跳至主要内容
临床试验/NCT05361265
NCT05361265已完成不适用

THE EFFECT OF FETAL MOVEMENT COUNTING ON PRENATAL MATERNAL ATTACHMENT AND DISTRESS IN PREGNANCY

Gazi University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
distress in pregnancy

研究概览

简要总结

Purpose: This study aimed to determine the effect of fetal movement counting on prenatal maternal attachment and distress in pregnancy.

Methods: This is a quasi-experimental study. The population of the study consisted of of 60 primigravida pregnant women (30 experimental and 30 control groups) being in 28 to 32 weeks gestation. The Prenatal Attachment Inventory (PAI) and the Tilburg Pregnancy Distress Scale (TPDS) used for data collection. After the pre-tests (28 to 32 weeks gestation), the experimental group were trained about fetal movement counting. The experimental group performed fetal movement counting for at least four to six weeks. The post-tests were filled in 32 to 38 weeks gestation. The control group received only pre-tests and post-test in the same weeks gestation with the experimental group.

详细描述

This is a quasi-experimental study.

The population of the study consisted of pregnant women followed in a State Hospital in the capital city of Turkey in 2019. Power analysis (Sample error: 0.01 and power: 95%) was performed to determine the sample size of the study. In the power analysis, the mean score of the Prenatal Attachment Inventory was 71.88 ± 8.25 [15] and the mean score of the Tilburg Pregnancy Distress Scale was 18.86 ± 7.37 [16]. The minimum number of participants required for each group was 24 (α = 0.05, 1-β = 0.80). To increase the reliability and validity of the study, the study sample consisted of 60 pregnant women (30 experimental and 30 control groups). The criteria for inclusion in the research sample were; being in 28 to 32 weeks gestation, primigravity, being at least literate, not having any chronic or psychiatric disease, not having any communication disability (speech, hearing, mental), non-risky pregnancy (preeclampsia, gestational diabetes, advanced age, and adolescent pregnancy, etc.), current or recent pregnancy is identified as not having any significant life difficulties (loss, illness, accident, etc.). The experimental and control groups were matched to be similar in terms of age, education and working status parameters.

Data Collection Instruments:

Research data were collected using the Descriptive Information Form, the Prenatal Attachment Inventory (PAI), the Tilburg Pregnancy Distress Scale (TPDS) and the Fetal Movement Monitoring Card.

In the Descriptive Information Form, there are five questions including the socio-demographic informations of the pregnant women (age, education status, working status, and perceived income) and the gestational week.

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
None

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • being in 28 to 32 gestation weeks
  • primigravidity
  • at least literate

排除标准

  • illiteration
  • chronic or psychiatric disease
  • communication disability (speech, hearing, mental)
  • risky pregnancy

结局指标

主要结局

distress in pregnancy

时间窗: 4-6 weeks

the Tilburg Pregnancy Distress Scale: The scale was developed for the diagnosis of distress in pregnancy \[11\]. The scale consists of a total of 16 items. The scale has two subscales. Negative Affect subscale consists of 12 items including fear, anxiety and negative perceptions regarding pregnancy, childbirth and the postpartum period. Partner Involvement subscale consists of 4 items related to spousal support during pregnancy. The scale is a four-point Likert type and each item is scored between 1 and 3 (0: very often, 1: quite often, 2: sometimes, and 3: rarely or never). The points 3.5,6,7,9,10,11,12,13,14 and 16 are interpreted by reversing them. The highest score of the scale is 48 and the lowest score is 0. A high score from the scale indicates that pregnant women are at risk for distress.

prenatal maternal attachment

时间窗: 4-6 weeks

the Prenatal Attachment Inventory: The inventory was developed to explain the feelings, thoughts, and situations of women during pregnancy and to determine their attachment levels to the baby in the prenatal period \[17\]. The scale consists of 21 items in total. In the 4-point Likert scale, each item can score between 1 and 4 points (1: Never, 2: Sometimes, 3: Frequent, 4: Always). The highest score of the scale is 84, the lowest score is 21, and the high scale score indicates the high level of prenatal attachment.

次要结局

未报告次要终点

研究者

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

Şengül Yaman Sözbir

Assoc Prof

Gazi University

研究点 (2)

Loading locations...

相似试验