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临床试验/NCT06590376
NCT06590376已完成不适用

The Effect of Midwifery Care Based on Swanson Care Theory Given to Couples Experiencing Pregnancy Loss on the Level of Grief and General Well-Being

Istanbul University - Cerrahpasa (IUC)2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
76
试验地点
2
主要终点
perinatal grief level

研究概览

简要总结

This study was designed as a randomised controlled, 2-group, pre-test-post-test comparative, experimental study to increase the general well-being of women experiencing pregnancy loss and to decrease the level of perinatal grief.

详细描述

Objective

The aim of this study was to examine the effect of midwifery care and counselling based on Swanson Care Theory for couples experiencing pregnancy loss on womens perinatal grief and general well-being levels.

Method: The study had an experimental two-group pretest-posttest design. Midwifery care and counselling based on Swanson Care Theory is a grief support program consisting of eight interviews, including four face-to-face interviews after the woman's admission to the clinic and four telephone interviews until the 30th day after discharge. The study was conducted with 76 couples admitted to the obstetrics and gynecology department of a training and research hospital in Istanbul between August 2023 and May 2024 with a diagnosis of pregnancy loss. The intervention group (n=38) received midwifery care and counselling based on Swanson Care Theory in addition to routine midwifery care in accordance with clinical procedures, whereas the control group (n=38) received only routine midwifery care in accordance with clinical procedures. This study used the Women Experiencing Pregnancy Loss Introductory Information Form, Men Experiencing Pregnancy Loss Introductory Information Form, Perinatal Bereavement Scale, and General Well-Being Scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

The numbers from 1 to 96 were randomly allocated into two groups on the random.org website and randomly selected numbers were assigned to the intervention and control groups. This process ensured that the participants were equally and randomly distributed to the intervention and control groups. The group to which the case would be assigned was determined according to the order of hospitalisation and recorded in the Excel list.

Since the care intervention and data collection in the study were carried out by the researcher, one-way blinding was performed.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • To agree to participate in the research with a partner.
  • Speak and understand Turkish.
  • To be 18 years of age or older.
  • To be at least primary school graduate.
  • Having experienced loss after spontaneous pregnancy.
  • Not being diagnosed with a psychiatric illness.

排除标准

  • Pregnancy loss due to medical termination
  • Being pregnant with assisted reproductive techniques and experiencing pregnancy loss

结局指标

主要结局

perinatal grief level

时间窗: 30 days/1 month

The Perinatal Grief Scale (32-item Short Version) developed by Toedter et al. consists of 32 items on a 5-point Likert scale. This scale assesses the degree of grief after perinatal loss. Each question on the scale was answered as 'Strongly agree, agree, undecided, disagree, strongly disagree. ' Active grief, hopelessness, and difficulty in coping were subscales of the scale. As the total perinatal grief score and the total score obtained from the subdimensions increased, it was determined that the grief level of the individual was higher. The total perinatal grief score obtained from the PMS was between 32-160. The Turkish validity and reliability of the scale was performed by 4 academicians in 2017 and the content validity index was found to be 0.95. In this study, the Cronbach's alpha value of the scale was 0.774.

General Well-Being Scale Short Form

时间窗: 30 days later

The short form of the General Well-being Scale was created as a result of the factor analysis studies of the shortening of the General Well-being Scale consisting of 65 items developed by Longo et al. in 2017 to determine the well-being of individuals. The General Well-Being Scale Short Form consisted of 14 items. In the five-point Likert-type scale, there are items such as Everything I do is valuable. "1" is not true at all and "5" is always true. The Turkish validity and reliability of the scale was carried out by 3 academicians in 2021, and as a result of the reliability studies, the internal consistency coefficient and construct reliability of the scale were found to be 0.84 and the two-half test correlation was 0.77. In this study, Cronbach's alpha value of the scale was 0.848.

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayça Demir Yıldırım, PhD

Assistant Professor

Istanbul University - Cerrahpasa (IUC)

研究点 (2)

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