Individualized Grief Support With Swanson Model

NCT07333391 | Not Yet Recruiting

• 1 other identifier: SDUSuleyman
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pregnancy Loss; Grief

Keywords

Pregnancy Loss; Grief; İndividualized care; Swanson model; Psychosocial Support

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  3rd month

Study Arms (2)

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.

Other: Assigned Interventions

Interventions

Assigned Interventions OTHER

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.

intervention group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Women who have experienced pregnancy loss
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (1)

Suleyman Demirel University

Isparta, Merkez, 32200, Turkey (Türkiye)

Location

Related Links

• 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/s12905-0
• 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.
• 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.
• 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.
• 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.
• 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.
• Swanson KM. Effects of caring, measurement, and time on miscarriage impact and women's well-being. Nurs Res. 1999 Nov-Dec;48(6):288-98. doi: 10.1097/00006199-199911000-00004. PMID: 10571496.
• Zhuang S, Chen M, Ma X, Jiang J, Xiao G, Zhao Y, Hou J, Wang Y. The needs of women experiencing perinatal loss: A qualitative systematic review and meta-synthesis. Women Birth. 2023 Sep;36(5):409-420. doi: 10.1016/j.wombi.2023.03.007. Epub 2023 Apr 5. PM
• van den Berg MMJ, Dancet EAF, Erlikh T, van der Veen F, Goddijn M, Hajenius PJ. Patient-centered early pregnancy care: a systematic review of quantitative and qualitative studies on the perspectives of women and their partners. Hum Reprod Update. 2018 Ja

Study Officials

• Emel Taşçı Duran, Phd, RN

  Suleyman Demirel Üniversity

  STUDY DIRECTOR

Central Study Contacts

Fatma Pehlivan Msc, RN

CONTACT

+905068675172; fatmademirci@sdu.edu.tr

Emel Taşçı Duran Phd, RN

CONTACT

+905336434819; emelduran@sdu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized and assigned to intervention and control groups based on the calculated number in the study. The Research Randomizer website was used to assign participants to the sample for determining the intervention and control groups. Research Randomizer is a free resource for researchers who need a quick way to generate random numbers or assign participants to experimental conditions (https://randomizer.org/). A sample randomization for a sample of 48 participants is as follows. Intervention Group 2, 3, 4, 5, 8, 10, 12, 13, 14, 15, 16, 20, 22, 25, 27, 29, 30, 34, 35, 40, 41, 43, 46, 47 Control Group 1, 6,7, 9, 11, 17, 18, 19, 21, 23, 24, 26, 28, 31, 32, 33, 36, 37, 38, 39, 42, 44, 45, 48
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Nurse

Model Details: 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.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)