NCT05781477

Brief Summary

The goal of the study was to investigate effect of breastfeeding training program and nurse-led breastfeeding online counselling system (BMUM) on mothers' breastfeeding self-efficacy, breastfeeding attitudes, breastfeeding problems and postpartum depression we hypothesized that there would be differences between BG and CG groups in terms of breastfeeding self-efficacy, breastfeeding problems, postpartum depression and breastfeeding frequency. This was a randomized controlled trial. Participants were randomly assigned to the breastfeeding group (BG; n = 36), or control group (CG; n = 36). Control group will receive only standart care breastfeeding group will receive standart care and web based breastfeeding support. Breastfeeding attitudes, infant feeding attitude breastfeeding problems and postpartum depression will assessment. The assesment point will be 32-37 gestational week, postpartum 1st day, 1st week, 3 months, and 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

June 20, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 23, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

March 1, 2023

Last Update Submit

March 10, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Breastfeeding Self efficacy change on five points between groups

    Breastfeeding Self efficacy short form scale will use to assessment breasfeeding self efficacy. Total scores vary from 14 to 70, with higher scores indicating greater self-efficacy

    32-37 weeks 1st. day 1. week 3rd months 6th months

  • Infant feeding attitude change on five points between groups

    Iowa Infant Feeding Attitude Scale (IIFAS) will use to assessment infant feeding attitude Higher scores indicate a more favorable attitude toward newborn feeding

    32-37 weeks 1st. day 1. week 3rd months 6th months

  • Postpartum depression change on four points between groups.

    Edinburgh Postnatal Depression Scale (EPDS) will use to assesment postpartum depression. The total score ranges from 0 to 30, with higher scores suggesting a higher level of depression symptoms.

    1st. day 1st. week 3rd months 6th months

  • breast problems between two groups on 1 st week

    breast problem will assesment with breastfeeding problems questionnaire. number and percent will use to evaluate.

    1st week

Study Arms (2)

Bmum GROUP

EXPERIMENTAL

Mothers in this group were given supportive breastfeeding support with web based

Behavioral: Bmum supportive system

control group

NO INTERVENTION

Mothers in the control and intervention groups were given standard care based on the Baby-Friendly Hospital Intervention Standard.

Interventions

Bmum is a web-based online tracking system that aims to improve positive attitude about breastfeeding

Bmum GROUP

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old,
  • Primipara with a singleton pregnancy
  • and 37-weeks of gestation,
  • Willingness to participate in the workshop program

You may not qualify if:

  • Having a chronic illness
  • Having pre-term labor or an abnormal fetal screening
  • Had a psychiatric disorder or anxiety disorder
  • Having any other high-risk complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kastamonu University

Merkez, Kastamonu, 37150, Turkey (Türkiye)

Location

Şahika Şimşek Çetinkaya

Merkez, Kastamonu, 37150, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD,Dr.

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 23, 2023

Study Start

June 20, 2020

Primary Completion

November 20, 2020

Study Completion

July 15, 2022

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations