Web-based Breastfeeding CounselingNCT05950048
THE EFFECT OF WEB-BASED BREASTFEEDING COUNSELING
A study testing The web-based breastfeeding counseling in people with Web-based Breastfeeding Counseling, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Web-based Breastfeeding Counseling
- What is being tested?
- The web-based breastfeeding counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 25 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Web-based Breastfeeding Counseling
- Being tested
- The web-based breastfeeding counseling
- Keywords
- Breastfeeding counseling, Breastfeeding motivation, Web-based, Breast milk, Breastfeeding problems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The web-based breastfeeding counselingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-based breastfeeding counseling/experimental group | Experimental | The web-based breastfeeding counseling/experimental group (n =33) will be given the web-based breastfeeding counseling. Receives: Other: The web-based breastfeeding counseling |
| Control group | No intervention | It will only take routine treatment and midwifery care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum Breastfeeding Evaluation and Follow-up Form
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.
Measured: Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum
Secondary outcomes (2)
Breastfeeding Motivation Scale
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.
Measured: Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum
Breastfeeding Problems Assesment Scale
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.
Measured: Change from before implementation (within the first 24 hours postpartum) and 1st, 2nd, 4rd and 6th months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jan 2023
- Primary completion25 Nov 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Web-based Breastfeeding CounselingStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel, two-arm randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Gül KOCA, Mersin University
- Investigators
- Mine YURDAKUL, Doctorate, Study director, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950048
- Sponsor's protocol ID
- Ayse Gul KOCA
- Status last verified
- Nov 2023
- First submitted
- 8 Jul 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Koca AG, Yurdakul M. Impact of web based lactation support on exclusive breastfeeding, maternal motivation and breastfeeding challenges: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Feb 9;26(1):269. doi: 10.1186/s12884-026-08662-9.
PubMed 41664025
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF WEB-BASED BREASTFEEDING COUNSELING GIVEN TO MOTHERS ON FULL BREASTFEEDING AND BREASTFEEDING MOTIVATION AND PROBLEMS
- ClinicalTrials.gov ID
- NCT05950048
- Acronym / sponsor ID
- Ayse Gul KOCA
- Conditions
- Web-based Breastfeeding Counseling
- Keywords
- Breastfeeding counseling, Breastfeeding motivation, Web-based, Breast milk, Breastfeeding problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, parallel, two-arm randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Web-based breastfeeding counseling/experimental group | Experimental | Other: The web-based breastfeeding counselingThe web-based breastfeeding counseling/experimental group (n =33) will be given the web-based breastfeeding counseling. |
| Control group | No intervention | –It will only take routine treatment and midwifery care. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The web-based breastfeeding counselingTo 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. | Other | Web-based breastfeeding counseling/experimental group |
Primary outcome
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.
2 secondary outcomes
Breastfeeding Motivation Scale
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 41664025Koca AG, Yurdakul M. Impact of web based lactation support on exclusive breastfeeding, maternal motivation and breastfeeding challenges: a randomized controlled trial. BMC Pregnancy Childbirth. 2026 Feb 9;26(1):269. doi: 10.1186/s12884-026-08662-9.
Related trials for Web-based Breastfeeding Counseling
Not yet recruiting
The Effect of Web-Based Counselling on Breastfeeding Experiences and Infant Care Competence Among Mothers of Preterm Babies
Preterm Birth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mine YURDAKUL, Doctorate study director
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The web-based breastfeeding counseling in people with Web-based Breastfeeding Counseling, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05950048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.