跳至主要内容
临床试验/NCT07426185
NCT07426185已完成不适用

The Effect of Breastfeeding Counselling With Smartphone App on Breastfeeding Self-Efficacy, Breastfeeding Duration and Problems

Ege University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) total score

研究概览

简要总结

This randomized controlled study aimed to evaluate the effect of breastfeeding counselling delivered through a smartphone application on breastfeeding self-efficacy, breastfeeding duration, and breastfeeding-related problems among primiparous women in the postpartum period. A total of 60 women were allocated to either an intervention group receiving app-based counselling and motivational messages or a control group receiving routine postpartum care. Outcomes were assessed at multiple follow-up points up to six months postpartum using validated scales. The study investigated whether continuous mHealth-based support improves breastfeeding outcomes compared with standard care.

详细描述

Breastfeeding provides significant health benefits for both mothers and infants; however, low breastfeeding self-efficacy and insufficient professional support remain major barriers to sustained breastfeeding. Mobile health (mHealth) interventions offer accessible and continuous counselling opportunities, particularly during the early postpartum period when breastfeeding problems are most common. This study was designed to evaluate the effectiveness of a smartphone application-based breastfeeding counselling program in improving breastfeeding outcomes among primiparous women.

This randomized controlled trial was conducted at a Training and Research Hospital in Turkey between January 15, 2022, and March 1, 2022. A total of 100 primiparous women were initially randomized, and 60 participants completed the study. Women in the intervention group received access to a smartphone application that included evidence-based breastfeeding education videos, motivational messages, and an interactive "Ask Me" platform for continuous counselling. Motivational messages were sent daily during the first month and weekly from the second to the sixth month. The control group received routine postpartum care.

This study was registered retrospectively. Participant enrollment and data collection were completed before trial registration due to lack of awareness of the prospective registration requirement at the time of study initiation. The study was conducted with ethics committee approval and in accordance with institutional and ethical standards. The trial was registered to ensure transparency and public accessibility of the study protocol and results.

Breastfeeding self-efficacy, breastfeeding-related problems, and breastfeeding duration were assessed at multiple follow-up points up to six months postpartum using validated scales. The study aimed to determine whether continuous digital counselling improves maternal confidence, reduces breastfeeding problems, and increases breastfeeding continuation rates compared with standard care.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who agree to participate in the study,
  • Aged 18 years or older,
  • In the early postpartum period (first 24 hours),
  • Able to speak and understand Turkish,
  • Possessing a smartphone (ANDROID) and able to use it,
  • Who gave birth between 36 and 40 weeks of gestation,

排除标准

  • Women who have had a breast infection during pregnancy,
  • Women whose baby has an anomaly in the mouth region,
  • Women who have communication difficulties,
  • Women with a history of breast cancer,
  • Women who have given birth multiple times,
  • Women with multiple pregnancies,
  • Women with a premature baby,
  • Women whose baby has neonatal jaundice have been excluded from the study.

研究组 & 干预措施

Intervention group

Other

Participants received breastfeeding counselling via smartphone application including video education, motivational messages, and remote support for six months.

干预措施: Breastfeeding counselling via smartphone application (Behavioral)

Control Group

Other

Participants received routine postpartum breastfeeding care.

干预措施: routine postpartum breastfeeding care (Other)

结局指标

主要结局

Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) total score

时间窗: Baseline (first postpartum day), 14 days postpartum, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum

The Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) is a validated 14-item instrument that measures maternal confidence in breastfeeding. Total scores range from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy.

次要结局

  • Breastfeeding Problems Evaluation Scale total Score(Baseline (first postpartum day), 14 days postpartum, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum)
  • Breastfeeding duration (Breastfeeding ContinuationRate)(6monts postpartum)

研究者

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

Berna KAYA IBIS

PHD

Ege University

研究点 (1)

Loading locations...

相似试验