The Effect of Intermittent Kangaroo Care in the Early Postpartum Period to Primiparous Mothers on Breastfeeding Success and Perception of the Maternal Role
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- LATCH Breastfeeding Assessment Tool
研究概览
简要总结
Purpose: This is a randomized controlled trial designed to investigate the effects of Intermittent Kangaroo Mother Care (KMC) in the early postpartum period to primiparous mothers on breastfeeding success and the perception of the maternal role.
Methodology and Sample:
Setting and Period: The study will be conducted at the Bucak State Hospital Delivery Unit between June 2025 and June 2026.
Sample Size: Based on G*Power analysis (alpha=0.05, power=80%, effect size d=0.548), a total of 108 mothers will be included, accounting for a 10% potential attrition rate. Participants will be assigned to groups using the sealed envelope method and randomization via www.random.org.
Intervention:
Experimental Group: Following routine care, the newborn will be placed in a "chest-to-chest" position on the mother's bare chest for intermittent Kangaroo Care. Intermittent KMC will be maintained for 24 hours, during which breastfeeding attempts will be supported.
Control Group: Mothers and newborns will receive only the hospital's routine care (standard skin-to-skin contact and breastfeeding support).
Data Collection Tools:
Personal Information Form, Semantic Differential Scale-Myself as a Mother (to measure maternal role perception), LATCH Breastfeeding Assessment Tool (to evaluate breastfeeding success).
详细描述
Intervention Protocol:
Experimental Group: In addition to routine delivery care, newborns will receive Kangaroo Mother Care (KMC). The newborn, wearing only a diaper and a hat, will be placed in an upright "chest-to-chest" position on the mother's bare chest. The infant's head will be maintained in a neutral physiological position, and the back will be covered with a blanket. The first application was performed under the researcher's supervision to ensure that the mothers were performing kangaroo care correctly. Mothers were provided with kangaroo care for 60 minutes (WHO, 2025b) after each feeding during the first 24 hours after birth. Mothers performed their first kangaroo care session with the researcher's assistance and subsequent sessions under the researcher's supervision. Mothers breastfed their babies every 2-3 hours and then provided kangaroo care.
Control Group: Participants will receive the standard hospital protocol (routine skin-to-skin contact immediately after birth and standard neonatal care). No additional KMC intervention will be applied by the study team.
Data Collection and Measurement Points:Data collection will be conducted at two specific time points to evaluate the effectiveness of the intervention:Baseline (0 Hour): Immediately following the first breastfeeding attempt (within the first hour postpartum), the LATCH Breastfeeding Assessment Tool and Semantic Differansial Scale will be administered to both groups to establish baseline breastfeeding success and mathernal role.Post-Intervention (24th Hour): At the end of the 24th hour postpartum, the LATCH tool will be re-administered to evaluate the change in breastfeeding success. Additionally, the Semantic Differential Scale-Myself as a Mother will be administered at this time point to compare maternal role perception between the two groups.
Statistical Analysis
The normality of the data will be assessed using the Skewness and Kurtosis coefficients. For Breastfeeding Success: A Two-Way Mixed ANOVA will be used to analyze the interaction between "Group" (Experimental vs. Control) and "Time" (0 vs. 24 hours).For Maternal Role Perception: Since this variable is measured only at the 24th hour, an Independent Samples t-test (or Mann-Whitney U test, depending on normality) will be used for inter-group comparison.All analyses will be performed using SPSS 25.0 with a significance level of p < 0.05.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For mothers:
- •It must be the mother's first birth,
- •Birth must have been vaginal,
- •The mother must be healthy,
- •The mother must voluntarily participate in the study,
- •The mother must not have any communication-impairing conditions (language, cognitive problems, etc.),
- •For babies:
- •Birth weight must be between 2500-4000 grams;
- •The newborn must be healthy,
- •Exclusively breastfeeding,
- •The newborn must be at term gestation (38-42 weeks),
- •The newborn's Apgar score at 1 and 5 minutes must be above 7,
- •The newborn must not have any health problems that could affect breastfeeding (cleft palate, cleft lip, esophageal atresia, etc.).
排除标准
- 未提供
研究组 & 干预措施
Kangaroo
Mothers in this group will receive intermittent Kangaroo Mother Care (chest-to-chest contact) for 24 hours postpartum.
干预措施: Kangaroo Mother Care (Behavioral)
Control
Mothers in this group will receive standard hospital postpartum care protocols, including routine skin-to-skin contact and breastfeeding support.
结局指标
主要结局
LATCH Breastfeeding Assessment Tool
时间窗: 8 month
Developed by Deborah Jehsen and Sheila Wallace in 1993 to assess breastfeeding, it consists of five parameters, each item scored between 0 and 2 points. The highest possible score on the scale is 10, and the lowest is 0. The validity and reliability of the LATCH Breastfeeding Assessment Tool in Turkey was determined by Yenal and Okumuş in 2003, and it was found to be valid and reliable for the Turkish population. The validity and reliability coefficient of the LATCH scale is alpha 0.82. The scale, consisting of 5 evaluation criteria, is formed by combining the first letters of the English words LATCH. The criteria are as follows; L: Latch on breast A: Audible swallowing T: Type of nipple C: Comfort breast/nipple. H: Baby holding position
Semantic Difference Scale - Self-Assessment as a Mother
时间窗: 8 month
Developed by Walker et al. (1986), this scale was designed to measure the evaluation dimensions of the concept of "self-assessment as a mother." The adaptation of the scale to Turkish society was done by Çalışır (2003). The scale consists of 11 pairs of opposing adjectives, distributed among 22 items. Each adjective pair is scored from 1 to 7. Three items (3, 7, 8) are evaluated using a reverse scoring system to prevent biased scoring by participants. A high total score on the scale indicates a positive self-assessment of motherhood (Walker et al., 1986). While Walker found the internal consistency coefficient to be between 0.81-0.85, Çalışır found the Cronbach Alpha internal consistency coefficient to be between 0.73-0.74 (Çalışır, 2003).
次要结局
未报告次要终点
研究者
Gamzegül ALTAY
Assistant Professor
Recep Tayyip Erdogan University