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NCT Number: NCT07333391

Individualized Grief Support With Swanson Model

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emel Taşçı Duran Phd, RN

CONTACT

[email protected]

+905336434819

Fatma Pehlivan Msc, RN

CONTACT

[email protected]

+905068675172

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Official study title

Evaluation of the Effectiveness of Individualized Grief Support Based on the Swanson Caring Model in Women Experiencing Pregnancy Loss

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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