- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05950048
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:
- The web-based breastfeeding counseling given to the mothers in the experimental group is effective on the breastfeeding only for the first six months.
- The web-based breastfeeding counseling given to the mothers in the experimental group is effective on the breastfeeding motivation of the mothers.
- 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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
66
Phase
- 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
- Name: Ayşe Gül KOCA, Bachelor
- Phone Number: +905425310908
- Email: ay.sem.yilmaz01@gmail.com
Study Locations
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Mersin, Turkey, 33343
- Mersin University
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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
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 |
Intervention / Treatment |
---|---|
Experimental: Web-based breastfeeding counseling/experimental group
The web-based breastfeeding counseling/experimental group (n =33) will be given 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.
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What is the study measuring?
Primary Outcome Measures
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
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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.
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Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum
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Secondary Outcome Measures
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.
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Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum
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Breastfeeding Problems Assesment Scale
Time Frame: Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum
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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.
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Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
January 1, 2023
Primary Completion (Actual)
November 25, 2023
Study Completion (Actual)
November 25, 2023
Study Registration Dates
First Submitted
July 8, 2023
First Submitted That Met QC Criteria
July 14, 2023
First Posted (Actual)
July 18, 2023
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 25, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID 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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