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临床试验/NCT05901298
NCT05901298招募中不适用

Development of 'My Breastfeeding Guide' Mobile Nursing Application and Its Effect on Breastfeeding Process, Self-Efficacy, Infant Nutrition and Attachment

Eastern Mediterranean University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
88
试验地点
1
主要终点
Pregnant Introduction Form

研究概览

简要总结

The research was planned to develop the "My Breastfeeding Guide" mobile nursing application, which was developed based on Dennis' Breastfeeding Self-Efficacy Theory and Pender's Health Promotion Model, and to determine its effect on the postpartum breastfeeding process, breastfeeding self-efficacy, infant feeding and attachment. The research is in randomized controlled experimental and longitudinal (prospective) design. The research will be carried out with pregnant women who applied to Famagusta State Hospital Obstetrics and Gynecology Polyclinic and a pregnant polyclinic of a private hospital in Famagusta. Pregnant women who applied to Famagusta State Hospital Gynecology and Obstetrics Polyclinic and private hospital's pregnancy polyclinic and met the inclusion criteria of the study will constitute the population of the research. The research will be designed in two groups as the mobile nursing practice group (intervention) and standard care group (control) developed based on Dennis's Breastfeeding Self-Efficacy Theory and Pender's Health Promotion Model. By calculating the sample size in the research, 44 people in the intervention group and 44 people in the control group will reach a total of 88 people. Pregnant Identification Form, Maternal Information Form, Breastfeeding Self-Efficacy Short Form Scale (Postnatal Form), Antenatal Self-Efficacy Short Form Scale, Infant Nutrition Attitude Scale, Breastfeeding Rating Scale, Maternal Attachment Scale and Breastfeeding Self-assessment Form will be used to collect data. Statistical analyzes of the data obtained from the research will be made using the Statistical Package for the Social Science (SPSS) 20.0 package program. While evaluating the research data, frequency, percentage, mean, standard deviation, median, variance analysis from descriptive statistical methods will be used. For homogeneity test between intervention and control groups, the Chi-square test for categorical variables, Mann Whitney test for numerical variables, and sociodemographic variables (age, education status, employment status of himself and his spouse, income level, etc.) and whether the groups are similar in terms of some characteristics. U test will be used. The conformity of the scale scores to the normal distribution will be evaluated with the Shapiro-Wilk test. The results will be evaluated at the 95% confidence level, and the significance at the p<0.05 level.

详细描述

Aim:

The research was planned to develop the "My Breastfeeding Guide" mobile nursing application, which was developed based on Dennis' Breastfeeding Self-Efficacy Theory and Pender's Health Promotion Model, and to determine its effect on the postpartum breastfeeding process, breastfeeding self-efficacy, infant feeding and attachment.

Hypotheses:

  1. H1: Postpartum breastfeeding self-efficacy score averages of the intervention group using the mobile nursing application developed based on the model are higher than the control group.
  2. H1: Postpartum infant feeding attitude mean score of the intervention group using the mobile nursing application developed based on the model is higher than the control group.
  3. H1: Postpartum breastfeeding mean score of the intervention group using the mobile nursing application developed based on the model is higher than the control group.
  4. H1: Postpartum maternal-newborn attachment point averages of the intervention group using the mobile nursing application developed based on the model are higher than the control group.

Type of Research:

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)

盲法说明

Simple random sample selection will be made using the 'www.randomizer.org' program, and the pregnant women who accepted to participate in the study will be divided into intervention and control groups. To ensure randomization; Age, education level and number of births will be matched. The research will be designed in two groups as the mobile nursing practice group (intervention) and standard care group (control). In the study "The sample size was calculated at the 95% confidence level by using the "G. Power-3.1.9.2" program. As a result of the analysis, with considering the data loss, 10 people will be added to the groups and 44 people will be reached for the intervention group and 44 for the control group.

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

  • Women aged 18 and over,
  • Women who are in the last trimester of pregnancy (32nd gestational week and above),
  • Women with singleton pregnancy,
  • Women who do not have any health problems that may prevent breastfeeding,
  • Women with smartphones with Android and iOS operating systems,
  • Women who can access the Internet,
  • There will be women who do not have literacy problems, mental disabilities and communication problems.

排除标准

  • Women under 18 years of age,
  • Women who are under the last trimester of pregnancy (32nd week of pregnancy),
  • Women who do not speak Turkish,
  • Women who own a smartphone with an operating system other than Android and iOS.

结局指标

主要结局

Pregnant Introduction Form

时间窗: Between 32nd - 42nd gestational week

The Pregnant Introductory Form was created by the researcher using the literature. The form contains personal information and pregnancy information.

Breastfeeding Self-Efficacy Short Form Scale (Postnatal Form)

时间窗: Postpartum first 24-48 hours,1st-6th week, 6th month

The Breastfeeding Self-Efficacy Scale was developed to evaluate the breastfeeding self-efficacy levels of mothers. The lowest score that can be obtained from the scale is 14, and the highest score is 70. A high score indicates that breastfeeding self-efficacy is high.

Maternal Attachment Scale

时间窗: Postpartum 6th week

The Maternal Attachment Scale (MBI) is a 26-item, four-point Likert-type scale developed by Mary E. Muller in 1994 to measure attachment with maternal love. Turkish validity and reliability of the scale was done by Kavlak and Şirin in 2009. The lowest score that can be obtained from the scale is 26, and the highest score is 104. A high score indicates high maternal attachment. It is recommended to apply the scale to mothers who have babies between one and four months postpartum.

Antenatal Self-Efficacy Short Form Scale

时间窗: Between 32nd - 42nd gestational week

Antenatal Self-Efficacy Short Form Scale was developed to evaluate the breastfeeding self-efficacy levels of mothers in antenatal period. The lowest score that can be obtained from the scale is 14, and the highest score is 70. A high score indicates that breastfeeding self-efficacy is high.

Infant Nutrition Attitude Scale (BBTS)

时间窗: Between 32nd - 42nd gestational week

The Iowa Infant Feeding Attitude Scale (Iowa Infant Feeding Attitude Scale) evaluates women's attitudes towards breastfeeding and to predict breastfeeding duration as well as the choice of infant feeding method. The total attitude score ranges from 17 (reflecting a positive attitude in bottle feeding) to 85 points (reflecting a positive attitude in breastfeeding).

Breastfeeding Rating Scale (IBFAT)

时间窗: Postpartum first 24-48 hours,1st-6th week

The Infant Breastfeeding Assesment Tool (IBFAT) evaluates the limitations of breastfeeding adequacy at each feeding, and the Turkish validity and reliability of the scale was performed by Çelik and Demirci in 2017. The scale consists of six questions and scores are made based on the answers of the mothers to the questions. Each question is evaluated between 0-3 points and the highest score is 12. The score range for effectively fed infants is 10-12 points.

Mother Introductory Form

时间窗: Postpartum first 24-48 hours,1st-6th week, 6th month

The Mother Identification Form was created by the researcher using the literature. Form consists of a total of 15 questions, such as including information such as feeding the baby, giving a pacifier to the baby, giving a bottle to the baby, breastfeeding frequency in the first 24 hours.

Breastfeeding Self-Assessment Form

时间窗: Postpartum first 24-48 hours,1st-6th week, 6th month

The Breastfeeding Self-Assessment Form was created by the researchers on the basis of the Turkish Ministry of Health Breastfeeding Observation Form, in order for the mothers in the intervention group to evaluate their breastfeeding through the 'My Breastfeeding Guide' mobile nursing application. The form includes body position, baby's behavior, time spent sucking and sucking. This form does not have a scoring system. The purpose of using the form is for mothers to evaluate their own breastfeeding while using the mobile application.

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

Emine Temizkan Sekizler

Lecturer

Eastern Mediterranean University

研究点 (1)

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