THE EFFECT OF WEB-BASED BREASTFEEDING COUNSELING

November 25, 2023 updated by: Ayşe Gül KOCA, Mersin University

THE EFFECT OF WEB-BASED BREASTFEEDING COUNSELING GIVEN TO MOTHERS ON FULL BREASTFEEDING AND BREASTFEEDING MOTIVATION AND PROBLEMS

This randomized controlled study evaluates the effect of Web-Based Breastfeeding Counseling given to mothers on breastfeeding exclusively with breast milk in the first 6 months, breastfeeding motivation and breastfeeding problems.The main hypotheses it aims to answer are:

  1. The web-based breastfeeding counseling given to the mothers in the experimental group is effective on the breastfeeding only for the first six months.
  2. The web-based breastfeeding counseling given to the mothers in the experimental group is effective on the breastfeeding motivation of the mothers.
  3. The web-based breastfeeding counseling given to the mothers in the experimental group is effective on the breastfeeding problems of the mothers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In the study, 66 mother will randomly assigned to web-based breastfeeding counseling/experimental group and control group. To the web-based breastfeeding counseling/experimental group (n =33), during the first 6 months after birth, they will be directed to the web-based breastfeeding consultancy website. On this page, mothers will receive counseling on breastfeeding (written, visual, audio materials and telephone counseling) from birth. On the other hand, no other intervention will be applied to the control group other than routine treatment and midwifery care. The primary outcome of the research is the effect of web-based breastfeeding counseling on the breastfeeding only for the first six months of mothers. The secondary outcome of the study is to determine the effect of web-based breastfeeding counseling on the breastfeeding motivation of the mothers. The tertiary outcome of the study is to determine the effect of web-based breastfeeding counseling on the breastfeeding problems of the mothers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Mersin, Turkey, 33343
        • Mersin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • treated at the relevant hospital
  • who volunteered to participate in the research
  • in the age range of 18-40
  • oriented to place, time and person
  • 37-42 weeks of pregnancy. between the weeks
  • having first pregnancy
  • having a healthy pregnancy
  • Those who do not have any health problems that prevent breastfeeding (HIV, drug use, etc.)
  • who is literate
  • able to use computer or smart phone
  • Those who do not have a communication barrier (not knowing Turkish, mental retardation, etc.)
  • with internet at home

Exclusion Criteria:

  • any health problem that prevents breastfeeding
  • having a baby with any health problem that prevents breastfeeding
  • who have a baby who was taken to the intensive care unit due to postpartum health problems
  • with multiple pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Web-based breastfeeding counseling/experimental group
The web-based breastfeeding counseling/experimental group (n =33) will be given the web-based breastfeeding counseling.
Other: The web-based breastfeeding counseling
To the web-based breastfeeding counseling/experimental group (n =33), during the first 6 months after birth, they will be directed to the web-based breastfeeding consultancy website. On this page, mothers will receive counseling on breastfeeding (written, visual, audio materials and telephone counseling) from birth. In addition, the Web-based breastfeeding counseling/experimental group will fill out data collection forms in the first 24 hours, 1st, 2nd, 4th and 6th months after delivery.
No Intervention: Control group
It will only take routine treatment and midwifery care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postpartum Breastfeeding Evaluation and Follow-up Form
Time Frame: Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum
In this form, which was created by the researchers to evaluate and monitor postpartum breastfeeding, using the literature, there are questions that evaluate situations such as "the way babies are fed, the status of giving additional nutrients other than breast milk, the mothers' breastfeeding problems, and the mother's desire to continue breastfeeding.
Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Breastfeeding Motivation Scale
Time Frame: Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum
It was developed by Kestler, Peleg et al (2015) and adapted into Turkish by Mızrak and Özerdoğan (2017). The scale consists of 24 items in total and consists of 5 sub-dimensions: "Integrated regulation" "intrinsic motivation and identified regulation", "introjected regulation - social approval", "introjected regulation - social pressure", and "external regulation - additional benefits".The Cronbach alpha value of the scale was found to be 0.855. Cronbach's alpha values for sub-dimensions vary between (0.846 - 0.670). The scale is in 4-point Likert type, and each item is scored between 1-4 (from 1 = "I strongly disagree" to 4 = "I totally agree"). The scale does not have a total score. The scores of the sub-dimensions are calculated by taking the average of the sub-dimension scores of the scale. As the score obtained from the scale sub-dimension increases, the motivation to breastfeed, which represents that sub-dimension, also increases.
Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum
Breastfeeding Problems Assesment Scale
Time Frame: Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum
It was developed by Wambach (1990), is a 30-item scale in order to determine the level of the problem experienced ("never happened" (1) to "unbearably happened" (5)). The total score of the scale varies between 18 and 90. A high score indicates that the severity of the problem has increased. The 18 items in the scale include mechanical concerns, process concerns, concerns about milk insufficiency , concerns about the udder and questions related to social concerns. The last 12 items of the scale evaluate whether breastfeeding is continued, whether formula is added, how often formula is given, and what are the breastfeeding difficulties related to the mother's decision to wean in case of early weaning. The Turkish validity and reliability of the scale was performed by Uyanık (2019) and he Cronbach's alpha value of the scale was found to be 0.77 for the sub-dimensions, and between 0.71-0.85.
Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mine YURDAKUL, Doctorate, Mersin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 25, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ayse Gul KOCA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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