Individualized Grief Support With Swanson Model

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness Web-based Training on Perinatal Loss

NCT06605274

Pregnancy Loss Psychological Distress Depression

COMPLETED NA

The Effect of Salutogenic Model-Based Care on Mothers of Children Suffering From Febrile Illness

NCT07265401

Mothers

COMPLETED NA

Transtheoretic Model, Postpartum Smoking Relapse, Smoking Cessation Intervention

NCT05711225

Postpartum Smoking Relapse

COMPLETED NA

Self-efficacy Scale for Mothers of Premature Babies

NCT05869019

Baby Care

UNKNOWN NA

Women's Health Behaviors Stages of Change (Transtheoretical Model) in Preconception Period

NCT03893084

Pregnancy Women Education

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy Loss Grief

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No intervention: Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention group

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.

Group Type EXPERIMENTAL

Assigned Interventions

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes