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临床试验/NCT05543902
NCT05543902已完成不适用

The Effects of the Breastfeeding Problems Management Model (BPMM) on Breastfeeding Problems, Breastfeeding Motivation and Breastfeeding Success: A Randomized Clinical Trial

Cukurova University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Breastfeeding Experience Scale (BES)

研究概览

简要总结

This randomized controlled interventional study was conducted with 50 women (25 intervention and 25 control). While the intervention group received an eight-week postpartum education and care according to the Breastfeeding Problems Management Model (BPMM) under the leadership of a nurse, the control group received routine care. CONSORT checklist was used to report the study.The women in the intervention group were provided with nursing interventions according to the BPMM by the researcher. The women in standard care group were not provided with any interventions by the researcher.

详细描述

This study was conducted as a randomized controlled trial to determine the effects of the Breastfeeding Problems Management Model (BPMM) on breastfeeding problems, breastfeeding motivation and breastfeeding success.

Research hypotheses H0: Mothers in the intervention and control group H01: Demonstrate no differences in terms of their "LATCH Assessment Tool" total mean scores.

H02: Demonstrate no differences in terms of their "Breastfeeding Motivation Scale" total mean scores.

H03: Demonstrate no differences in terms of their "Breastfeeding Experience Scale" total mean scores.

H1: Mothers in the intervention and control group H11: Demonstrate differences in terms of their "LATCH Assessment Tool" total mean scores.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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 aged between 18 and 35
  • •having vaginal delivery in the 37th gestational week or later
  • •being primiparous
  • •having a single and healthy fetus
  • •having graduated at least from a primary school
  • •living in Adana city center
  • •being able to communicate on the phone.

排除标准

  • •having no high-risk pregnancy
  • •having no medical diseases preventing breastfeeding
  • •having no communication problems
  • •having no psychiatric diseases
  • •not being a health professional
  • •having no health professional relatives to provide support in the postpartum care.
  • •Criteria for being excluded from the study:
  • •admission of the newborn to the intensive care
  • •development of postpartum psychological problems in the mother (maternity blues, depression)
  • •mother's changing city during postpartum follow-ups.

研究组 & 干预措施

Intervention group: Breastfeeding Problems Management Model (BPMM)

Experimental

The women in the intervention group were provided with nursing interventions according to the BPMM by the researcher. LATCH (pre-test) was administered before discharge from the hospital; women were given the education booklet; and their contact information was recorded. After discharge from the hospital, the women were called by phone in the 1st, 2nd, and 6th weeks, BES was read, and the scale was filled in by the researcher based on the women's responses. Women who were found to experience breastfeeding problems in these phone calls were provided with consultancy and home visits. In the 8th week, home visits were done and the education was repeated. The women were administered the BES, LATCH (post-test), and BMS.

干预措施: Breastfeeding Problems Management Model (BPMM) (Behavioral)

No Intervention: Standard care group

No Intervention

The women in standard care group were not provided with any interventions by the researcher. They were provided with standard care at the hospital. Before discharge from the hospital, the LATCH (pre-test) was administered and women's contact information was recorded. After discharge from the hospital, the women were called by phone in the 1st, 2nd, and 6th weeks. BES were read on the phone, and the scale was filled in by the researcher based on the women's responses. Home visits were performed in the 8th week, and the women were administered the BES, LATCH (post-test), and BMS

结局指标

主要结局

Breastfeeding Experience Scale (BES)

时间窗: Change in breastfeeding problems by 1st, 2nd, 6th and 8th weeks

The original scale is responded on a 5-point scale and is composed of 2 parts, 5 sub-scales, and 30 items. Turkish reliability and validity of the scale were performed by Uyanık and Çeber Turfan in 2019, and Cronbach's alpha coefficient was found 0.776. Scores to be obtained from the scale range between 18 and 90, with higher scores indicating higher severity of breastfeeding problems. BES was reported to be a valid tool for the Turkish Society.

次要结局

  • The LATCH Assessment Tool(Change in 1th and 8th weeks breastfeeding succes level.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zehra ÇERÇER

Principal Investigator

Cukurova University

研究点 (1)

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