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临床试验/NCT05902481
NCT05902481尚未招募不适用

The Effect of Mixed Reality Technology-Based Breastfeeding Counseling on Breastfeeding Success and Self-Efficacy of Women

Tarsus University0 个研究点目标入组 112 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
112
主要终点
LATCH Breastfeeding Diagnosis and Evaluation Scale

研究概览

简要总结

Breast-feeding; It is the basic step of newborn, maternal and community health. Breastfeeding counseling, which is planned to encourage, initiate and continue breastfeeding in line with the recommendations of the World Health Organization, is extremely important in order to achieve the Sustainable Development Goals. Breastfeeding counseling with mixed reality technology will contribute to the literature.

The research will be carried out between January 2023 and December 2024 in the hospitals in Mersin with a delivery room. The universe will consist of all pregnant women who come to the obstetrics clinics of the specified hospitals for follow-up purposes. G Power 3.1 program was used for sampling. By using the G Power 3.1 program in the sample calculation (30); According to the Cohen Guidelines (Cohen's d); effect size was 0.5, power was 0.80, and significance level was 0.05. It was calculated as 102 people, with at least 51 people in the intervention group and at least 51 people in the control group. The sample number was determined as 112 pregnant women to receive 10% (5 each) for the intervention and control groups in case the participants dropped out of the study. In the study, "Block Randomization" method, which is one of the fixed probability randomization methods, will be used in order to ensure homogeneity between the groups and to eliminate selection bias.

In the intervention group; Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test to pregnant women in their 3rd trimester and breastfeeding counseling based on mixed reality technology will be given. The LATCH Breastfeeding Diagnosis and Evaluation Scale and Postpartum Breastfeeding Self-Efficacy Scale will be filled in within 24 hours and on the 7th day after giving birth. The same steps will be performed for the pregnant women in the control group, and unlike the intervention group, counseling will be applied with Power Point technique instead of mixed reality technology. Statistical analyzes will be made using a package program called SPSS (IBM SPSS Statistics 24). In descriptive statistical analysis, mean, standard deviation, median, frequency, percentile, minimum and maximum values will be calculated. Descriptive, parametric and nonparametric statistical analysis methods will be used in the analysis of the data.

Various studies have been conducted in Turkey using different methods on breastfeeding counseling, but no study has been found in which breastfeeding counseling was provided with mixed reality technology. Therefore, a randomized controlled experimental type study will be conducted to evaluate the effect of mixed reality technology-based breastfeeding counseling on breastfeeding success and self-efficacy of women.

详细描述

No study has been found in Turkey that provides breastfeeding counseling with mixed reality technology. It is predicted that counseling provided with the use of mixed reality technology will increase breastfeeding self-efficacy and success. It is envisaged that the results obtained will be presented in scientific environments and used as an evidence-based practice in increasing both the rate and success of breastfeeding after being published as an article. The results of a randomized controlled trial with high evidential value are expected to be available for use by both healthcare professionals and mothers. By helping the results of the study to realize the recommendations of the World Health Organization regarding breastfeeding; It is thought that it will benefit newborn, maternal and community health, thus making a significant contribution to the promotion, initiation and maintenance of breastfeeding, which is the first step towards achieving the Sustainable Development Goals.In order to evaluate the effect of breastfeeding counseling based on mixed reality technology on breastfeeding success and self-efficacy of women, it will be conducted in a randomized controlled experimental type.

Methods The research will be carried out between January 2023 and December 2024 in the hospitals in Mersin with a delivery room.

The population of the study will be composed of pregnant women who applied to the obstetrics and gynecology outpatient clinics of hospitals with delivery rooms in Mersin between January 2023 and December 2024 for follow-up. G Power 3.1 program was used for sampling. By using the G Power 3.1 program in the sample calculation (30); According to the Cohen Guidelines (Cohen's d); effect size was 0.5, power was 0.80, and significance level was 0.05. It was calculated as a total of 102 people, with at least 51 for the intervention group (the group given breastfeeding counseling based on mixed reality technology) and at least 51 for the control group (the group where breastfeeding counseling was given with the standard education method). The sample number of the study group was determined as 112 pregnant women, 10% for the intervention group and 10% (5 people) for the control group, against the possibility of the participants dropping out of the study.

Data Collection Intervention Group Data Collection in the Prenatal Period 38-40 students who agreed to participate in our study and met the inclusion criteria. Introductory Information Form, Antenatal Breastfeeding Self-Efficacy Scale will be applied as a pre-test after obtaining informed consent from the pregnant women who are between the 6th and 7th weeks of age. The data will be collected by face-to-face interview technique and is expected to take about 15 minutes.

After the pre-test is applied, pregnant women will be given breastfeeding counseling based on mixed reality technology. Breastfeeding counseling; It is an educational program that includes breast milk and its properties, benefits of breast milk for mother and baby, breast anatomy, breastfeeding positions, expressing and storing breast milk. This counseling will be applied to pregnant women with mixed reality technology and will take approximately 20 minutes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

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

  • Continuing pregnancy between gestational weeks,
  • Primigravida,
  • Those who have not received a planned breastfeeding training before,
  • Pregnant women who agree to participate in the study will be included.

排除标准

  • Having a risky pregnancy,
  • Postpartum mother and/or baby have a health condition that prevents breastfeeding,
  • Having multiple pregnancy,
  • The mother and/or baby hospitalized for the first 7 days,
  • Can't speak or understand Turkish,
  • Women with intellectual disability and serious mental disorders will be excluded from the study.

结局指标

主要结局

LATCH Breastfeeding Diagnosis and Evaluation Scale

时间窗: 1 day

The LATCH Breastfeeding Diagnostic and Evaluation Scale was developed by Jensen et al. in 1994 (36). The Turkish validity and reliability of the scale were performed by Demirhan and Pek in 1997, Koyun in 2001, and Yenal and Okumuş in 2003 (37,38). The LATCH Breastfeeding Diagnostic and Evaluation Scale is a scale filled by the researcher through observation.

Antenatal Breastfeeding Self-Efficacy Scale

时间窗: 1 day

Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed.This scale assesses how competent mothers feel about breastfeeding.The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied both in the antenatal and postnatal periods.

Postpartum Breastfeeding Self-Efficacy Scale

时间窗: 1 day

Breastfeeding Self-Efficacy Scale was developed by Dennis in 1999 and consists of 33 items. Later, the scale was reduced to 14 items by Dennis in 2003 and the Breastfeeding Self-Efficacy Scale Short Form was developed.This scale assesses how competent mothers feel about breastfeeding.The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied both in the antenatal and postnatal periods.The difference of the antenatal form of the scale from the postnatal form is the use of the phrase "future tense" in the scale items.

次要结局

未报告次要终点

研究者

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

Seda Guray

Research assistant

Tarsus University

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