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Completed

NCT Number: NCT07426185

Smartphone-Based Breastfeeding Counselling Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bakırçay University Çiğli Training and Research Hospital

Izmir, 35665, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,

Exclusion criteria

  • 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.

Treatment and study plan

Breastfeeding counselling via smartphone application

Behavioral

Video education,motivational messages and remote support for six months.

routine postpartum breastfeeding care

Other

Standart postpartum breastfeedingcare provided by hospital staff.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Breastfeeding Problems Evaluation Scale total Score

    Time frame: Baseline (first postpartum day), 14 days postpartum, 6 weeks postpartum, 3 months postpartum, and 6 months postpartum

    The Breastfeeding Problems Evaluation Scale is used to assess the severity of difficulties experienced by mothers related to breastfeeding. Total scores range from 18 to 90, with higher scores indicating greater severity of breastfeeding problems.

  2. Breastfeeding duration (Breastfeeding ContinuationRate)

    Time frame: 6monts postpartum

    Breastfeeding duration was assessed as the proportion of mothers who continued any breastfeeding at 6 months postpartum. Continuation of breastfeeding was determined based on maternal self-report during follow-up. Higher proportions indicate longer breastfeeding duration

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Acronym: Breastfeeding

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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