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Not yet recruiting NCT07333391

Individualized Grief Support With Swanson Model

No phase Interventional Pregnancy Loss Grief

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assigned Interventions.
Who it may be relevant to
Registry conditions: Pregnancy Loss, Grief. Basic parameters: 18 years — 50 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Assigned Interventions
    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 outcome measures

  • Personal Information Form (Pre-Test) [Time frame: At baseline (prior to intervention)]
  • Sociodemographic Characteristics Form [Time frame: Baseline (pre-intervention)]
  • Perinatal Grief Scale (PGS) Score [Time frame: Baseline (pre-intervention)]
  • Depression Anxiety Stress Scale-21 (DASS-21) [Time frame: Baseline (pre-intervention)]
  • Bereavement Brochure [Time frame: Immediately post-intervention]
  • Semi-Structured Interview [Time frame: 1 week]
  • Swanson-Based Grief Counseling (First Session) [Time frame: 3 weeks]
  • Swanson-Based Bereavement Counseling (Second Session) [Time frame: 2nd month]
  • Swanson-Based Bereavement Counseling (Third Session) + Post-Test Data Collection [Time frame: 3rd month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Turkey (Türkiye) · 1 center
  • Suleyman Demirel University — Isparta

Identifiers

NCT: NCT07333391 · SDUSuleyman

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗