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The Effect of Breastfeeding Support Provided Via Video-conferencing

2021年6月15日 更新者:Deniz Akyıldız、Kahramanmaras Sutcu Imam University

The Effect of Breastfeeding Support Provided Via Video-conferencing on Postpartum Anxiety, Breastfeeding Self-Efficacy and Neonatal Outcomes: A Randomized Controlled Trial

A randomized control trial was made to examine the effects of breastfeeding support given by the video-conferencing method in the early postpartum period on anxiety, breastfeeding self-efficiency, and newborn outcomes.

研究概览

研究类型

介入性

注册 (预期的)

78

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Kahramanmaraş
      • Kahramanmaras、Kahramanmaraş、火鸡、4600
        • 招聘中
        • Kahramanmaras Sutcu Imam University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

Infants;

  • Born between 37 and 42 weeks
  • Without severe congenital anomalies

Mothers;

  • A single live birth
  • Were 18 years of age or over
  • At least primary school graduate
  • Did not have a disease that prevents breastfeeding
  • Had internet access at home or on the phone
  • Could speak and understand the Turkish language.

Exclusion Criteria:

  • Situations that cause separation of mother and baby
  • Hospitalization of the baby in intensive care
  • Inability to answer 3 calls in a video call
  • They were determined as those who could not be reached during the home visit for the first and second follow

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Video-conferencing group
The mothers in the video-conferencing group were counseled via video-conferencing a total of six times (three times a week, at equal intervals) during the first 2 weeks after birth. Each interview was approximately 15-20 minutes. In video-conferencing sessions, the breastfeeding position, the mother's grasping the breast, the baby's latch-on, and sucking duration were observed. Mothers' questions were answered and solutions were offered for breastfeeding problems (sore nipple, engorgement, etc.).
No intervention
其他名称:
  • 控制组
无干预:Control group
The mothers in the control group were given usual care before discharge and no intervention was made after discharge.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The mean postpartum maternal anxiety level (mean ± SD)
大体时间:at 2 weeks and 4 weeks after delivery
The primary outcome of this study was the mean postpartum maternal anxiety level (mean ± SD) of the mothers at 2 weeks and 4 weeks after delivery. Maternal anxiety level was assessed using the Postpartum Specific Anxiety Scale. The scale comprises 51 items and 4 sub-dimensions. It means that those who score 73 and below on the scale have low postpartum anxiety levels, those who score between 74 and 100 have a medium level, and those who score 101 and above have a high level of anxiety.
at 2 weeks and 4 weeks after delivery
The mean breastfeeding self-efficacy level
大体时间:at 2 weeks and 4 weeks after delivery
The other main outcome of the study was the mean breastfeeding self-efficacy level (mean ± SD) measured with the Breastfeeding Self-Efficacy Scale Short Form. The scale is likert type and a total score between 14 and 70 is taken from the scale. The higher the score, the higher the breastfeeding self-efficacy.
at 2 weeks and 4 weeks after delivery

次要结果测量

结果测量
措施说明
大体时间
Neonatal outcomes-Newborn weight (g)
大体时间:at 2 weeks and 4 weeks after delivery
Newborn weight (g) was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Hypoglycemia of the newborn
大体时间:at 2 weeks and 4 weeks after delivery
Hypoglycemia of the newborn was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery.
at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Need for phototherapy
大体时间:at 2 weeks and 4 weeks after delivery
The need for phototherapy was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Respiratory morbidity
大体时间:at 2 weeks and 4 weeks after delivery
Respiratory morbidity was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
at 2 weeks and 4 weeks after delivery
Neonatal outcomes-illness requiring hospitalization
大体时间:at 2 weeks and 4 weeks after delivery
Illness requiring hospitalization was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Food intake other than breast milk
大体时间:at 2 weeks and 4 weeks after delivery
Food intake other than breast milk was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
at 2 weeks and 4 weeks after delivery
Neonatal outcomes-Neonatal death
大体时间:at 2 weeks and 4 weeks after delivery
Neonatal death was evaluated using the Follow-up Form at 2 weeks and 4 weeks after delivery
at 2 weeks and 4 weeks after delivery

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Betül Bay、Kahramanmaras Sutcu Imam University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年8月25日

初级完成 (预期的)

2021年9月30日

研究完成 (预期的)

2021年9月30日

研究注册日期

首次提交

2021年6月7日

首先提交符合 QC 标准的

2021年6月15日

首次发布 (实际的)

2021年6月18日

研究记录更新

最后更新发布 (实际的)

2021年6月18日

上次提交的符合 QC 标准的更新

2021年6月15日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Breastfeeding Support

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Video-conferencing group的临床试验

3
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