The Effect of Sensory Mindfulness Technique on Breast Milk, Maternal Well-Being, and Stress Levels in Mothers Whose Infants Are Undergoing Treatment in the Neonatal Intensive Care Unit and Are Breastfeeding With Expressed Breast Milk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Breast Milk Volume (mL)
研究概览
简要总结
Abstract Background: Breast milk is the optimal source of nutrition for infant growth and development and provides important physical and psychological benefits for mothers. Because many infants in the Neonatal Intensive Care Units (NICU) cannot be breastfed directly, mothers are required to express milk regularly; however, stress, anxiety, and depression may negatively affect milk production and the milk ejection reflex. This study aims to evaluate the effect of the sensory mindfulness intervention on breast milk volume, pumping duration, maternal well-being, stress levels, and cognitive and emotional mindfulness.
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
- None (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having an infant hospitalized in the neonatal intensive care unit
- •Expressing breast milk for the infant
- •Having a term newborn
- •Not having twins
- •Having no health condition that would prevent participation in the study
- •Being able to speak Turkish
- •Volunteering to participate in the research.
排除标准
- •Missing two or more intervention sessions
- •Leaving more than 5% of the questionnaire's incomplete
- •The newborn having a high risk of morbidity or mortality
- •The presence of a congenital malformation in the newborn
- •Undergoing a surgical procedure during the study period
- •Having a history of a physical or mental condition that could hinder participation or receiving psychological treatment before or during the intervention.
- •Termination criteria
- •The participant expressing a wish to withdraw from the study at any stage
- •Inability to complete the data collection protocol due to the end of the newborn's NICU hospitalization (discharge, transfer etc.)
- •Failure to maintain adherence to the research protocol (e.g., inability to complete planned milk expression records or scale administrations)
- •The development of a clinical condition during the study that prevented participation in the intervention or assessments (e.g., an acute health problem, treatment requiring sedation, or the need for intensive medical intervention)
- •A determination by the research team that continuation was not appropriate in terms of safety or data integrity.
研究组 & 干预措施
Control Group
Mothers assigned to the control group received routine care and standard breast milk pumping education only. Participants completed the Descriptive Information Form, WHO-5 Well-Being Index, Parental Stressor Scale: NICU (PSS:NICU), and Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Breast milk volume (mL) and pumping duration (minutes) were recorded at baseline and follow-up assessments conducted on Days 1, 2, 3, 4, 5, 6, 7, and 14. No mindfulness, relaxation, or sensory awareness intervention was provided.
Sensory Mindfulness Intervention
Mothers who met the eligibility criteria were randomly assigned to the sensory mindfulness intervention group. After providing informed consent, participants completed the Descriptive Information Form, WHO-5 Well-Being Index, Parental Stressor Scale: NICU (PSS:NICU), and Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). Mothers received standard training on breast milk pumping techniques and structured sensory mindfulness training. The intervention included exposure to the infant's scent using a beanie worn by the infant, visualization of the infant, viewing the infant's photograph, and positive thinking/sensory awareness exercises. Mothers performed the sensory mindfulness practice for approximately 8-10 minutes before each pumping session over a 14-day period. Breast milk volume (mL) and pumping duration (minutes) were recorded at baseline and follow-up assessments conducted on Days 1, 2, 3, 4, 5, 6, 7, and 14.
干预措施: Sensory Mindfulness Intervention (Behavioral)
结局指标
主要结局
Breast Milk Volume (mL)
时间窗: 2 WEEK
The amount of expressed breast milk (mL) measured during the study period. Milk volume was recorded separately for morning and evening pumping sessions using the Intervention Observation Form.
WHO (Five) Well-Being Index
时间窗: 1 months
A short and practical measure developed by the World Health Organization to assess individuals' general well-being and quality of life.
Parental Stressor Scale
时间窗: 1 months
Parent Stress Scale (Parental Stressor Scale: Neonatal Intensive Care Unit, PSS:NICU)
次要结局
- Pumping Duration (minutes)(2 WEEK)
- WHO-5 Well-Being Index Score(2 WEEK)
- Parental Stressor Scale: Neonatal Intensive Care Unit(2 WEEK)
- Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)(2WEEK)
研究者
Emel Yürük
Doctoral instructor
Cukurova University