WomenNCT05817773
The Design, Development and Effect of Breastfeeding Cradle on Breastfeeding Self-efficacy
A study testing breastfeeding cradle in people with Women, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
After cesarean section, mothers who are not mobile and cannot take a suitable position to breastfeed their baby, with the designed breastfeeding cradle, the baby approaches the mother's breast and by taking the appropriate position, effective and easy breastfeeding is ensured. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women
- What is being tested?
- breastfeeding cradle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2021to 15 Sep 2022
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18- 35 years old, Primipar, At least primary school graduate, No high-risk pregnancy Absence of any complications in the birth and postpartum period in the newborn and himself.
Who cannot join
- Those who have any contraindication for breastfeeding Having a baby under 3000 g, Mothers whose baby was not with them due to any health reasons were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk Unıversıty
Erzurum, Erzurum/Yakutiye, 25000
About this study
After cesarean section, mothers who are not mobile and cannot take a suitable position to breastfeed their baby, with the designed breastfeeding cradle, the baby approaches the mother's breast and by taking the appropriate position, effective and easy breastfeeding is ensured.
Read the detailed description
Breastfeeding is considered the most appropriate feeding method because it has many benefits for mother and baby. The benefit of breast milk, which is the most beneficial and unique feeding method for the healthy growth and development of babies biologically, psychologically and emotionally, is indisputable. There is no doubt that breast milk is one of the greatest life savers and that breast milk is a miracle.
Breastfeeding within the first half hour after birth is one of the Baby-Friendly Hospital criteria, a program of the World Health Organization (WHO) and the United Nations International Children's Emergency Fund (UNICEF). The baby's active period after birth is the first half hour. In this process, breastfeeding affects the success of breastfeeding and the duration of breastfeeding positively. Failure to start breastfeeding in the early postpartum period and the lack of a successful breastfeeding process can have important consequences for the health of the mother and baby in the short and long term. WHO states that breastfeeding in the first half-hour period after birth reduces the risk of death and disease in infants, and then increases breastfeeding rates. International and national organizations have stated that breastfeeding of mothers in the first half-hour period after birth increases the probability of survival of babies, skin-to-skin contact is achieved earlier, increases milk production, including colostrum, and increases uterine involution.
There has been a significant increase in cesarean section rates in our country as well as in the world in recent years. According to Turkey Demographic Health Survey (TNSA) 2018 data, cesarean deliveries account for 52% of all deliveries in Turkey. Mothers with cesarean section experience more problems with breastfeeding compared to mothers who gave birth normally. Some of the most important problems with breastfeeding after cesarean section are that mothers have difficulty breastfeeding without the help of someone due to the limitation of movement after cesarean section. Another problem experienced in the early postpartum period after cesarean section is that mothers may not want to breastfeed their babies because of the concern that the baby will experience pain after the baby's contact instead of the cesarean section incision while breastfeeding. Expecting the mother to be mobile for the first breastfeeding negatively affects breastfeeding self-efficacy. The need for support is higher in cesarean deliveries than in normal births. For this, there must be sufficient midwives who can be sufficient here. It is thought that the most important factor in the failure of breastfeeding after cesarean section is the wrong breastfeeding position. In order for breastfeeding to be easier and more comfortable, the tools produced to support breastfeeding should be useful, easy and effective in breastfeeding. Tools used in breastfeeding self-efficacy; breastfeeding support system, breastfeeding pillow, breastfeeding apron and breastfeeding chair.
- Conditions
- Women
- Being tested
- breastfeeding cradle
- Keywords
- breastfeeding cradle, breastfeeding self-efficacy, postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeeding cradleDevice
Mothers with postop mobile cesarean section should be breastfed with a nursing cradle for 30 minutes every 2-3 hours, even if the baby does not cry, until after mobilization (for 6 hours after coming to the service) every time the baby cries.
| Study group | Role | What they receive |
|---|---|---|
| breastfeeding cradle | Experimental | After the control group was given breastfeeding education and the baby was breastfed, the questionnaire and breastfeeding self-efficacy scale were applied at the 6th hour postoperatively. The experimental group was given breastfeeding education and the baby was placed in a nursing cradle and the baby was breastfed. Then, the questionnaire and breastfeeding self-efficacy scale were applied at the 6th hour postoperatively. Receives: Device: breastfeeding cradle |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of breastfeeding cradle on breastfeeding self-efficacy
breastfeeding cradle is effective on breastfeeding self-efficacy
Measured: seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 May 2021
- Primary completion15 Jul 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomenStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Breastfeeding cradle with remote control system is designed for the mother to breastfeed her baby comfortably. The mother can breastfeed her baby in any position without getting out of bed. Thanks to the remote control, it can give the cradle the desired position. She can safely breastfeed her baby in the cradle with seat belt and safety lock. Breastfeeding cradle with massage, music and light system will provide high comfort for mother and baby.
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap Nailoglu, Ataturk University
- Investigators
- Serap EJDER APAY, prof, Principal investigator, ataturk university midwifery department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817773
- Sponsor's protocol ID
- AtaturkU MNailoglu0001
- Status last verified
- Jun 2023
- First submitted
- 23 Feb 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not a plan for use of individual participant data (IPD) by other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Design, Development and Effect of Breastfeeding Cradle on Breastfeeding Self-efficacy
- ClinicalTrials.gov ID
- NCT05817773
- Acronym / sponsor ID
- AtaturkU MNailoglu0001
- Conditions
- Women
- Keywords
- breastfeeding cradle, breastfeeding self-efficacy, postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 18 Apr 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.
After cesarean section, mothers who are not mobile and cannot take a suitable position to breastfeed their baby, with the designed breastfeeding cradle, the baby approaches the mother's breast and by taking the appropriate position, effective and easy breastfeeding is ensured.
Detailed description
Breastfeeding is considered the most appropriate feeding method because it has many benefits for mother and baby. The benefit of breast milk, which is the most beneficial and unique feeding method for the healthy growth and development of babies biologically, psychologically and emotionally, is indisputable. There is no doubt that breast milk is one of the greatest life savers and that breast milk is a miracle.
Breastfeeding within the first half hour after birth is one of the Baby-Friendly Hospital criteria, a program of the World Health Organization (WHO) and the United Nations International Children's Emergency Fund (UNICEF). The baby's active period after birth is the first half hour. In this process, breastfeeding affects the success of breastfeeding and the duration of breastfeeding positively. Failure to start breastfeeding in the early postpartum period and the lack of a successful breastfeeding process can have important consequences for the health of the mother and baby in the short and long term. WHO states that breastfeeding in the first half-hour period after birth reduces the risk of death and disease in infants, and then increases breastfeeding rates. International and national organizations have stated that breastfeeding of mothers in the first half-hour period after birth increases the probability of survival of babies, skin-to-skin contact is achieved earlier, increases milk production, including colostrum, and increases uterine involution.
There has been a significant increase in cesarean section rates in our country as well as in the world in recent years. According to Turkey Demographic Health Survey (TNSA) 2018 data, cesarean deliveries account for 52% of all deliveries in Turkey. Mothers with cesarean section experience more problems with breastfeeding compared to mothers who gave birth normally. Some of the most important problems with breastfeeding after cesarean section are that mothers have difficulty breastfeeding without the help of someone due to the limitation of movement after cesarean section. Another problem experienced in the early postpartum period after cesarean section is that mothers may not want to breastfeed their babies because of the concern that the baby will experience pain after the baby's contact instead of the cesarean section incision while breastfeeding. Expecting the mother to be mobile for the first breastfeeding negatively affects breastfeeding self-efficacy. The need for support is higher in cesarean deliveries than in normal births. For this, there must be sufficient midwives who can be sufficient here. It is thought that the most important factor in the failure of breastfeeding after cesarean section is the wrong breastfeeding position. In order for breastfeeding to be easier and more comfortable, the tools produced to support breastfeeding should be useful, easy and effective in breastfeeding. Tools used in breastfeeding self-efficacy; breastfeeding support system, breastfeeding pillow, breastfeeding apron and breastfeeding chair.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Breastfeeding cradle with remote control system is designed for the mother to breastfeed her baby comfortably. The mother can breastfeed her baby in any position without getting out of bed. Thanks to the remote control, it can give the cradle the desired position. She can safely breastfeed her baby in the cradle with seat belt and safety lock. Breastfeeding cradle with massage, music and light system will provide high comfort for mother and baby.
| Arm | Type | Receives |
|---|---|---|
| breastfeeding cradle | Experimental | Device: breastfeeding cradleAfter the control group was given breastfeeding education and the baby was breastfed, the questionnaire and breastfeeding self-efficacy scale were applied at the 6th hour postoperatively. The experimental group was given breastfeeding education and the baby was placed in a nursing cradle and the baby was breastfed. Then, the questionnaire and breastfeeding self-efficacy scale were applied at the 6th hour postoperatively. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18- 35 years old, Primipar, At least primary school graduate, No high-risk pregnancy Absence of any complications in the birth and postpartum period in the newborn and himself.
Key exclusion criteria (1 listed)
- Those who have any contraindication for breastfeeding Having a baby under 3000 g, Mothers whose baby was not with them due to any health reasons were not included in 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 |
|---|---|---|
| breastfeeding cradleMothers with postop mobile cesarean section should be breastfed with a nursing cradle for 30 minutes every 2-3 hours, even if the baby does not cry, until after mobilization (for 6 hours after coming to the service) every time the baby cries. | Device | breastfeeding cradle |
Primary outcome
The effect of breastfeeding cradle on breastfeeding self-efficacy
Time frame: seven months
breastfeeding cradle is effective on breastfeeding self-efficacy
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 18 Jun 2023.
- Individual participant dataSharing planned: No. It is not a plan for use of individual participant data (IPD) by other researchers.
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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.
Serap EJDER APAY, prof principal investigator
ataturk university midwifery department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breastfeeding cradle in people with Women, run by Ataturk 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 18 Jun 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?
The effect of breastfeeding cradle on breastfeeding self-efficacy (time frame: seven months). 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 18 Jun 2023.