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临床试验/NCT05326854
NCT05326854Unknown不适用

EVALUATION OF THE EFFECTIVENESS OF THE NAVIGATION ASSISTED CARE PROGRAM FOR WOMEN WITH MEDICAL TERMINATION

Eskisehir Osmangazi University2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2021年9月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
perinatal grief-2

研究概览

简要总结

This study was planned to evaluate the effectiveness of the navigation-assisted care program based on the Swanson Theory of Care, which was developed for women who underwent medical termination as a result of a complication caused by maternal or fetal reasons.

详细描述

H1: Navigation-assisted care program based on Swanson care theory reduces perinatal grief levels of women.

H2: Navigation-assisted care program based on Swanson care theory reduces depression-anxiety-stress levels of women

H3: Navigation-assisted care program based on Swanson care theory positively affects women's coping and adjustment levels.

Independent variables: Sociodemographic characteristics such as age, marital status, educational status and the Navigation Assisted Care Program Based on Swanson Care Theory constitute the independent variables.

Dependent variables: Scores from Perinatal Grief Scale, Depression, Anxiety and Stress Scale, Coping and Adaptation Process Scale, discharge time, labor pain constitute the dependent variables.

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)

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

  • 18 years and over,
  • Able to read and write,
  • Agreeing to participate in the study,
  • Accepting the decision of medical termination of pregnancy,
  • Does not have a diagnosed psychiatric disease,
  • Medical termination decision is taken in the first and second trimesters,
  • Women who have a phone that can use the mobile application program will be included in the study.

排除标准

  • Being under the age of 18,
  • Those who do not agree to participate in the study,
  • Women who do not have a phone that can use the mobile application program will not be included in the study.

结局指标

主要结局

perinatal grief-2

时间窗: 8th weeks

Evaluation will be made using the scale. Change will be evaluated at the 7th interview (at 6-8weeks) using the Perinatal grief scale Changes in the age of the patients over time will be evaluated. It will increase-decrease over time. The scale does not have any cutoff points. As the scale score increases, the level of grief increases

perinatal grief-1

时间窗: 2nd or 3rd days

Evaluation will be made using the scale. Change will be evaluated at the after termination(birth) using the Perinatal grief scale Changes in the age of the patients over time will be evaluated. It will increase-decrease over time. The scale does not have any cutoff points. As the scale score increases, the level of grief increases The termination process of the patients may vary. The perinatal grief scale is first administered in the hospital after termination.

depression-anxiety-stress-1

时间窗: 2nd or 3rd days

Change will be evaluated at the after termination(birth) using the Depression Anxiety Stress Scale-21. The depression anxiety stress scale is first interwiev in the hospital after termination. The patient is followed as long as he stays in the hospital.(avarage3-4 days) Depression anxiety stress level of the patients will be evaluated. Scale has certain cutoff points. Women's depression, anxiety and stress will be examined. Changes will be observed over time. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue. Depression Anxiety Stress (Respectively) NORMAL 0-4 0-3 0-7 MILD 5-6 4-5 8-9 MEDİUM LEVEL 7-10 6-7 10-12 HIGH LEVEL 11-13 8-9 13-16 VERY HIGH 4+ 10+ 17+

depression-anxiety-stress-3

时间窗: 12th weeks

Change will be evaluated at the 8th interview (at 10.-12weeks) using the Depression Anxiety Stress Scale-21. The depression anxiety stress scale is first interwiev in the hospital after termination. The patient is followed as long as she stays in the hospital.(avarage3-4 days) Depression anxiety stress level of the patients will be evaluated. Scale has certain cutoff points. Women's depression, anxiety and stress will be examined. Changes will be observed over time. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue. Depression Anxiety Stress (Respectively) NORMAL 0-4 0-3 0-7 MILD 5-6 4-5 8-9 MEDİUM LEVEL 7-10 6-7 10-12 HIGH LEVEL 11-13 8-9 13-16 VERY HIGH 4+ 10+ 17+

depression-anxiety-stress-2

时间窗: 8th weeks

Change will be evaluated at the 7th interview (at 6-8weeks using the Depression Anxiety Stress Scale-21. The depression anxiety stress scale is first interwiev in the hospital after termination. The patient is followed as long as he stays in the hospital.(avarage3-4 days) Depression anxiety stress level of the patients will be evaluated. Scale has certain cutoff points. Women's depression, anxiety and stress will be examined. Changes will be observed over time. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue. Depression Anxiety Stress (Respectively) NORMAL 0-4 0-3 0-7 MILD 5-6 4-5 8-9 MEDİUM LEVEL 7-10 6-7 10-12 HIGH LEVEL 11-13 8-9 13-16 VERY HIGH 4+ 10+ 17+

coping and adaptation-3

时间窗: 12th weeks

Evaluation will be made using the scale. Coping and adaptation scale Change will be evaluated at the 8th interview (at 10.-12weeks) using the Coping and Adaptation Process Scale The increase in the coping and adjustment levels of the patients will be evaluated. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue.

coping and adaptation-1

时间窗: first day

Evaluation will be made using the Coping and adaptation scale. Change will be evaluated in the hospital before termination(birth), using the Coping and Adaptation Process Scale The increase in the coping and adjustment levels of the patients will be evaluated. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue. The Coping and Adaptation process scale, on the other hand, is first applied in the hospital after the hospitalization of the patients.

coping and adaptation-2

时间窗: 8th weeks

Evaluation will be made using the scale. Coping and adaptation scale Change will be evaluated at the 7th interview (at 6-8weeks) using the Coping and Adaptation Process Scale The increase in the coping and adjustment levels of the patients will be evaluated. Follow-up covers a period of 10-12 weeks. In this process, both follow-up and supportive care continue.

Labor Pain-1

时间窗: first day

Evaluation will be made using the VAS scale in hospital. The change in pain scores of the experimental group and the control group will be compared. 1-The latent phase covers the period until the 3-4 cm gap in labor occurs. The pain he feels during this time will be measured with a visual analog scale. This process can take up to 1 day on average.

perinatal grief-3

时间窗: 12th weeks

Evaluation will be made using the scale. Change will be evaluated at the 8th interview (at 10-12weeks) using the Perinatal grief scale Changes in the age of the patients over time will be evaluated. It will increase-decrease over time. The scale does not have any cutoff points. As the scale score increases, the level of grief increases

Labor Pain-3

时间窗: first day

Evaluation will be made using the VAS scale in hospital. The change in pain scores of the experimental group and the control group will be compared. 3-The pain felt by the baby for the first two hours after the action occurs will be measured with the visual analog scale. This process can take up to 1 day on average.

Labor Pain-2

时间窗: first day

Evaluation will be made using the VAS scale in hospital. The change in pain scores of the experimental group and the control group will be compared. 2-Pain during the act (baby's exit) will be measured with the visual analog scale. This process can take up to 1 day on average.

次要结局

  • discharge time(Avarage 3-4 days)
  • quality of sleeping(12th weeks)

研究者

发起方
Eskisehir Osmangazi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

havva yeşildere sağlam

Sub-Investigator

Eskisehir Osmangazi University

研究点 (2)

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