The Effect of Mindfulness-Based Stress Reduction on Maternal Perceived Milk Supply: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mindful Breastfeeding Scale (MIND-BFS)
研究概览
简要总结
The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) programme on breastfeeding self-efficacy, stress, depression, anxiety and breastfeeding awareness in women with perceived breast milk insufficiency.
详细描述
The aim of this study was to evaluate the effects of a mindfulness-based stress reduction (MBSR) programme on breastfeeding self-efficacy, stress, depression, anxiety and breastfeeding awareness in women with perceived breast milk insufficiency.
The study is designed as a single-blind, randomised controlled trial. It will be conducted between November 2024 and January 2025 at the Zeynep Kamil Women and Children's Diseases Education and Research Hospital.
Power analysis using G*Power showed that at least 35 samples would be sufficient for 2 groups with an effect size of 0.5, 95% power and 5% margin of error. Participants to be included in the groups were selected from the sample using a random sampling method with an equal distribution ratio (distribution ratio = 1:1).
Eligible women were randomised to the intervention group (n=35) and the control group (n=35). Women allocated to the intervention group received the MBSR programme. MBSR was scheduled for 4 weekly sessions of 30 minutes each. The control group received routine hospital care but no other intervention during this period.
The pre-test data for the study were collected by the researcher using face-to-face interviews, a personal information form with demographic questions and the measurement tools used in the study. After one week and at the end of 4 weeks, the same measurement tools were used to collect post-test data.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being between the ages of 18-35
- •37 weeks or more of gestation
- •Having given birth vaginally
- •University Health Application and Research Center, Gynaecology and Obstetrics Clinic
- •Having a single and healthy baby (no multiple pregnancy)
- •Having completed at least primary school
- •Being able to communicate in Turkish by phone using the WhatsApp application
- •The baby is with the mother
排除标准
- •Having a high-risk pregnancy
- •Having a medical condition or taking medication that prevents breastfeeding
- •Having a communication problems (vision, hearing, speech, language problems)
- •Having a psychiatric illness
- •There is an obstacle that prevents the baby from being with the mother or being in the neonatal intensive care unit
- •Having a condition/disease that prevents you from doing mindfulness practices (breathing exercises, body scanning)
研究组 & 干预措施
Experimental
Women assigned to the experimental group will receive mindfulness-based stress reduction training for 4 weeks.
干预措施: Mindfulness-based Stress Reduction (Behavioral)
Control
Women assigned to the control group will receive routine postpartum care services provided in the same hospital's outpatient clinics.
结局指标
主要结局
Mindful Breastfeeding Scale (MIND-BFS)
时间窗: Day 1, Day 7, Day 30 after delivery
The Mindful Breastfeeding Scale (MIND-BFS) is a 9-item measurement tool that evaluates awareness-based breastfeeding practices in the postpartum period. The scale is one-dimensional and was developed as a 5-point Likert type. Responses to the scale items vary from (1) Always to (5) Never. The total score to be obtained from the scale is scored between 9-45, and as the total score obtained from the scale increases, the awareness rate of breastfeeding also increases.
Breastfeeding Self-Efficacy Scale
时间窗: Day 1, Day 7, Day 30 after delivery
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. The Turkish validity and reliability of the Breastfeeding Self-Efficacy Scale Short form was performed by Aluş Tokat and Okumus in 2009. This scale assesses how competent mothers feel about breastfeeding. The scale consists of 14 items and includes a 5-point Likert-type evaluation consisting of Not sure at all: 1, Not very sure: 2, Sometimes I am sure: 3, I am sure: 4, Very sure: 5 options. 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.
Depression, Anxiety and Stress Scale (DASS-21)
时间窗: Day 1, Day 7, Day 30 after delivery
The scale consists of 21 items and three sub-dimensions. Each of the seven items that make up each sub-dimension of the scale measures depression, anxiety and stress. The DASS-21 scale is a four-point Likert-type scale and the items are evaluated between 0 and 3 (0 = not at all suitable for me, 1 = somewhat appropriate for me, 2 = usually suitable for me, 3 = completely suitable for me). There is no reverse item in the scale. The total scores of the scale range from 0 to 21 for each sub-dimension. In the validity and reliability study, the Cronbach-alpha coefficient was determined as 0.87 for the depression sub-dimension, 0.85 for the anxiety sub-dimension, and 0.81 for the stress sub-dimension. The Cronbach-alpha coefficient for the Turkish version of the Depression, Anxiety and Stress scale was determined as 0.88 for the depression sub-dimension, 0.80 for the anxiety sub-dimension and 0.87 for the stress sub-dimension
Multidimensional Scale of Perceived Social Support (MSPSS)
时间窗: Day 1, Day 7, Day 30 after delivery
MSPSS is a 12-item scale that measures the adequacy of social support. It consists of 3 subgroups that include items about family, friends and social support from a special person. It consists of 4 items for each group and each item is graded on a 7-item likert scale. A high total score indicates a high level of perceived social support.
Insufficient Milk Perception Scale
时间窗: Day 1, Day 7, Day 30 after delivery
The Insufficient Milk Perception Scale is a scale developed by McCarterSpaulding (2001) to measure mothers' beliefs about whether they produce sufficient milk. It consists of 6 questions. A minimum score of 0 and a maximum score of 50 can be obtained from this scale. A high score indicates that the mother's perception of adequate milk is high
次要结局
未报告次要终点
研究者
Leyla Kaya
Assoc. Prof.
Saglik Bilimleri Universitesi