Pregnancy LossNCT07333391
Individualized Grief Support With Swanson Model
A study testing Assigned Interventions in people with Pregnancy Loss and Grief, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to examine the effects of individualized grief support for women experiencing pregnancy loss. The research, which will be conducted at Süleyman Demirel University, is a mixed-method design and includes both phenomenological qualitative analysis and randomized controlled quantitative trials. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Loss, Grief
- What is being tested?
- Assigned Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 years and above,
- Literate,
- Able to understand and speak Turkish,
- Desired and planned pregnancies
- No diagnosed psychiatric illness,
- No hearing or mental disabilit
Who cannot join
- Women who experienced pregnancy loss after infertility treatment
- Women who received psychological support during the process
- Women who scored very high on the DAS scale
- Women who withdrew from the study at any stage
- Women who did not complete the data collection forms will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Suleyman Demirel University
Isparta, Merkez, 32200
Fatma Pehlivan Msc, RN, +905968675172, fatmademirci@sdu.edu.tr
Emel Taşçı Duran Phd, RN, +905336434819, emelduran@sdu.edu.tr
About this study
Official title: Evaluation of the Effectiveness of Individualized Grief Support Based on the Swanson Caring Model in Women Experiencing Pregnancy Loss
This study aims to examine the effects of individualized grief support for women experiencing pregnancy loss. The research, which will be conducted at Süleyman Demirel University, is a mixed-method design and includes both phenomenological qualitative analysis and randomized controlled quantitative trials. The sample will include 48 women; those with severe depression will be excluded. Quantitative data will be analyzed using SPSS, and qualitative data will be analyzed using content analysis.
Read the detailed description
Pregnancy loss is a traumatic experience that leaves deep marks on women's lives. The grieving process that women experience during this period varies according to individual differences. The aim of this study is to examine the effects of individualized grief support for women who have experienced pregnancy loss. By addressing the emotional and psychological challenges women face after pregnancy loss, the study seeks to explore how the most appropriate support and care can be provided.
The sample of the study will consist of women who have experienced pregnancy loss at Süleyman Demirel University Research and Training Hospital, Department of Obstetrics and Gynecology. The power analysis of the study was conducted using the GPower 3.1.9.6 (Franz Faul, Universitaet Kiel, Germany) program, and the sample size was calculated as n=24+24=48. Women who obtain a very high score (14+) on the depression subscale of the Depression-Anxiety-Stress Scale will not be included in the study due to pathological findings.
This research will be conducted as a mixed-method study incorporating both qualitative and quantitative methods. In the qualitative part of the study, a phenomenological design, which is suitable for the nature of the research, will be used. The quantitative part will be conducted as a randomized controlled trial. Quantitative data are planned to be analyzed using the SPSS (Statistical Program for Social Sciences) 26.0 statistical analysis package. Qualitative data will be analyzed through content analysis using a software program commonly utilized for qualitative research.
- Conditions
- Pregnancy Loss, Grief
- Being tested
- Assigned Interventions
- Keywords
- Pregnancy Loss, Grief, İndividualized care, Swanson model, Psychosocial Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsOther
Semi-structured interviews will be conducted with women who have experienced pregnancy loss, and their experiences and grieving processes will be examined phenomenologically. In the 3rd, 4th, and 5th interviews, based on the findings obtained from the qualitative data, grief counseling based on the Swanson care model will be provided to the women, and they will be provided with nursing care and grief support.
| Study group | Role | What they receive |
|---|---|---|
| No intervention: Control Group | No intervention | Women assigned to the control group will be administered the Personal Information Form and pretests (PGS, DAS-21) at the first interview. Nurses will instruct the women on the hospital's routine procedures. No intervention will be administered. A posttest (PGS, DAS-21) will be administered three months after the loss. |
| intervention group | Experimental | Women in the intervention group will complete a Personal Information Form and baseline measures (PGS, DAS-21) during the first hospital-based interview, where they will also receive an expert-informed grief brochure. One week after pregnancy loss, a second interview involving a semi-structured, phenomenological exploration of their grief experiences will be conducted. The 3rd, 4th, and 5th interviews-held three weeks after the second interview, in the second month, and in the third month-will focus on providing grief counseling and nursing care based on the Swanson care model. In the final interview, post-test measures (PGS, DAS-21) will be administered. Receives: Other: Assigned Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form (Pre-Test)
This form will be administered to women during the initial interview after they are accepted into the service.
It was developed by researchers to determine sociodemographic characteristics such as age, marital status, pregnancy history, and educational background. Women will also undergo pre-tests (PGS and DASS-21) during the initial interview.
Measured: At baseline (prior to intervention)
Sociodemographic Characteristics Form
This form assesses participants' sociodemographic and obstetric characteristics, including age, marital status, educational level, and pregnancy history. The form is administered by the researcher during the initial interview after participants are accepted into the service.
Measured: Baseline (pre-intervention)
Perinatal Grief Scale (PGS) Score
The Perinatal Grief Scale (PGS) is a self-report instrument used to assess grief intensity following pregnancy loss. The scale consists of 33 items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 33 to 165, with higher scores indicating greater levels of perinatal grief.
Measured: Baseline (pre-intervention)
Depression Anxiety Stress Scale-21 (DASS-21)
The Depression Anxiety Stress Scale-21 (DASS-21) is a self-report instrument used to assess symptoms of depression, anxiety, and stress. The scale consists of 21 items rated on a 4-point Likert scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). The scale includes three subscales-Depression, Anxiety, and Stress-each comprising 7 items. Subscale scores are calculated by summing the relevant items and multiplying by two. Higher scores indicate greater symptom severity.
Severity Classification:
DASS-21 subscale scores are categorized as follows:
Severity Level Depression Anxiety Stress Normal 0-4 0-3 0-7 Mild 5-6 4-5 8-9 Moderate 7-10 6-7 10-12 Severe 11-13 8-9 13-16 Extremely Severe ≥14 ≥10 ≥17
Measured: Baseline (pre-intervention)
Bereavement Brochure
A bereavement brochure, prepared with the contribution of experts, will be provided to women following pregnancy loss during the initial interview. The brochure contains information about emotional reactions, coping strategies, and available support resources.
Measured: Immediately post-intervention
Semi-Structured Interview
One week after the initial interview, semi-structured interviews will be conducted with women who have experienced pregnancy loss. In this interview, grief experiences and needs will be examined phenomenologically.
Measured: 1 week
Swanson-Based Grief Counseling (First Session)
In the third interview, grief counseling will be provided based on findings from qualitative data. The counseling process will be structured using the Swanson Care Model.
Measured: 3 weeks
Swanson-Based Bereavement Counseling (Second Session)
In the fourth interview, bereavement counseling will again be conducted based on the Swanson Model, tailored to the woman's ongoing needs and responses.
Measured: 2nd month
Swanson-Based Bereavement Counseling (Third Session) + Post-Test Data Collection
During the fifth interview, bereavement counseling will continue based on the Swanson Model. At this stage, post-test data collection forms (PGS and DASS-21) will also be administered.
Measured: 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy LossStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research will be conducted as a mixed methods study involving both qualitative and quantitative methods. The qualitative part of the study will utilize a phenomenological design appropriate to the nature of the study, as part of a qualitative research design. The quantitative part of the study will be conducted as a randomized controlled trial. The sample consisted of 48 individuals who experienced pregnancy loss, agreed to participate in the study voluntarily, and met the inclusion criteria.Data will be collected using a Personal Information Form containing descriptive information about the women, the Perinatal Grief Scale (33-item short version), the Depression Anxiety Stress Scale-21 (DAS-21), and a semi-structured "Interview Form" based on the Swanson Model of Care.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Pehlivan, Suleyman Demirel University
- Investigators
- Emel Taşçı Duran, Phd, RN, Study director, Suleyman Demirel Üniversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333391
- Sponsor's protocol ID
- SDUSuleyman
- Status last verified
- Dec 2025
- First submitted
- 24 Nov 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Individualized Grief Support Based on the Swanson Caring Model in Women Experiencing Pregnancy Loss
- ClinicalTrials.gov ID
- NCT07333391
- Acronym / sponsor ID
- SDUSuleyman
- Conditions
- Pregnancy Loss, Grief
- Keywords
- Pregnancy Loss, Grief, İndividualized care, Swanson model, Psychosocial Support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 12 Jan 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 examine the effects of individualized grief support for women experiencing pregnancy loss. The research, which will be conducted at Süleyman Demirel University, is a mixed-method design and includes both phenomenological qualitative analysis and randomized controlled quantitative trials. The sample will include 48 women; those with severe depression will be excluded. Quantitative data will be analyzed using SPSS, and qualitative data will be analyzed using content analysis.
Detailed description
Pregnancy loss is a traumatic experience that leaves deep marks on women's lives. The grieving process that women experience during this period varies according to individual differences. The aim of this study is to examine the effects of individualized grief support for women who have experienced pregnancy loss. By addressing the emotional and psychological challenges women face after pregnancy loss, the study seeks to explore how the most appropriate support and care can be provided.
The sample of the study will consist of women who have experienced pregnancy loss at Süleyman Demirel University Research and Training Hospital, Department of Obstetrics and Gynecology. The power analysis of the study was conducted using the GPower 3.1.9.6 (Franz Faul, Universitaet Kiel, Germany) program, and the sample size was calculated as n=24+24=48. Women who obtain a very high score (14+) on the depression subscale of the Depression-Anxiety-Stress Scale will not be included in the study due to pathological findings.
This research will be conducted as a mixed-method study incorporating both qualitative and quantitative methods. In the qualitative part of the study, a phenomenological design, which is suitable for the nature of the research, will be used. The quantitative part will be conducted as a randomized controlled trial. Quantitative data are planned to be analyzed using the SPSS (Statistical Program for Social Sciences) 26.0 statistical analysis package. Qualitative data will be analyzed through content analysis using a software program commonly utilized for qualitative research.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This research will be conducted as a mixed methods study involving both qualitative and quantitative methods. The qualitative part of the study will utilize a phenomenological design appropriate to the nature of the study, as part of a qualitative research design. The quantitative part of the study will be conducted as a randomized controlled trial. The sample consisted of 48 individuals who experienced pregnancy loss, agreed to participate in the study voluntarily, and met the inclusion criteria.Data will be collected using a Personal Information Form containing descriptive information about the women, the Perinatal Grief Scale (33-item short version), the Depression Anxiety Stress Scale-21 (DAS-21), and a semi-structured "Interview Form" based on the Swanson Model of Care.
| Arm | Type | Receives |
|---|---|---|
| No intervention: Control Group | No intervention | –Women assigned to the control group will be administered the Personal Information Form and pretests (PGS, DAS-21) at the first interview. Nurses will instruct the women on the hospital's routine procedures. No intervention will be administered. A posttest (PGS, DAS-21) will be administered three months after the loss. |
| intervention group | Experimental | Other: Assigned InterventionsWomen in the intervention group will complete a Personal Information Form and baseline measures (PGS, DAS-21) during the first hospital-based interview, where they will also receive an expert-informed grief brochure. One week after pregnancy loss, a second interview involving a semi-structured, phenomenological exploration of their grief experiences will be conducted. The 3rd, 4th, and 5th interviews-held three weeks after the second interview, in the second month, and in the third month-will focus on providing grief counseling and nursing care based on the Swanson care model. In the final interview, post-test measures (PGS, DAS-21) will be administered. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 18 years and above,
- Literate,
- Able to understand and speak Turkish,
- Desired and planned pregnancies
- No diagnosed psychiatric illness,
Key exclusion criteria (5 listed)
- Women who experienced pregnancy loss after infertility treatment
- Women who received psychological support during the process
- Women who scored very high on the DAS scale
- Women who withdrew from the study at any stage
- Women who did not complete the data collection forms will be excluded from the study.
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 |
|---|---|---|
| Assigned InterventionsSemi-structured interviews will be conducted with women who have experienced pregnancy loss, and their experiences and grieving processes will be examined phenomenologically. In the 3rd, 4th, and 5th interviews, based on the findings obtained from the qualitative data, grief counseling based on the Swanson care model will be provided to the women, and they will be provided with nursing care and grief support. | Other | intervention group |
Primary outcome
Personal Information Form (Pre-Test)
Time frame: At baseline (prior to intervention)
This form will be administered to women during the initial interview after they are accepted into the service. It was developed by researchers to determine sociodemographic characteristics such as age, marital status, pregnancy history, and educational background. Women will also undergo pre-tests (PGS and DASS-21) during the initial interview.
Sociodemographic Characteristics Form
Time frame: Baseline (pre-intervention)
This form assesses participants' sociodemographic and obstetric characteristics, including age, marital status, educational level, and pregnancy history. The form is administered by the researcher during the initial interview after participants are accepted into the service.
Perinatal Grief Scale (PGS) Score
Time frame: Baseline (pre-intervention)
The Perinatal Grief Scale (PGS) is a self-report instrument used to assess grief intensity following pregnancy loss. The scale consists of 33 items rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 33 to 165, with higher scores indicating greater levels of perinatal grief.
Depression Anxiety Stress Scale-21 (DASS-21)
Time frame: Baseline (pre-intervention)
The Depression Anxiety Stress Scale-21 (DASS-21) is a self-report instrument used to assess symptoms of depression, anxiety, and stress. The scale consists of 21 items rated on a 4-point Likert scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time). The scale includes three subscales-Depression, Anxiety, and Stress-each comprising 7 items. Subscale scores are calculated by summing the relevant items and multiplying by two. Higher scores indicate greater symptom severity. Severity Classification: DASS-21 subscale scores are categorized as follows: Severity Level Depression Anxiety Stress Normal 0-4 0-3 0-7 Mild 5-6 4-5 8-9 Moderate 7-10 6-7 10-12 Severe 11-13 8-9 13-16 Extremely Severe ≥14 ≥10 ≥17
Bereavement Brochure
Time frame: Immediately post-intervention
A bereavement brochure, prepared with the contribution of experts, will be provided to women following pregnancy loss during the initial interview. The brochure contains information about emotional reactions, coping strategies, and available support resources.
Semi-Structured Interview
Time frame: 1 week
One week after the initial interview, semi-structured interviews will be conducted with women who have experienced pregnancy loss. In this interview, grief experiences and needs will be examined phenomenologically.
Swanson-Based Grief Counseling (First Session)
Time frame: 3 weeks
In the third interview, grief counseling will be provided based on findings from qualitative data. The counseling process will be structured using the Swanson Care Model.
Swanson-Based Bereavement Counseling (Second Session)
Time frame: 2nd month
In the fourth interview, bereavement counseling will again be conducted based on the Swanson Model, tailored to the woman's ongoing needs and responses.
Swanson-Based Bereavement Counseling (Third Session) + Post-Test Data Collection
Time frame: 3rd month
During the fifth interview, bereavement counseling will continue based on the Swanson Model. At this stage, post-test data collection forms (PGS and DASS-21) will also be administered.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Bellhouse C, Temple-Smith MJ, Bilardi JE. "It's just one of those things people don't seem to talk about..." women's experiences of social support following miscarriage: a qualitative study. BMC Womens Health. 2018 Oct 29;18(1):176. doi: 10.1186/s12905-0Link provided by the sponsor.
- Hutti MH. Social and professional support needs of families after perinatal loss. J Obstet Gynecol Neonatal Nurs. 2005 Sep-Oct;34(5):630-8. doi: 10.1177/0884217505279998. PMID: 16227519.Link provided by the sponsor.
- Koert E, Hartwig TS, Hviid Malling GM, Schmidt L, Nielsen HS. 'You're never pregnant in the same way again': prior early pregnancy loss influences need for health care and support in subsequent pregnancy. Hum Reprod Open. 2023 Aug 1;2023(3):hoad032.Link provided by the sponsor.
- Lidegaard Ø, Mikkelsen AP, Egerup P, Kolte AM, Rasmussen SC, Nielsen HS. Pregnancy loss: A 40-year nationwide assessment. Acta Obstet Gynecol Scand. 2020 Nov;99(11):1492-1496. doi: 10.1111/aogs.13860. Epub 2020 Apr 26. PMID: 32255196.Link provided by the sponsor.
- McSpedden M, Mullan B, Sharpe L, Breen LJ, Lobb EA. The presence and predictors of complicated grief symptoms in perinatally bereaved mothers from a bereavement support organization. Death Stud. 2017 Feb;41(2):112-117. doi: 10.1080/07481187.2016.1210696.Link provided by the sponsor.
- Smith LK, Dickens J, Bender Atik R, Bevan C, Fisher J, Hinton L. Parents' experiences of care following the loss of a baby at the margins between miscarriage, stillbirth and neonatal death: a UK qualitative study. BJOG. 2020 Jun;127(7):868-874.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Emel Taşçı Duran, Phd, RN study director
Suleyman Demirel Üniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions in people with Pregnancy Loss and Grief, run by Suleyman Demirel 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Pehlivan Msc, RN (+905068675172, fatmademirci@sdu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (Pre-Test) (time frame: At baseline (prior to intervention)). The study lists 9 primary outcomes in all. 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 12 Jan 2026.