Development of 'My Breastfeeding Guide' Mobile Nursing Application

NCT05901298 | Recruiting DMC

• 1 other identifier: SBF-HB-ETS-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The research was planned to develop the "My Breastfeeding Guide" mobile nursing application, which was developed based on Dennis' Breastfeeding Self-Efficacy Theory and Pender's Health Promotion Model, and to determine its effect on the postpartum breastfeeding process, breastfeeding self-efficacy, infant feeding and attachment. The research is in randomized controlled experimental and longitudinal (prospective) design. The research will be carried out with pregnant women who applied to Famagusta State Hospital Obstetrics and Gynecology Polyclinic and a pregnant polyclinic of a private hospital in Famagusta. Pregnant women who applied to Famagusta State Hospital Gynecology and Obstetrics Polyclinic and private hospital's pregnancy polyclinic and met the inclusion criteria of the study will constitute the population of the research. The research will be designed in two groups as the mobile nursing practice group (intervention) and standard care group (control) developed based on Dennis's Breastfeeding Self-Efficacy Theory and Pender's Health Promotion Model. By calculating the sample size in the research, 44 people in the intervention group and 44 people in the control group will reach a total of 88 people. Pregnant Identification Form, Maternal Information Form, Breastfeeding Self-Efficacy Short Form Scale (Postnatal Form), Antenatal Self-Efficacy Short Form Scale, Infant Nutrition Attitude Scale, Breastfeeding Rating Scale, Maternal Attachment Scale and Breastfeeding Self-assessment Form will be used to collect data. Statistical analyzes of the data obtained from the research will be made using the Statistical Package for the Social Science (SPSS) 20.0 package program. While evaluating the research data, frequency, percentage, mean, standard deviation, median, variance analysis from descriptive statistical methods will be used. For homogeneity test between intervention and control groups, the Chi-square test for categorical variables, Mann Whitney test for numerical variables, and sociodemographic variables (age, education status, employment status of himself and his spouse, income level, etc.) and whether the groups are similar in terms of some characteristics. U test will be used. The conformity of the scale scores to the normal distribution will be evaluated with the Shapiro-Wilk test. The results will be evaluated at the 95% confidence level, and the significance at the p\<0.05 level.

Conditions

Self Efficacy; Breast Feeding; Attachment

Keywords

Breastfeeding; Nurse; Mobile application; Self-efficiency

Outcome Measures

Primary Outcomes (8)

• Pregnant Introduction Form

  The Pregnant Introductory Form was created by the researcher using the literature. The form contains personal information and pregnancy information.

  Between 32nd - 42nd gestational week

• Mother Introductory Form

  The Mother Identification Form was created by the researcher using the literature. Form consists of a total of 15 questions, such as including information such as feeding the baby, giving a pacifier to the baby, giving a bottle to the baby, breastfeeding frequency in the first 24 hours.

  Postpartum first 24-48 hours,1st-6th week, 6th month

• Breastfeeding Self-Efficacy Short Form Scale (Postnatal Form)

  The Breastfeeding Self-Efficacy Scale was developed to evaluate the breastfeeding self-efficacy levels of mothers. The lowest score that can be obtained from the scale is 14, and the highest score is 70. A high score indicates that breastfeeding self-efficacy is high.

  Postpartum first 24-48 hours,1st-6th week, 6th month

• Antenatal Self-Efficacy Short Form Scale

  Antenatal Self-Efficacy Short Form Scale was developed to evaluate the breastfeeding self-efficacy levels of mothers in antenatal period. The lowest score that can be obtained from the scale is 14, and the highest score is 70. A high score indicates that breastfeeding self-efficacy is high.

  Between 32nd - 42nd gestational week

• Infant Nutrition Attitude Scale (BBTS)

  The Iowa Infant Feeding Attitude Scale (Iowa Infant Feeding Attitude Scale) evaluates women's attitudes towards breastfeeding and to predict breastfeeding duration as well as the choice of infant feeding method. The total attitude score ranges from 17 (reflecting a positive attitude in bottle feeding) to 85 points (reflecting a positive attitude in breastfeeding).

  Between 32nd - 42nd gestational week

• Breastfeeding Rating Scale (IBFAT)

  The Infant Breastfeeding Assesment Tool (IBFAT) evaluates the limitations of breastfeeding adequacy at each feeding, and the Turkish validity and reliability of the scale was performed by Çelik and Demirci in 2017. The scale consists of six questions and scores are made based on the answers of the mothers to the questions. Each question is evaluated between 0-3 points and the highest score is 12. The score range for effectively fed infants is 10-12 points.

  Postpartum first 24-48 hours,1st-6th week

• Maternal Attachment Scale

  The Maternal Attachment Scale (MBI) is a 26-item, four-point Likert-type scale developed by Mary E. Muller in 1994 to measure attachment with maternal love. Turkish validity and reliability of the scale was done by Kavlak and Şirin in 2009. The lowest score that can be obtained from the scale is 26, and the highest score is 104. A high score indicates high maternal attachment. It is recommended to apply the scale to mothers who have babies between one and four months postpartum.

  Postpartum 6th week

• Breastfeeding Self-Assessment Form

  The Breastfeeding Self-Assessment Form was created by the researchers on the basis of the Turkish Ministry of Health Breastfeeding Observation Form, in order for the mothers in the intervention group to evaluate their breastfeeding through the 'My Breastfeeding Guide' mobile nursing application. The form includes body position, baby's behavior, time spent sucking and sucking. This form does not have a scoring system. The purpose of using the form is for mothers to evaluate their own breastfeeding while using the mobile application.

  Postpartum first 24-48 hours,1st-6th week, 6th month

Study Arms (2)

Mobile Application

EXPERIMENTAL

"My Breastfeeding Guide" mobile nursing application, which was developed based on Dennis' Breastfeeding Self-Efficacy Theory and Pender's Health Promotion Model.

Device: My Breastfeeding Guide

Standart Care

NO INTERVENTION

Standard antenatal and postnatal care from health care providers.

Interventions

My Breastfeeding Guide DEVICE

Development of the content of the mobile nursing application had began with a literature review on breastfeeding, Dennis' Breastfeeding Self-Efficacy Theory and Pender's Health Promotion Model and after content is created. The mobile nursing application can be download via the Google Play Store® and the Apple Store®. The application consist of three parts. In the first part includes mother and baby information which is asked with scales and forms, the second part includes literature knowledge and the third section includes the expert consultation and blog section. Mothers receive notifications consisting of sentences every two days to increase their breastfeeding self-efficacy. The application web page can allow the mothers' information to be kept in the system.

Mobile Application

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 and over,
• Women who are in the last trimester of pregnancy (32nd gestational week and above),
• Women with singleton pregnancy,
• Women who do not have any health problems that may prevent breastfeeding,
• Women with smartphones with Android and iOS operating systems,
• Women who can access the Internet,
• There will be women who do not have literacy problems, mental disabilities and communication problems.

You may not qualify if:

• Women under 18 years of age,
• Women who are under the last trimester of pregnancy (32nd week of pregnancy),
• Women who do not speak Turkish,
• Women who own a smartphone with an operating system other than Android and iOS.

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Famagusta, Cyprus

RECRUITING

Related Publications (3)

• Doan TTD, Tran TC, Pham NM, Zhao Y, Dinh TPH, Hoai NX, Lee A, Binns C, Bui TTH. Designing and developing a mobile app (BeBo) in a randomized controlled trial study to promote breastfeeding among Vietnamese mothers. Int Breastfeed J. 2023 Jan 19;18(1):7. doi: 10.1186/s13006-023-00543-7.

  PMID: 36658643 RESULT

• Lewkowitz AK, Lopez JD, Carter EB, Duckham H, Strickland T, Macones GA, Cahill AG. Impact of a novel smartphone application on low-income, first-time mothers' breastfeeding rates: a randomized controlled trial. Am J Obstet Gynecol MFM. 2020 Aug;2(3):100143. doi: 10.1016/j.ajogmf.2020.100143. Epub 2020 May 17.

  PMID: 33345878 RESULT

• Meedya S, Win K, Yeatman H, Fahy K, Walton K, Burgess L, McGregor D, Shojaei P, Wheatley E, Halcomb E. Developing and testing a mobile application for breastfeeding support: The Milky Way application. Women Birth. 2021 Mar;34(2):e196-e203. doi: 10.1016/j.wombi.2020.02.006. Epub 2020 Feb 17.

  PMID: 32081557 RESULT

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Emine Temizkan Sekizler

CONTACT

+90 533 877 34 62; emine.temizkan@emu.edu.tr

Şenay Ünsal Atan

CONTACT

+90 505 730 31 40; senay.unsal.atan@ege.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Simple random sample selection will be made using the 'www.randomizer.org' program, and the pregnant women who accepted to participate in the study will be divided into intervention and control groups. To ensure randomization; Age, education level and number of births will be matched. The research will be designed in two groups as the mobile nursing practice group (intervention) and standard care group (control). In the study "The sample size was calculated at the 95% confidence level by using the "G. Power-3.1.9.2" program. As a result of the analysis, with considering the data loss, 10 people will be added to the groups and 44 people will be reached for the intervention group and 44 for the control group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: The research will be designed in two groups as the mobile nursing practice group (intervention) developed based on Dennis's Breastfeeding Self-Efficacy Theory and Pender's Health Promotion Model and standard care group (control).

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 13, 2023
• Study Start: December 15, 2023
• Primary Completion: October 15, 2024
• Study Completion: December 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CY (1)