The Effect of Half Swaddle and Kangaroo Care Practıces Initiated in The Early Period In Preterm Infants on Breastfeeding, Mother-Infant Attachment, Maternal Sleep Quality and Postpartum Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- breastfeeding evaluated using the Breastfeeding Self-Efficacy Scale-Short Form
研究概览
简要总结
Aim: The aim of this study is to investigate the effect of half swaddle and kangaroo care practices initiated in the early period in preterm infants on breastfeeding, mother-infant attachment, maternal sleep quality and postpartum depression.
Design: The prospective, randomized controlled study
详细描述
The prospective, randomized controlled study was conducted on 160 mothers with premature babies whose age were between 18 and 49 randomly divided into four groups as 40 case group, 40 half swaddle group, 40 kangaroo care group, 40 half swaddle and kangaroo care group at the neonatal intensive care service and birth service of Trakya University Health Research and Application Center between September 2020 and March 2022.
In order to determine the number of samples, in order to test the difference in the effect size of 0.3326851 calculated between the groups based on the 1-month difference in the EPDS scores in the study of Herizchi et al. (2017), with 5% margin of error and 95% power, a total of n=40 from each group was used. It was calculated that the mothers who gave =160 preterm births should be included in the study.
N=160 samples of preterm infants were randomized with the help of ASS 11 (NCSS, LLC. Kaysville, Utah. www.ncss.com) computer program, HS group (n=40), KC group (n=40), HS+KC group. (n=40) and control (n=40) groups.
Data were collected using Survey Form, Edinburgh Postpartum Depression Scale (EPDS), Pittsburgh Sleep Quality Index (PSQI), Mother-to-Infant Bonding Scale (MIBS), Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), Latch Breastfeeding Diagnosis Measurement Form, Perception of Insufficient Milk Questionnaire (PIMQ). Data were evaluated using descriptive analyses, Mann Whitney U, Kruskal Wallis Test, Friedman S Test, Spearmen Correlation, multiple linear regression analysis.
Research data It was collected using the Survey Form, Edinburgh Postpartum Depression Scale (EPDS), Pittsburgh Sleep Quality Index (PSQI), Mother-to-Infant Bonding Scale (MIBS), Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), Latch Breastfeeding Diagnosis Measurement Form, Perception of Insufficient Milk Questionnaire (PIMQ).
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
- Double (Participant, 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 the mother;
- •Volunteer to participate in the research,
- •Over 18 years old,
- •Had a preterm birth (single birth less than 38 weeks),
- •After an uncomplicated pregnancy process, the delivery was completed by normal vaginal or cesarean delivery method,
- •Prepregnancy BMI <35,
- •Stable vital signs, For baby;
- •Birth weight below 2500 g,
- •Stable vital signs,
- •APGAR score of 7 and above,
- •Hospitalized for a minimum of 5 days,
- •Babies who are 2 weeks or more postpartum.
排除标准
- •For the mother;
- •Over 49 years old,
- •Full-term birth (38-42 weeks single birth),
- •Using cigarettes, alcohol and stimulants,
- •Pre-pregnancy BMI>35,
- •Working night shift,
- •Having received infertility treatment,
- •Having a chronic disease (such as hypertension, diabetes mellitus),
- •Experiencing severe depression, anxiety and stress,
- •Having any organic or non-organic disease that may cause cognitive impairment (such as Delirium, Dementia, Intellectual Retardation),
- •Mothers with serious maternal complications,
- •Birth weight of 2500 g and above,
- •APGAR score below 7,
- •Having serious neonatal complications,
- •Congenital malformation,
- •Hospitalized for a maximum of 5 days,
- •Babies under 2 weeks postpartum.
结局指标
主要结局
breastfeeding evaluated using the Breastfeeding Self-Efficacy Scale-Short Form
时间窗: change from before implamentation patent and 1st, 2nd, 3rd, and 6th months of practice.
): The BSES-SF was developed by Dennis (1999). Later, the short form of the scale was developed by Dennis (2003) by reducing it. The BSES-SF is a 14-item instrument developed to measure breastfeeding confidence. All the items are preceded by the statement "I can always" and are anchored by a five-point Likert-type scale, with 1 = not at all confident and 5 = always confident. All the items are presented positively and the scores are summed up to produce a final score ranging from 14 to 70, with the higher scores indicating better BSE. Turkish validity and reliability of the scale were done by Tokat and Okumuş (2013).
breastfeeding evaluated using the Perception of Insufficient Milk Questionnaire (PIMQ)
时间窗: change from before implamentation patent and 1st, 2nd, 3rd, and 6th months of practice.
Designed based on the conceptual model of McCarter-Spaulding and Kearney (2001), clinical experience, and literature, this six-question questionnaire was designed to measure the perception of insufficient milk in breastfeeding mothers. Turkish validity and reliability study was done by Gökçeoğlu. The first question is a ''yes'' or ''no'' question about whether them other perceives her milk as sufficient and other questions assess whether the mother perceives her milk as insufficient. Mothers rated these questions between 0 and 10, with ''0" meaning that her milk is perceived as completely insufficient, and ''10" meaning that her milk is perceived as completely sufficient. The lowest and highest scores possible on the scale are 0 and 50, respectively. The value of the total score indicates how high the score is and whether the perception of the amount of milk is sufficient.
mother infant attachment evaluated using the Mother-to-Infant Bonding Scale (MIBS)
时间窗: change from before implamentation patent and 1st, 2nd, 3rd, and 6th months of practice.
MIBS was developed by Taylor et al.12. The MIBS is a measurement tool that can be applied easily and quickly by the puerperal from the first day of the postpartum period and that allows the mother to express her feelings for her baby. This scale shows the relationship between the bond between mother and infant and the mother's mood during the early postpartum period. The MIBS is a four-point Likert-type scale consisting of eight items. Answers are scored between 0-3, the lowest score that can be obtained from the scale is 0 and the highest score is 24. High scores indicate a problem with mother-infant bonding. A Turkish validity and reliability study of the scale was conducted by Karakulak and Alparslan.
mother sleep quality evaluated using the Pittsburgh Sleep Quality Index (PSQI)
时间窗: change from before implamentation patent and 1st, 2nd, 3rd, and 6th months of practice.
PSQI is a self-reported screening and assessment questionnaire that details information on the type and severity of sleep quality and disorders within the last month. It was developed by Buysse et al. (20), and its validity and reliability study in Turkish was performed by Agargün et al. (21). PUKI evaluates sleep quality in the last month. 18 items and 7 components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, daytime dysfunction) are included in the scoring. Each item is evaluated over 0-3 points and the sum of 7 component points gives the total PUKI score. The total score ranges from 0 to 21, with higher scores indicating worsening sleep quality. A total PUKI score of ≤5 is considered "good sleep", and \>5 is considered "bad sleep".
breastfeeding evaluated using the Latch Breastfeeding Diagnosis Measurement Form
时间窗: change from before implamentation patent and 1st, 2nd, 3rd, and 6th months of practice.
It is a measurement tool developed by Jensen et al. (1994). The Turkish validity of the Latch Breastfeeding Diagnosis Measurement Form was performed by Yenal and Okumus (2003). The Latch Breastfeeding Diagnosis Measurement Form consists of the combination of the first letters of the English equivalent of the five evaluation criteria and is listed as follows: L (Latch on breast), A (Audible swallowing), T (Type of nipple), C (Comfort breast/nipple), H (Hold / Help). Each item in the scale is evaluated between 0-2 points. The lowest 0 and the highest 10 points are obtained from the scale. Total high score indicates the baby's sucking success.
postpartum depression evaluated using the Edinburgh Postnatal Depression Scale (EPDS)
时间窗: change from before implamentation patent and 1st, 2nd, 3rd, and 6th months of practice.
The scale was developed by Cox and Holden (1987). Adapted to Turkish by Engindeniz, Küey, and Kültür (1996). It is used to determine the risk for depression in the postnatal period and to measure the level and change of violence. It is a self-assessment scale. It is applied to postpartum women. It contains a total of 10 questions and measures depression. It provides a four-point Likert type measurement. The directive is at the beginning of the scale and subjects are asked to mark the substance most relevant to their situation when filling in the subjects. The total score of the scale is obtained by adding these item scores. As a result of the cut-off point scale study conducted in Turkey and it has ben calculated as 12/13.
次要结局
未报告次要终点
研究者
Burcu KUCUKKAYA
Research Assistant
Trakya University
