Institute of Health Sciences
Ankara, Ankara, 06000
About this study
Official title: THE EFFECT OF PERINATAL GRIEF COUNSELING PROVIDED VIA DIGITAL PLATFORM ON GRIEF AND POST-TRAUMATIC STRESS: A RANDOMIZED CONTROLLED STUDY
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.
Read the detailed description
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.
- Conditions
- Perinatal Loss, Grief, Depression Anxiety Disorder
- Being tested
- Supportive Care
- Keywords
- perinatal beriavement, pregnancy loss, digital invertion, pylchological support, grief counseling, maternal mental health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Supportive Care |
| control group | No intervention | Participants received routine postpartum care without any additional structured supportive intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in grief levels
Change in grief levels measured using a validated grief scalesamong women experiencing perinatal loss, comparing the intervention and control groups.
Measured: Baseline, 5 weeks (end of inversions), and 1,3, and 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Apr 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal LossStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants received a structured digital perinatal bereavement support program over five weeks, with follow-up assessments conducted at 1, 3, and 6 months.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şengül Yaman Sözbir, Gazi University
- Investigators
- Şengül YAMAN SÖZBİR, PhD, Principal investigator, Gazi UniversityBüşra Özer, PhD Candidate, Study chair, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545551
- Sponsor's protocol ID
- 2025-1266
- Acronym
- DPBSP
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical restrictions and the sensitive nature of psychological data collected from participants experiencing perinatal loss. Data confidentiality and participant privacy will be strictly maintained in accordance with institutional review board (IRB) approvals and applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF PERINATAL GRIEF COUNSELING PROVIDED VIA DIGITAL PLATFORM ON GRIEF AND POST-TRAUMATIC STRESS: A RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT07545551
- Acronym / sponsor ID
- DPBSP / 2025-1266
- Conditions
- Perinatal Loss, Grief, Depression Anxiety Disorder
- Keywords
- perinatal beriavement, pregnancy loss, digital invertion, pylchological support, grief counseling, maternal mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants received a structured digital perinatal bereavement support program over five weeks, with follow-up assessments conducted at 1, 3, and 6 months.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Supportive CareParticipants 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. |
| control group | No intervention | –Participants received routine postpartum care without any additional structured supportive intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive CareA 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. | Behavioural | intervention group |
Primary outcome
Change in grief levels
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical restrictions and the sensitive nature of psychological data collected from participants experiencing perinatal loss. Data confidentiality and participant privacy will be strictly maintained in accordance with institutional review board (IRB) approvals and applicable regulations.
Related trials for Perinatal Loss
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Comparison of Social Media-Based and Online Training in Grief Counseling Education
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A Feasibility Randomised Control Trial to Evaluate Early Perinatal Bereavement Counselling for Parents Who Have Experienced a Perinatal Death
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Comprehensive Assessment of First Trimester Pregnancy Loss
Miscarriage in First Trimester
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şengül YAMAN SÖZBİR, PhD principal investigator
Gazi University
Büşra Özer, PhD Candidate study chair
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Care in people with Perinatal Loss and Grief, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in grief levels (time frame: Baseline, 5 weeks (end of inversions), and 1,3, and 6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.