Postpartum ComplicationNCT06081374
The Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems
A study testing simulation implication in people with Postpartum Complication and Caesarean Section;Stillbirth, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, there are studies conducted to determine the effect of simulation-based and different training techniques models given in the prenatal period on postpartum breastfeeding self-efficacy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Complication, Caesarean Section;Stillbirth
- What is being tested?
- simulation implication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Nov 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnants between32nd-36th gestational weeks,
- Primigravida,
- Planning to breastfeed,
- Can speak and understand Turkish,
- Pregnant women who agreed to participate in the study were included.
Who cannot join
- Breastfeeding contraindications,
- Having a risky pregnancy, Having received a planned breastfeeding training before,
- Premature birth (before 37th weeks of gestation),
- Having a systemic/chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems: A Randomized Controlled Study
In the literature, there are studies conducted to determine the effect of simulation-based and different training techniques models given in the prenatal period on postpartum breastfeeding self-efficacy. However, no study was found that evaluated the effects of simulation-based and different training techniques given in the prenatal period on breastfeeding self-efficacy and breastfeeding problems. Therefore, this study was planned to determine the effect of simulation-based breastfeeding education on breastfeeding self-efficacy and breastfeeding problems in the prenatal period.
- Being tested
- simulation implication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation implicationDevice
Also called nursing education
Breastfeeding education is planned by dressing pregnant women with simulation models.
| Study group | Role | What they receive |
|---|---|---|
| simulation intervention | Experimental | simulation will be implemented. Receives: Device: simulation implication |
| education implication | Active comparator | education will be implemented. Receives: Device: simulation implication |
| control group | No intervention | no intervention will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
simulation affect on breastfeeding self-efficacy
It is planned to increase women's breastfeeding self-efficacy through training Breastfeeding Self-efficacy scale points are supposed to be between 14-70 points. Getting higher points shows better breastfeeding self-efficacy.
Measured: postpartum 7th week
simulation affect on breastfeeding problems
It is planned to prevent possible breast problems with the training given to women. It is supposed to get points from 18 to 90 related to Breastfeeding Experience Scale.Getting lower points is more preferable than higher points. Getting points near to 90 shows increased problems related to breastfeeding.
Measured: postpartum 7th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum ComplicationStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seda karaçay yıkar, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081374
- Sponsor's protocol ID
- 123
- Status last verified
- Sep 2023
- First submitted
- 10 Jul 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will be kept in confident
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Simulation-based Breastfeeding Education on Breastfeeding Self-efficacy and Breastfeeding Problems: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06081374
- Acronym / sponsor ID
- 123
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 13 Oct 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.
In the literature, there are studies conducted to determine the effect of simulation-based and different training techniques models given in the prenatal period on postpartum breastfeeding self-efficacy. However, no study was found that evaluated the effects of simulation-based and different training techniques given in the prenatal period on breastfeeding self-efficacy and breastfeeding problems. Therefore, this study was planned to determine the effect of simulation-based breastfeeding education on breastfeeding self-efficacy and breastfeeding problems in the prenatal period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| simulation intervention | Experimental | Device: simulation implicationsimulation will be implemented. |
| education implication | Active comparator | Device: simulation implicationeducation will be implemented. |
| control group | No intervention | –no intervention will be made. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnants between32nd-36th gestational weeks,
- Primigravida,
- Planning to breastfeed,
- Can speak and understand Turkish,
- Pregnant women who agreed to participate in the study were included.
Key exclusion criteria (4 listed)
- Breastfeeding contraindications,
- Having a systemic/chronic disease
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 implicationAlso: nursing educationBreastfeeding education is planned by dressing pregnant women with simulation models. | Device | education implication, simulation intervention |
Primary outcome
simulation affect on breastfeeding self-efficacy
Time frame: postpartum 7th week
It is planned to increase women's breastfeeding self-efficacy through training Breastfeeding Self-efficacy scale points are supposed to be between 14-70 points. Getting higher points shows better breastfeeding self-efficacy.
simulation affect on breastfeeding problems
Time frame: postpartum 7th week
It is planned to prevent possible breast problems with the training given to women. It is supposed to get points from 18 to 90 related to Breastfeeding Experience Scale.Getting lower points is more preferable than higher points. Getting points near to 90 shows increased problems related to breastfeeding.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No. data will be kept in confident
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 implication in people with Postpartum Complication and Caesarean Section;Stillbirth, run by Cukurova 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 5 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: status not confirmed, as of the sponsor's last update on 13 Oct 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?
Results are not available in the source record.
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?
simulation affect on breastfeeding self-efficacy (time frame: postpartum 7th week). The study lists 2 primary outcomes in all. 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 13 Oct 2023.