Evaluation of the Effectiveness of Individualized Grief Support Based on the Swanson Caring Model in Women Experiencing Pregnancy Loss
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Personal Information Form (Pre-Test)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
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.
干预措施: Assigned Interventions (Other)
结局指标
主要结局
Personal Information Form (Pre-Test)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Fatma Pehlivan
Clinical Research Nurse
Suleyman Demirel University
