BreastfeedingNCT05340842
Evaluation of the Effects of Simulation Based Breastfeeding Training
A study testing simulation training group in people with Breastfeeding and Education, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study is a randomized controlled experimental study conducted to determine the effect of applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal period on the success of women in breastfeeding, their self-efficacy perception regarding breastfeeding and their attitude towards and… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Education
- What is being tested?
- simulation training group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 1 Mar 2020
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 32-36 between gestational weeks Primigravida No systemic/chronic disease Planning to breastfeed Who has not received a planned breastfeeding training before Can speak and understand Turkish Pregnant women who agreed to participate in the study were included.
Who cannot join
- Breastfeeding contraindications Having a high-risk pregnancy Preterm delivery (before 37 weeks of gestation) Having a health condition that prevents breastfeeding in the newborn after birth Having mental disability and serious mental disorder Women with multiple pregnancies were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Simulation Based Breastfeeding Training on Women' Breastfeeding Success, Breastfeeding Self Efficacy, Breastfeeding Attitude and Knowledge
This study is a randomized controlled experimental study conducted to determine the effect of applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal period on the success of women in breastfeeding, their self-efficacy perception regarding breastfeeding and their attitude towards and knowledge of breastfeeding.
Read the detailed description
This study is a randomized controlled experimental study conducted to determine the effect of applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal period on the success of women in breastfeeding, their self-efficacy perception regarding breastfeeding and their attitude towards and knowledge of breastfeeding. The research was carried out with the participation of two groups. In this context, applied breastfeeding training with LSM was given to pregnant women in the intervention group (simulation training group, n=64) during antenatal period, and standard training-video training under the hospital protocol (video training group, n = 64) was provided to pregnant women in the control group. Then, breastfeeding success, breastfeeding self efficacy, attitude and knowledge levels regarding breastfeeding were evaluated in the postnatal period. The data of the research were collected through Participant Description Questionnaire, LATCH Assessment Tool, Breastfeeding Attitude and Knowledge Questionnaire, Breastfeeding Self efficacy Scale and Postnatal Period Follow-up Questionnaire. In addition, LSM was employed in the implementation for the simulation training group. Research data were analyzed by using SPSS 23.0 statistics program.
- Conditions
- Breastfeeding, Education
- Being tested
- simulation training group
- Keywords
- antenatal period, simulation based breastfeeding training
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation training groupOther
In this study, applied breastfeeding training with Lactation Simulation Model was given to pregnant women in the intervention group (simulation training group, n=64) during antenatal period
| Study group | Role | What they receive |
|---|---|---|
| Simulation training experiment group | Experimental | In this training, the researcher firstly explained breastfeeding by wearing the Lactation Simulation Model on himself and showing it practically on himself.
Afterwards, the model was dressed on the pregnant woman and the pregnant woman was given one-on-one breastfeeding practice.
In this process, all questions of the pregnant woman were answered by the researcher. Receives: Other: simulation training group |
| Control group | No intervention | At this stage, the standard video screening prepared for breastfeeding education within the scope of the hospital protocol was shown to the pregnant woman by the researcher with a tablet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LATCH Breastfeeding Diagnostic and Assessment Scale
LATCH consists of the combination of the first letters of the English equivalent of the five criteria defined above. Each item is evaluated between 0-2 points. The lowest score that can be obtained from the entire scale is 0 and the highest score is 10. The scale has no breakpoints. The low score on the scale indicates the need for active intervention, support and follow-up after discharge in breastfeeding. The higher the LATCH Breastfeeding Diagnosis and Evaluation Scale score, the higher the success of breastfeeding. Cronbach's alpha value was found to be 0.95 in the study in which the Turkish validity and reliability of the scale was carried out.
Measured: The scale was filled twice, with an average of two hours, in the first 24 hours after delivery, when the mother was free of pain and felt well.
Secondary outcomes (2)
Breastfeeding Attitude and Knowledge Questionnaire
This form was created by researchers in line with the literature in order to determine the attitudes and knowledge levels of pregnant women towards breastfeeding.In the form, there are a total of 20 statements, 10 statements questioning the level of knowledge about breastfeeding and 10 statements questioning the attitude towards breastfeeding. Each statement in the form is marked as "True", "Wrong", "I don't know" according to the attitude and knowledge level of the people. In the evaluation of the form, correct answers were given as "1", "I don't know" or wrong answers were given "0" points. The lowest score that can be obtained from the entire form is 0 and the highest score is 20. The Cronbach's alpha value of the attitude and knowledge evaluation form regarding breastfeeding was found to be 0.60 in the antenatal period and 0.75 in the postnatal period. A high score on the form indicates a high level of positive attitude and knowledge about breastfeeding.
Measured: It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
Breastfeeding Self-Efficacy Scale-Short Form
Breastfeeding Self-Efficacy Scale consists of 14 items. The lowest score that can be obtained from the entire scale is 14 and the highest score is 70. A high score from the scale indicates a high perception of breastfeeding self-efficacy. This scale can be applied both in the antenatal and postnatal periods. The difference of the antenatal form of the scale from the postnatal form is that the phrase "future tense" is used in the scale items. In the original study of the scale, the Cronbach's alpha value of the antenatal form was 0.87, and the Cronbach's alpha value of the postnatal form was 0.86.
Measured: It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jun 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamide Aslan, Marmara University
- Investigators
- Hamide Arslan Tarus, Res. Asist., Principal investigator, Marmara UniversityGonul Kurt, Assist. Prof, Study director, Gulhane Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340842
- Sponsor's protocol ID
- 16214662/050.01.04/30
- Status last verified
- Dec 2024
- First submitted
- 4 Apr 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Simulation Based Breastfeeding Training on Women' Breastfeeding Success, Breastfeeding Self Efficacy, Breastfeeding Attitude and Knowledge
- ClinicalTrials.gov ID
- NCT05340842
- Acronym / sponsor ID
- 16214662/050.01.04/30
- Conditions
- Breastfeeding, Education
- Keywords
- antenatal period, simulation based breastfeeding training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 22 Apr 2022 (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 study is a randomized controlled experimental study conducted to determine the effect of applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal period on the success of women in breastfeeding, their self-efficacy perception regarding breastfeeding and their attitude towards and knowledge of breastfeeding.
Detailed description
This study is a randomized controlled experimental study conducted to determine the effect of applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal period on the success of women in breastfeeding, their self-efficacy perception regarding breastfeeding and their attitude towards and knowledge of breastfeeding. The research was carried out with the participation of two groups. In this context, applied breastfeeding training with LSM was given to pregnant women in the intervention group (simulation training group, n=64) during antenatal period, and standard training-video training under the hospital protocol (video training group, n = 64) was provided to pregnant women in the control group. Then, breastfeeding success, breastfeeding self efficacy, attitude and knowledge levels regarding breastfeeding were evaluated in the postnatal period. The data of the research were collected through Participant Description Questionnaire, LATCH Assessment Tool, Breastfeeding Attitude and Knowledge Questionnaire, Breastfeeding Self efficacy Scale and Postnatal Period Follow-up Questionnaire. In addition, LSM was employed in the implementation for the simulation training group. Research data were analyzed by using SPSS 23.0 statistics program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulation training experiment group | Experimental | Other: simulation training groupIn this training, the researcher firstly explained breastfeeding by wearing the Lactation Simulation Model on himself and showing it practically on himself. Afterwards, the model was dressed on the pregnant woman and the pregnant woman was given one-on-one breastfeeding practice. In this process, all questions of the pregnant woman were answered by the researcher. |
| Control group | No intervention | –At this stage, the standard video screening prepared for breastfeeding education within the scope of the hospital protocol was shown to the pregnant woman by the researcher with a tablet. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 32-36 between gestational weeks Primigravida No systemic/chronic disease Planning to breastfeed Who has not received a planned breastfeeding training before Can speak and understand Turkish Pregnant women who agreed to participate in the study were included.
Key exclusion criteria (1 listed)
- Breastfeeding contraindications Having a high-risk pregnancy Preterm delivery (before 37 weeks of gestation) Having a health condition that prevents breastfeeding in the newborn after birth Having mental disability and serious mental disorder Women with multiple pregnancies were excluded from the study.
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 |
|---|---|---|
| simulation training groupIn this study, applied breastfeeding training with Lactation Simulation Model was given to pregnant women in the intervention group (simulation training group, n=64) during antenatal period | Other | Simulation training experiment group |
Primary outcome
LATCH Breastfeeding Diagnostic and Assessment Scale
Time frame: The scale was filled twice, with an average of two hours, in the first 24 hours after delivery, when the mother was free of pain and felt well.
LATCH consists of the combination of the first letters of the English equivalent of the five criteria defined above. Each item is evaluated between 0-2 points. The lowest score that can be obtained from the entire scale is 0 and the highest score is 10. The scale has no breakpoints. The low score on the scale indicates the need for active intervention, support and follow-up after discharge in breastfeeding. The higher the LATCH Breastfeeding Diagnosis and Evaluation Scale score, the higher the success of breastfeeding. Cronbach's alpha value was found to be 0.95 in the study in which the Turkish validity and reliability of the scale was carried out.
2 secondary outcomes
Breastfeeding Attitude and Knowledge Questionnaire
Time frame: It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
Breastfeeding Self-Efficacy Scale-Short Form
Time frame: It was applied both in the antenatal period (at 32-36 weeks of pregnancy) and in the postnatal 24 hours.
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 9 Dec 2024.
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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.
Hamide Arslan Tarus, Res. Asist. principal investigator
Marmara University
Gonul Kurt, Assist. Prof study director
Gulhane Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simulation training group in people with Breastfeeding and Education, run by Marmara 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 1 inclusion and 1 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 9 Dec 2024. 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?
LATCH Breastfeeding Diagnostic and Assessment Scale (time frame: The scale was filled twice, with an average of two hours, in the first 24 hours after delivery, when the mother was free of pain and felt well.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Dec 2024.