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临床试验/NCT05735821
NCT05735821招募中不适用

Comparison of Video and Breastfeeding Simulator Supported Training Activities for Mothers Who Couldn't Breastfeed Their Baby Staying in the Mother's Hotel

HATİCE TETİK METİN1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
In education groups; Measuring breastfeeding efficacy with the Breastfeeding Self-Efficacy Scale-Short Form

研究概览

简要总结

The study was planned as a randomized controlled study to evaluate the effectiveness of breastfeeding behavior development training using Video and Simulator, given to mothers whose babies are in the neonatal intensive care unit and who are staying in the mother's guesthouse.

As soon as the mothers who are separated from their babies and who have breastfeeding barriers come together with their babies and the breastfeeding barrier is lifted, to enable them to start breastfeeding effectively the effectiveness of the training, which will be given by applying 2 different methods based on the IMB (Knowledge, Motivation, Behavioral Skills) model will be evaluated.

The aim of the training is to develop breastfeeding behavior in mothers and to ensure a secure attachment between mother and baby.

(The research will be conducted in a randomized controlled trial model with a pretest-posttest control group.)

详细描述

The universe of the research; Bitlis State Hospital Newborn Unit will be formed by mothers whose babies are hospitalized and who stay at the mother's hotel.

Sample of the research:

G.Power 3.1.9.4 package program was used to calculate the sample size foreseen for the research. In the calculation made in this direction; sample size, 95% confidence interval, 0.6 effect value for 80% power was used, and it was seen that at least 90 individuals should be included in the study in total. Since the study will be conducted in 2 intervention and 1 control groups, it has been observed that there should be 30 people in each group.

Content of the Training Provided for Developing Breastfeeding Behavior Change; Training materials and training contents will be created by the researcher based on the IMB Model and the training will be planned. Trainings will be video supported and simulator supported. The video will be prepared by the researcher. The video will be prepared in accordance with the techniques of 'educational video development for e-Learning'. Breastfeeding Simulator will be tried to be obtained by applying to the Tübitak project. If Tübitak project support cannot be obtained, the Breastfeeding Simulator will be provided by the researcher.

Data collection stages: Participants who meet the sample selection criteria will be informed about the scope of the research and their verbal and written consent will be obtained.

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
Quadruple (Participant, Care Provider, Investigator, 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

  • Be 18 years or older,
  • Mothers whose babies were admitted to the neonatal unit after delivery and stayed in the mother's guesthouse,
  • Mothers of infants who did not breastfeed and bond within the first 30-60 minutes after birth and were immediately admitted to the newborn,
  • Mothers who have not started breastfeeding their babies,
  • Literate,
  • Ability to understand and answer questions

排除标准

  • Mothers whose babies were admitted to the neonatal unit after 24 hours
  • Mothers who do not stay in the mother's guesthouse

结局指标

主要结局

In education groups; Measuring breastfeeding efficacy with the Breastfeeding Self-Efficacy Scale-Short Form

时间窗: at admission

The minimum score to be obtained from the breastfeeding self-efficacy scale is 14, and the maximum score is 70. A high score indicates high breastfeeding self-efficacy.

In the control group; Measuring breastfeeding efficacy with the Breastfeeding Self-Efficacy Scale-Short Form

时间窗: at admission

The minimum score to be obtained from the breastfeeding self-efficacy scale is 14, and the maximum score is 70. A high score indicates high breastfeeding self-efficacy.

In education groups; Measuring the bond between mother and baby with the Maternal Attachment Scale

时间窗: at admission

The lowest score that can be obtained from the Maternal Attachment Scale is 26, and the highest score is 104. The Highest Score Indicates High Maternal Attachment.

In education groups; Determining the Percentage of the Number of Correct Answers to the Questions Regarding the Determination of Attitudes and Knowledge Levels towards Breastfeeding

时间窗: at admission

The questionnaire on Determining Attitudes and Knowledge Levels towards Breastfeeding consists of 14 questions.

In education groups; Evaluation of personal data, obstetric data and newborn information with the Sociodemographic Data Questionnaire

时间窗: at admission

31 questions were created by the researcher by scanning the literature on the subject. The questions included women's socio-demographic characteristics, obstetric histories and newborn information.

In the control group; Measuring the bond between mother and baby with the Maternal Attachment Scale

时间窗: at admission

The lowest score that can be obtained from the Maternal Attachment Scale is 26, and the highest score is 104. The Highest Score Indicates High Maternal Attachment.

In the control group; Evaluation of personal data, obstetric data and newborn information with the Sociodemographic Data Questionnaire

时间窗: at admission

31 questions were created by the researcher by scanning the literature on the subject. The questions included women's socio-demographic characteristics, obstetric histories and newborn information.

In the control group; Determining the Percentage of the Number of Correct Answers to the Questions Regarding the Determination of Attitudes and Knowledge Levels towards Breastfeeding

时间窗: at admission,

The questionnaire on Determining Attitudes and Knowledge Levels towards Breastfeeding consists of 14 questions.

次要结局

  • In education groups; Measuring the bond between mother and baby with the Mother Attachment Scale after the training given with the video and breastfeeding simulator(1 week after training and 1 month after retraining)
  • In the control group; Measuring breastfeeding efficacy with the Breastfeeding Self-Efficacy Scale-Short Form(1 month after entry)
  • In the control group; Determining the Percentage of the Number of Correct Answers to the Questions Regarding the Determination of Attitudes and Knowledge Levels towards Breastfeeding(1 month after entry)
  • In education groups; Evaluation of Breastfeeding Efficiency with the Breastfeeding Self-Efficacy Scale-Short Form after the training given with the video and breastfeeding simulator(1 week after training and 1 month after retraining)
  • In education groups; Determining the Rate of Correct Answers to the Questions Regarding the Determination of Attitudes and Knowledge Levels towards Breastfeeding after the training given with the video and breastfeeding simulator(1 week after training and 1 month after retraining)
  • In the control group; Measuring the bond between mother and baby with the Maternal Attachment Scale(1 month after entry)

研究者

发起方
HATİCE TETİK METİN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

HATİCE TETİK METİN

Principal Investigator

Hasan Kalyoncu University

研究点 (1)

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