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临床试验/NCT06295939
NCT06295939进行中(未招募)不适用

Effect of Social Support Program on Grief of Pregnancy Loss in Sunpasitthiprasong Hospital: a Randomized Controlled Trial

Sanpasitthiprasong Hospital2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
2
主要终点
The Perinatal Grief Assessment Questionnaire.

研究概览

简要总结

Research Question:

Does participation in a social support program have an impact on the Perinatal Grief Scale of women who experience pregnancy loss through abortion? Research hypothesis

  1. The grief scores from pregnancy loss among women who had to terminate their pregnancies in the group receiving social support program were lower than those in the group receiving standard nursing care.
  2. The grief scores from pregnancy loss among women who had to terminate their pregnancies after receiving the social support program were lower than those before receiving the social support program.

Primary Objectives:

To study the grief and sorrow resulting from the loss of a fetus due to pregnancy termination in women who have undergone social support programs, in comparison to those who have received regular nursing care.

Secondary Objectives:

  1. To investigate the grief and sorrow resulting from the loss of a fetus due to pregnancy termination after receiving social support programs compared to before receiving such programs.
  2. To examine the grief and sorrow following pregnancy termination before returning home and one month after miscarriage.
  3. To explore other outcomes of pregnancy termination, such as complete abortion, uterine curettage, and post-miscarriage complications.

详细描述

Research Methodology:

The research is a randomized controlled trial (RCT) of the single-blinded type. In this design, the evaluator, or research assistant, is unaware of the participants; group assignments, meaning they do not know which individuals belong to the experimental group and which ones belong to the control group.

Population and Sample:

Population: The population for this study comprises females who have undergone abortion and are admitted for post-abortion care at the obstetrics 3 wards in Sunpasitthiprasong hospital.

Sample: The sample for this study will be selected from the aforementioned population. The selection criteria for the sample are defined as follows:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women diagnosed with fetal demise and requiring pregnancy termination.
  • Fetus with abnormalities requiring pregnancy termination.
  • Age between 18 and 45 years.
  • Gestational age not exceeding 24 weeks.
  • No history of mental illness.
  • No hearing, visual, speech impairments, and able to read and write in the Thai language.

排除标准

  • Pregnant women diagnosed with an ectopic pregnancy.
  • Presence of severe complications such as hemorrhage or shock.
  • Women undergoing a pregnancy termination due to criminal abortion.

结局指标

主要结局

The Perinatal Grief Assessment Questionnaire.

时间窗: 1 month

The Perinatal Grief Assessment Questionnaire (Perinatal Grief Scale short version - PGS-33): This questionnaire, translated into Thai by Sukanya Kritiyutanon (2014) and adjusted based on expert suggestions, comprises 33 questions. It evaluates grief on three dimensions: Active grief, Difficulty coping, and Despair. Each question is rated on a 5-point Likert scale (Strongly Agree to Strongly Disagree), with scores ranging from 33 to 165. The higher the score, the higher the level of grief. Scores above 91 indicate a high level of grief.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Adina Srisomboon

Principal Investigator

Sanpasitthiprasong Hospital

研究点 (2)

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