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临床试验/NCT05797363
NCT05797363尚未招募不适用

The Effect of Continuous Midwife Support During Pregnancy, Childbirth and Postpartum Processes Starting From Preconceptional Period on Various Parameters Related to Pregnancy, Delivery and Postpartum Period: A Randomized Controlled Study"

Amasya University0 个研究点目标入组 150 人开始时间: 2023年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
主要终点
CHILDBIRTH FEAR - PRIOR TO PREGNANCY SCALE (CFPPS)

研究概览

简要总结

There is a need for studies with a high level of evidence regarding the effect of supportive care given during the preconceptional period, pregnancy, childbirth and postpartum processes. With this planned study, it is aimed to evaluate the effect of continuous midwife support during pregnancy, birth and postpartum periods, starting from the preconceptional period, on various parameters related to pregnancy, birth and postpartum period. The research is planned as a randomized controlled experimental study. It consists of two groups, the study group and the control group. 75 women out of 150 women will form the control group and 75 women will form the study group. The women in the working group will be given individual training in line with their needs. Data will be collected by using the checklist and many scales used by the control and study groups in preconceptional counseling recommended by ACOG (American College of Obstetricians and Gynecologists).

详细描述

INTRODUCTION Globally, midwives are the primary caregivers of women during pregnancy, childbirth, and postpartum. It is recommended to use a midwife-led care model to provide support and assistance to women during pregnancy, childbirth, and the postpartum period. In midwife-led care, midwifery provides quality health care services to women and newborns during pregnancy, delivery, and the postpartum period. Therefore, the evidence-based literature from developed and developing countries emphasizes that maternal and neonatal mortality can be reduced with midwife-led care. Studies suggest that the constant presence of midwives during pregnancy, childbirth, and postpartum period encourages women. Continuity of care increases women's trust in midwives.

In the literature, no study has been found in which the effect of midwifery care initiated in the preconceptional period on pregnancy, birth or postpartum processes has been investigated. For this reason, it is thought that the research will provide meaningful data to the literature.

METHOD

The research is planned as a randomized controlled experimental study. Randomization is planned to be done by the second researcher in a computer environment using the www.randomizer.org internet address. Women numbered 1-150 will be assigned to the study and control groups. The assignment of women to the groups, analysis, and reporting stages will be done by the second researcher, and data collection, training, and follow-up will be done by the first and third researchers. Thus, data collection, training, and follow-up for the second researcher, and the assignment of women to the group for the first and third researcher, analysis, and reporting will be blinded. It consists of two groups, the study group, and the control group. 150 women who applied to Family Health Centers to get a health report for marriage and agreed to participate in the study will be identified. 75 women out of 150 women will form the control group and 75 women will form the study group. The control list used in preconception counseling recommended by ACOG (American College of Obstetricians and Gynecologists) and the scales will be used by both the control and study groups. The pregnancy, delivery, and postpartum period processes of 150 women will be followed starting from the preconception period. 75 women will be given training in line with their individual needs. 75 women will not be given any training. The data will be analyzed using the SPSS package program. Appropriate statistical analysis tests will be used in the analysis of the data by looking at the normality distribution.

Intervention group

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
19 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • She's newly married.
  • Women without children.

排除标准

  • women's desire to stop working

结局指标

主要结局

CHILDBIRTH FEAR - PRIOR TO PREGNANCY SCALE (CFPPS)

时间窗: average of 1 year

CFPPS: While the minimum score on the scale is 10, the maximum score is 60. A high item total score indicates a high level of fear.

Perception of Pregnancy Risk Scale (PPRS)

时间窗: average of 1 year

PPRS: An increase in the score obtained from the scale is interpreted as an increase in the risk perception of the pregnant woman and her baby.

Pregnancy-related Anxiety Scale (PrAS)

时间窗: average of 1 year

PrAS: The cut-off score calculated for the scale is 75.5. A total score of 75.5 and above indicates an increased anxiety level due to pregnancy.

Pregnancy Experience Scale (PES)

时间窗: average of 2 year

PES: A total of six sub-dimension scores (positive emotions frequency score, negative emotions frequency score, positive emotions intensity score, negative emotions intensity score, frequency ratio and intensity ratio) are obtained in GDS.

Self-perception of Pregnants Scale (SPS)

时间窗: average of 2 year

SPS: When evaluating the scores of the Pregnancy Body Perception sub-dimension, high scores indicate negative pregnancy body perception, and low scores indicate positive pregnancy body perception. The highest score that can be obtained in the Pregnancy Body Perception sub-dimension is 20, and the lowest score is 5.

Oxford Birth Anxiety Scale (OBAS)

时间窗: average of 2 year

OBAS: The scale is evaluated over the total score (min=10, max=40). As the score increases, it is interpreted that the anxiety level of women increases.

Childbirth Comfort Questionnaire (CCQ)

时间窗: average of 3 year

CCQ: The minimum score that can be obtained from the scale is 14, the highest score is 70. As the score increases, it is said to be high-level comfort, and as the score decreases, low-level comfort is mentioned.

Antenatal Perceived Stress Scale (APSS)

时间窗: average of 1 year

APSS: The perceived stress score during pregnancy is obtained by summing the item scores in the scale and then dividing by the number of items. While the lowest score that can be obtained from the scale is 1, the highest score is 5. The high total score obtained from the scale indicates the highest perceived stress level in pregnant women.

Postpartum Quality of Life Questionnaire (PQLQ)

时间窗: average of 3 year

PQLQ: The higher the score obtained from the scale, the higher the person's postpartum quality of life, and lower scores the lower the postpartum quality of life.

Prenatal breastfeeding self efficacy scale (PBSeS)

时间窗: average of 1 year

PBSeS: Each item of the scale is graded as a 5-point Likert type. The lowest score that can be obtained from the total of the scale is 20, and the highest score is 100. The higher the score, the higher the perception of breastfeeding self-efficacy.

Family Planning Attitude Scale (FPAS)

时间窗: average of 1 year

FPAS: The scale is a five-point Likert-type scale consisting of 34 items. The lowest 34 and the highest 170 points can be obtained from the scale, and an increase in the total score means a more positive family planning attitude.

Prenatal Care Satisfaction Scale (PCSS)

时间窗: average of 1 year

PCSS: There is no cut-off point in the evaluation of the scale. The higher the score obtained from the scale, the higher the satisfaction, and the lower it is, the lower the satisfaction.

HEALTH PRACTICES QUESTIONNAIRE IN PREGNANCY

时间窗: average of 2 year

The highest score that can be obtained from the scale is 165, and the lowest score is 33. High scores indicate good health practices.

MOTHERS' POSTNATAL SENSE OF SECURITY SCALE (MPSSS)

时间窗: average of 3 year

MPSSS: Scores from the scale range from 18 to 72, and high scores indicate good feelings of security.

Postpartum Sleep Quality Scale (PSQS)

时间窗: average of 3 year

PSQS: The lowest 0 and the highest 56 points can be obtained from the scale and there is no cut-off point. An increase in the score indicates a decrease in sleep quality.

SCALE OF WOMAN'S PERCEPTION OF SUPPORTIVE CARE GIVEN TO WOMAN IN LABOR

时间窗: average of 3 year

At least 33 from the scale; maximum 132 points are taken. There is no cut-off point in the scale. The higher the score from the scale, the better the supportive nursing care received.

Childbirth Self-Efficacy Scale (CSES)

时间窗: average of 3 year

CSES: The lowest total score that can be obtained from the scale is 32, and the highest total score is 320. High scores from the scale show that pregnant women have high self-efficacy levels in labor.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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