The Effect of Breast Massage and Virtual Reality Application on Lactation in Postpartum Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- The amount of milk produced during breastfeeding
研究概览
简要总结
This randomized controlled study aims to examine the effects of breast massage and virtual reality applications on breastfeeding in women after cesarean delivery. The study will include mothers aged 18-45, who have delivered a healthy baby via cesarean section at an Obstetrics and Gynecology Department of a University Training and Research Hospital located in the Aegean Region. Participants will have no health issues preventing breastfeeding, will have previously received breastfeeding counseling, and will be included after providing informed consent following the explanation of the study's objectives.
The primary research questions addressed in this study are as follows: Does breast massage applied to women after cesarean delivery affect breastfeeding? Does the application of virtual reality to women after cesarean delivery affect breastfeeding?
The research groups will be randomly assigned into three groups-virtual reality, breast massage, and control-before any interventions are applied. Randomization will be performed using the website www.randomizer.org to determine the group allocation for each participant.
In this study, 31 mothers in the virtual reality group will be shown a 15-minute virtual reality video, depicting a river and forest, viewed through a virtual reality headset, in order to create a relaxing and calming environment. This will be done on post-operative day 0, at the 3rd hour, and at the 24th hour. In the breast massage group, 32 mothers will receive breast massage for 15 minutes, administered by the researchers at the same time points (post-operative day 0, 3rd hour, and 24th hour). After the interventions, mothers will be asked to breastfeed their babies, and the babies will be weighed both before and after breastfeeding.
The control group will receive no intervention and will receive standard care (31 women). Infant weight measurements will also be taken at the same times in the control group. After the interventions, the LATCH Breastfeeding Charting System and Documentation Tool, along with the Breastfeeding Self-Efficacy Scale, will be applied to all groups on post-operative day 0, at the 3rd hour, and at the 24th hour.
A descriptive information form will be used to determine the sociodemographic and obstetric features of the participants in the study.
详细描述
Intervention with Virtual Reality:
The use of virtual reality (VR) applications in breastfeeding support after cesarean delivery represents a rare approach in which psychological relaxation is combined with physiological effects. In our study, VR facilitates the relaxation of new mothers through visual and auditory natural landscapes, while also exploring how this technology alleviates stress and anxiety during the breastfeeding process and its effects on milk production, thus filling a unique gap in the literature. Although VR has typically been used in the treatment of psychological disorders in other studies, systematically addressing its concrete effects on breastfeeding provides a new perspective.
The Role of Post-Cesarean Breast Massage in Early Lactation:
The enhancement of lactation after cesarean delivery is generally limited to breastfeeding counseling and psychological support. However, breast massage, as a direct physiological intervention, may play an important role in overcoming physiological barriers caused by cesarean delivery. Given the limited number of studies examining the mechanisms through which breast massage increases milk production, investigating its early-stage effects, particularly in supporting lactation after cesarean delivery, offers an innovative contribution.
Multidimensional and Comprehensive Evaluation Methods:
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 (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
- 是
入选标准
- •Age between 18-45 years
- •Singleton pregnancy in the current gestation
- •Having received breastfeeding counseling during the current pregnancy
- •Gestational age between the 38th and 42nd week
- •Newborn birth weight between 2500-4000 grams
- •No requirement for intensive care for either the mother or the newborn
排除标准
- •Multiple pregnancy in the current gestation
- •Any mental or physical health issues that would prevent breastfeeding
- •Uterine atony
- •Use of medications that would require stopping breastfeeding
- •Any condition that interferes with breastfeeding
- •Congenital anomalies in the newborn (such as cleft palate or cleft lip) that could affect breastfeeding
- •Requirement for intensive care for either the newborn or the mother
研究组 & 干预措施
Breast Massage
In the breast massage group, a breast massage will be applied for 15 minutes.
Virtual Reality
The virtual reality group's participants will be shown a 15-minute virtual reality video depicting a river and a forest, with the aim of creating a relaxing and calming environment.
干预措施: Virtual Reality (Other)
Control Group
No intervention will be applied.
结局指标
主要结局
The amount of milk produced during breastfeeding
时间窗: Post op 24 hour
After the interventions (post-operative day 0, at the 3rd hour, and at the 24th ), mothers will be asked to breastfeed their babies, and the babies will be weighed both before and after breastfeeding.
Breastfeeding self-efficacy assessment
时间窗: Post op 24 hour
After the interventions along with the Breastfeeding Self-Efficacy Scale, will be applied to all groups on post-operative day 0, at the 3rd hour, and at the 24th hour. The Breastfeeding Self-Efficacy Scale (Dennis and Faux, 1999) is a 33-item scale developed to assess how confident mothers feel about breastfeeding. All items in the scale have positive connotations. As a result of internal consistency analysis, items with a total-item correlation below 0.60 were removed, and a 14-item short form was created. The Cronbach's alpha value for this short form is 0.94. The scale is a 5-point Likert type, with scores ranging from 14 to 70, and a higher score indicates greater breastfeeding self-efficacy. The Turkish adaptation was carried out by Aluş-Tokat and Okumuş (2010), and the Cronbach's alpha value was found to be 0.86.
Breastfeeding evaluation
时间窗: Post op 24 hour
After the interventions, the LATCH Breastfeeding Charting System and Documentation Tool, will be applied to all groups on post-operative day 0, at the 3rd hour, and at the 24th hour. The LATCH Breastfeeding Diagnostic Tool, developed in 1986, is a tool created by adapting the APGAR score system in terms of its scoring method. This measurement tool was developed to make an objective diagnosis of breastfeeding, identify breastfeeding problems, create an educational plan, establish a common language among healthcare professionals, and be used in research (to determine breastfeeding success in longitudinal studies). The tool consists of five evaluation criteria, and the first letters of these criteria combine to form the acronym LATCH. Each item is evaluated between 0-2 points. The maximum score that can be obtained from the scale is 10. In Turkey, its reliability was studied by Yenal and Okumuş (2003), and and the Cronbach's alpha value was determined to be 0.95.
次要结局
未报告次要终点
研究者
Şeyma Çatalgöl
Dr
Uşak University