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临床试验/NCT05673317
NCT05673317已完成不适用

A Technological Approach to Improved Breastfeeding Rates and Self-Efficacy: A Randomized Controlled Clinical Trial

Augusta University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年5月29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
40
试验地点
1
主要终点
Breastfeeding Self-Efficacy Score

研究概览

简要总结

To provide patients with easily accessible information in the form of a smartphone application regarding medically appropriate information about breastfeeding and to assess the impact this information has on women's breastfeeding rates and perception of self-efficacy (primary outcome).

详细描述

The benefits of breastfeeding for both mother and neonate have been well documented and extensively researched. Breastfeeding rates remain suboptimal despite known advantages including reduced lifetime risk of maternal ovarian cancer, more rapid return to pre-gestational weight, improvement in maternal/neonatal bonding, reduction in neonatal allergic/immunologic conditions. Both non-modifiable and modifiable factors affecting a mother's decision regarding breastfeeding have been identified. Modifiable factors include breastfeeding knowledge, self-efficacy, and confidence. Breastfeeding self-efficacy has been positively correlated with breastfeeding duration. There is a lack of local data on breastfeeding rates, duration, and self-efficacy in the Augusta University women's health population as well as a lack of documented improvement of these factors following educational programs. Our study aims to create a program that is easily accessible and available to our patient population in the form of a free application available on Apple devices capable of accessing the internet (e.g., i-phone, i-pad, etc.). This study will be a randomized controlled pilot study. The intervention group will have access to the application while the control group will not. Our hypothesis is that the application will improve breastfeeding rates, duration, and self-efficacy if offered to at the time of delivery or within the first week postpartum. This will be assessed by comparing initial self-efficacy survey results (within 1 week postpartum) with survey results at 4 to 6 weeks postpartum.

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 (Care Provider, Outcomes Assessor)

盲法说明

The participant cannot be blinded as they will be using the application.

The investigator cannot be blinded as they have to provide the application to the patient, teach them how to use it, and perform their surveys about the application use.

The outcomes assessor and care provider will be blinded.

入排标准

性别
Female
接受健康志愿者
是

入选标准

  • •Patients intending to breastfeed receiving prenatal care at Augusta University.
  • •No documented anatomic differences in mother's chest anatomy.
  • •Access to the internet via an Apple® device (such as i-phone or i-pad).
  • •Delivery at Augusta University Medical Center

排除标准

  • •Significant maternal intrapartum or postpartum complications (i.e., postpartum hemorrhage > 2000 mL, uterine inversion, retained products, ICU admission, postpartum psychosis).
  • •Infants admitted to neonatal intensive care unit >48 hours
  • •Pre-term deliveries prior to 37 weeks gestation
  • •Infants with cleft palate, or other palate/facial defects
  • •Patients without email access or internet access
  • •Patients without an Apple® device (i-phone, i-pad)
  • •Non-English speaker
  • •Patients unable to breastfeed secondary to contraindicated communicable disease (i.e.
  • •Patients unable to breastfeed secondary to contraindicated medications
  • •Patients of infants up for adoption

研究组 & 干预措施

Experiment Arm

Experimental

The participant will receive usual breastfeeding care such as counseling by her physician, access to lactation consults, nursing assistance in the hospital, access to our online resources. The participant will also receive the breastfeeding application at admission to labor and delivery or in the immediate postpartum period. The participant will be taught how to use the application, and will have access to the study to continue use throughout the duration of follow-up.

干预措施: "Breastfeeding at AU" Smartphone Application (Other)

Control Arm

No Intervention

The participant will receive usual breastfeeding care such as counseling by her physician, access to lactation consults, nursing assistance in the hospital, access to our online resources.

结局指标

主要结局

Breastfeeding Self-Efficacy Score

时间窗: 6 weeks

The breastfeeding self-efficacy short form is a validated, standardized form to assess participants' sense of breastfeeding self-efficacy.

次要结局

  • Breastfeeding rate(6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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