The Effect of Virtual Reality Application on Anxiety and Milk Quantity in Mothers Who Milk Their Babies by Milking
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Personal Information Form
研究概览
简要总结
The research was conducted at the Istanbul Zeynep Kamil Women's And Children's Diseases Education And Research Hospital's Maternity Service between the dates of June 15 and December 31, 2025. It is a randomized controlled experimental research. The data consist of a total of 32 primiparous mothers whose baby was hospitalized in the neonatal intensive care unit who met the criteria for inclusion in the study. Mothers were divided into groups (16 experiments, 16 controls) by randomization method. The data of the research were collected using the Personal Information Form, the Status Anxiety Scale and the Inadequate Milk Perception Scale after obtaining the permission of the ethics committee and the institution. Virtual reality glasses were applied to the mothers in the experimental group. Only routine clinical care was applied to the mothers in the control group.
详细描述
Type of Research: It is a randomized controlled experimental research type.February Decembers/Sample of the Research: The research will be conducted between 3 February 2025-31 December 2025 after obtaining the approval of the ethics committee and the authorizations of the institution.
February December 3, 2025-31, 2025, SBU Zeynep Kamil Women's and Children's Diseases Training and Research Hospital Dec. 3, 2025, the universe of the research will be composed of primiparous mothers whose baby is hospitalized in the neonatal unit. Primiparous mothers (a total of 32 mothers) who participated wholeheartedly in the study will constitute the sample.
Working Group Power analysis was performed to determine the number of people to be included in the research. The strength of the test was calculated using the G*Power 3.1 program. As a similar research in the relevant literature, the effect size of the change in the amount of breast milk was calculated as 1.354 in the study conducted by Herlina et al. (2022). In order to exceed the 99% value in determining the strength of the study, it is necessary to reach 26 people, including 13 people in groups with a significance level of 5% and an effect size of 1,354(df=41; t=1,683). In the research, it was aimed to reach a total of 32 people, including 16 people in groups, taking into account the high strength of the test and the losses.
Statistical Analysis of the Data The data obtained in the research will be analyzed using the Statistical Package for Social Sciences (SPSS) for Windows 22.0 program. The Kolmogorov Smirnov Test will be used to determine whether the research data are distributed normally. According to the Kolmogorov Smirnov Test, if p>0.05, the distribution is determined to be normal. However, if p<0.05, it is determined that the distribution is not normal and the Skewness and Kurtosis values of the data are checked. If the Skewness and Kurtosis values are between +2 and -2, it is assumed that the variable shows a normal distribution (George, Dec and Mallery, 2010). The homogeneity of the descriptive characteristics between the groups will be tested by chi-square analysis.Dec. For the difference between the averages of two independent groups, the data will be evaluated using the t-test if they are Decently distributed, and the Mann-Whitney U test if the data are not decently distributed. Changes in measurements within the group if the data are distributed normally, repeated measurements will be analyzed by Anova test, and if the data are not distributed normally, Friedman test.
The Hypotheses of the Research H1. Virtual reality application is effective in increasing the amount of breast milk.
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 (Investigator)
盲法说明
virtual reality glasses will be applied to the experimental group that was blinded, and routine clinical care will be given to the control group that was blinded.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• those between the ages of 18-35 December
- •Who is at least the first school graduate
- •Who can speak and understand Turkish
- •who gives birth to a single term at 37-42 weeks of pregnancy
- •The primiparous one
- •Who gives vaginal birth
- •Without any risk related to pregnancy and childbirth
- •The baby is in the neonatal intensive care unit
- •Giving milk to your baby by milking
- •Without any chronic systemic diseases
- •End of birth 1-
- •what happened between the Dec
- •Mothers who volunteer to participate in the study and approve the consent document will be accepted to the study.
排除标准
- •• With the loss of a baby during the study phase
- •Those who do not want to participate in the study or who voluntarily participated in the study but later gave up will be excluded from the study.
研究组 & 干预措施
experimental group
virtual reality glasses will be applied
干预措施: virtual reality glasses (Device)
control group
only routin clinical care will be applied
干预措施: routine care (Behavioral)
结局指标
主要结局
Personal Information Form
时间窗: 2 weeks
In accordance with the relevant literature information provided by the researchers (Sari Ozturk and Demir, 2023; Ferraz Dos Santos et al., 2020) developed (Personal Information Form socio-demographic variables belonging to mothers (age, education level, income level, etc.) obstetric characteristics (pregnancy, miscarriage, number and shape of birth, etc.) consists of 33 questions related to breastfeeding and anxiety.
The Status Anxiety Scale
时间窗: 2 weeks
The status-continuous anxiety scale is a self-assessment questionnaire consisting of short statements. It has been adapted to Turkish by Öner and Le Compte. In this study, only the State Anxiety subscale was used. The reason for this is that the Situational Anxiety Scale describes how an individual feels at a certain moment and under certain conditions, and includes a response taking into account their feelings about the situation they are in, Cronbach's Alpha internal consistency coefficient for the situational anxiety scale was found to be between 0.94 and 0.96 in reliability analyses. Dec. The state anxiety scale consists of a scale consisting of a total of twenty items. There is no time limit for responding to the scale. The emotions or behaviors expressed in the items of the state anxiety scale are answered by marking one of the following styles according to the degree of severity of such experiences: (1) none, (2) a little, (3) a lot, (4) completely.
Inadequate Milk Perception Scale
时间窗: 2 weeks
Inadequate Milk Perception Scale Developed by McCarter-Spaulding and Kearney in 2001, the scale consists of 6 questions to determine the inadequate perception of breast milk. The first question that questions whether the mother perceives her milk adequately is in the form of "yes" or "no". The other 5 questions are aimed at measuring the perception of milk Deciency and are scored between 0-10. "0" indicates that milk is completely inadequately perceived, "10" indicates that milk is completely adequately perceived. The scale is scored between 0-50 Dec. A high score indicates that the competence perception of milk has increased. The Cronbach α value was determined as 0.81 in the original of the scale (McCarter-Spaulding \& Kearney, 2001). The validity reliability of the scale in Turkish was made by Gökçeoğlu and Küçükoğlu and the Cronbach α value of the study was found to be 0.82 (Gökçeoğlu, 2014).
次要结局
未报告次要终点
研究者
Zümrüt Bingin
associate professor
Marmara University