NCT05998681

Brief Summary

Objective: This study aims to investigate the effectiveness of education on breastfeeding and basic maternal-neonatal care and mobile message support given to primiparous women in the postpartum period on breastfeeding and motherhood experiences. Methods: This prospective randomized controlled study was conducted in a hospital located in a city in Turkiye, with 130 primiparous patients in the postpartum period (65 individuals in the experimental group and 65 individuals in the control group). Participants in the experimental group were provided with education on "Breastfeeding and Basic Maternal-Neonatal Care" at the hospital and mobile messages were sent with the same content as education program for 6 weeks after discharge.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 9, 2023

Last Update Submit

August 17, 2023

Conditions

Keywords

primiparbreastfeedingeducationself-efficacyattitudesatisfaction

Outcome Measures

Primary Outcomes (1)

  • Breastfeeding Self-Efficacy Scale (BSES)

    The BSES is a 33-item scale developed by Dennis and Faux in order to evaluate how competent mothers feel about breastfeeding. Later, in 2003, a 14-item short form of the scale was developed. The short form is easier to administer and accurately assesses breastfeeding self-efficacy. The BSES is a 5-point Likert-type scale, with each item rated from 1 (never sure) to 5 (always sure). The minimum score that can be obtained from the scale is 14, and the maximum score is 70. High scores indicate high breastfeeding self-efficacy.

    Change inbreastfeeding self-efficacy levels at 6 weeks

Secondary Outcomes (2)

  • IOWA-Infant Feeding Attitude Scale (IIFAS)

    Change in attitudes towards breastfeeding at 6 weeks

  • Being a Mother Scale (BaM-13)

    Change in satisfaction with the "motherhood" experience levels at 6 weeks

Study Arms (2)

Breastfeeding and Basic Maternal-Neonatal Care and mobile messages group

EXPERIMENTAL

In the study, education on "Breastfeeding and Basic Maternal-Neonatal Care" was given to the women in the experimental group within the first 24 hours after the birth, and the training topics were sent as a mobile message for 6 weeks after the birth. Education on "Breastfeeding and Basic Maternal-Neonatal Care" was given in 2 postpartum sessions. In the first session, breastfeeding education was given to women in practice, together with the first postpartum breastfeeding. At the beginning of the second session, breastfeeding training was repeated and then Basic Maternal-Neonatal Care training was given. The first session was given at the first breastfeeding time, and the second session was given between 20-24 hours after birth. Each session lasted approximately 20-25 minutes. In order to solve the problems of the mothers, questions, and answers were made before discharge, and breastfeeding of the mothers was observed.

Other: Breastfeeding and Basic Maternal-Neonatal Care and mobile messages

Routine checks

NO INTERVENTION

The researchers applied no initiative to the control group, and the women in the control group solely had the routine checks. The women in the control group filled out all pretest forms(A sociodemographic questionnaire including questions about age, educational level, employment, income level, whether the pregnancy was planned and the gender of the baby, as well as the personal phone numbers of the women, Breastfeeding Self-Efficacy Scale (BSES), IOWA-Infant Feeding Attitude Scale (IIFAS), and Being a Mother Scale (BaM-13) . The BSES, IIFAS, and BaM-13 were re-administered to all participants at postpartum 6 weeks as post-tests. In addition, the method by which the participants continued to feed their babies, their use of bottles or pacifiers, and their nipple problems were recorded in the form created by the researchers. Post-test data were collected by the researchers by contacting the participants by phone.

Interventions

Participants in the experimental group were provided with education on "Breastfeeding and Basic Maternal-Neonatal Care" at the hospital and mobile messages were sent with the same content as education program for 6 weeks after discharge.

Breastfeeding and Basic Maternal-Neonatal Care and mobile messages group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen in the first 24 hours after the birth
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primiparous;
  • aged ≥18 years;
  • having a healthy newborn;
  • participants who did not have an obstacle to postpartum breastfeeding and agreed to participate in the study

You may not qualify if:

  • Unable to communicate in Turkish
  • Those with diagnosed psychological health problems will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Sabanci Baransel

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast FeedingBehaviorPersonal Satisfaction

Interventions

Lactation

Condition Hierarchy (Ancestors)

Feeding Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This study was designed as a randomized controlled trial
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: This study was designed as a randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 21, 2023

Study Start

October 1, 2022

Primary Completion

December 1, 2022

Study Completion

June 30, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations