Breast FeedingBNTPBSSNCT05342831
Biological Nutrition Technique Which is Used in Initiation of Breastfeeding
A study testing Biological Nutrition Technique in people with Breast Feeding and Self Efficacy, run by Hatice Gul OZTAS at 1 site in Turkey (Türkiye).
Trial summary
Aim: This research was conducted with the purpose of determining the effect of biological nurturing technique used for starting breastfeeding in primipara on breastfeeding success and self-efficacy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Self Efficacy
- What is being tested?
- Biological Nutrition Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Feb 2020to 5 Jun 2021
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being 18 years and older,
- Having a full-term, single and healthy newborn,
- Having no known health problems
- Having no general anesthesia
- Implementation of planned cesarean delivery,
- Primiparous women who do not have a condition that prevents breastfeeding. Inclusion criteria of the research for infants
Who cannot join
- Women with a risky pregnancy diagnosis (such as preeclampsia, placenta previa, gestational diabetes)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş ISU
Kahramanmaraş, K.Maraş, 46100
About this study
Official title: The Effect of Biological Nutrition Technique Which is Used in Initiation of Breastfeeding in Primiparas on Breastfeeding Success and on Self-Efficacy: A Randomized Controlled Study
Aim: This research was conducted with the purpose of determining the effect of biological nurturing technique used for starting breastfeeding in primipara on breastfeeding success and self-efficacy.
Material and Method: This randomized controlled study was conducted with 130 mothers who had a cesarean section in a public hospital located in Southeast Turkey (65 experimental, 65 control).
Read the detailed description
Aim: This research was conducted with the purpose of determining the effect of biological nurturing technique used for starting breastfeeding in primipara on breastfeeding success and self-efficacy.
Material and Method: This randomized controlled study was conducted with 130 mothers who had a cesarean section in a public hospital located in Southeast Turkey (65 experimental, 65 control). The mothers in the control group received routine hospital care. The mothers in the experimental group were taught the biological nurturing technique after the first breastfeeding and breastfeeding was provided according to the technique during the hospitalization. Pre-test data were obtained by applying LATCH and BSES-SF to the mothers in the experimental and control groups at the 1st hour after the first breastfeeding. LATCH was re-administered at the end of the 8th and 24th hour postpartum. Post-test data were obtained by administering LATCH and BSES at the end of the 48th hour postpartum.In statistical analysis; count, percentage distribution, arithmetic average, chi-square test, standard deviation, t-test in dependent and independent groups and ANOVA analysis in repeated measurements were used.
- Conditions
- Breast Feeding, Self Efficacy
- Being tested
- Biological Nutrition Technique
- Keywords
- Primiparous, Midwifery
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological Nutrition TechniqueOther
Biological nutrition technique woman trying Biological feeding technique was applied after each breastfeeding. Breastfeeding self-efficacy and breastfeeding success were assessed at regular intervals.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: experimental group | Experimental | Biological Nutrition Technique Receives: Other: Biological Nutrition Technique |
| Assigned Interventions | No intervention | standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Measurement:LATCH
Observation and evaluation of mothers' breastfeeding success is measured using the LATCH scale.The LATCH Breastfeeding Diagnostic and Evaluation Scale is a scale filled by the researcher through observation.
L: (Latch on the brest)) A: (Audible Swallowing) T: (Type of Nipple) C: (Comfort of Breast/ Nipple) H: (Hold/ Position)
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.
Measured: Measurement at the second encounter (first 24 hours after birth) for each group.
Second Measurement:Breastfeeding Self-Efficacy Scale Çeviri sonuçları Breastfeeding Self-Efficacy Scale
Breastfeeding self-efficacy levels and breastfeeding self-confidence of mothers are measured with the breastfeeding self-efficacy scale. The Breastfeeding Self-Efficacy Scale (short form) consists of 14 items that measure the mother's breastfeeding self-efficacy. The maximum score that can be obtained from the scale is 70, and the minimum score is 14. High scores from the scale indicate high breastfeeding self-efficacy. The scale is 5-point Likert type; 1 = Not at all sure, 2 = Not so sure, 3 = Sometimes I'm sure, 4 = I'm sure, 5 = I'm very sure.
Measured: Measurement for each group at the third encounter (2th day after birth).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start5 Feb 2020
- Primary completion5 Feb 2021
- Study completion5 Jun 2021
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 Breast FeedingStudies of the same condition, open and under way.
- 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
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatice Gul OZTAS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatice Gul OZTAS, Kahramanmaras Sutcu Imam University
- Investigators
- Hatice Gül Öztaş, Principal investigator, KahramanmaraşISUYeşim Aksoy Derya, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342831
- Sponsor's protocol ID
- KSUHATİCEGULOZTAS001
- Acronym
- BNTPBSS
- Status last verified
- Apr 2022
- First submitted
- 4 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we don't share individual participant data with other researchers
Publications
Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, Cortivo C, Degrassi M, Di Tommaso F, Verardi G, Dipietro L, Piazza M, Scolz S, Rossetto M, Ronfani L; Trieste BN (Biological Nurturing) Investigators. Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.
PubMed 32248838
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Biological Nutrition Technique Which is Used in Initiation of Breastfeeding in Primiparas on Breastfeeding Success and on Self-Efficacy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05342831
- Acronym / sponsor ID
- BNTPBSS / KSUHATİCEGULOZTAS001
- Conditions
- Breast Feeding, Self Efficacy
- Keywords
- Primiparous, Midwifery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hatice Gul OZTASUniversity, hospital or other
- Study start
- 5 Feb 2020 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 25 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.
Aim: This research was conducted with the purpose of determining the effect of biological nurturing technique used for starting breastfeeding in primipara on breastfeeding success and self-efficacy.
Material and Method: This randomized controlled study was conducted with 130 mothers who had a cesarean section in a public hospital located in Southeast Turkey (65 experimental, 65 control).
Detailed description
Aim: This research was conducted with the purpose of determining the effect of biological nurturing technique used for starting breastfeeding in primipara on breastfeeding success and self-efficacy.
Material and Method: This randomized controlled study was conducted with 130 mothers who had a cesarean section in a public hospital located in Southeast Turkey (65 experimental, 65 control). The mothers in the control group received routine hospital care. The mothers in the experimental group were taught the biological nurturing technique after the first breastfeeding and breastfeeding was provided according to the technique during the hospitalization. Pre-test data were obtained by applying LATCH and BSES-SF to the mothers in the experimental and control groups at the 1st hour after the first breastfeeding. LATCH was re-administered at the end of the 8th and 24th hour postpartum. Post-test data were obtained by administering LATCH and BSES at the end of the 48th hour postpartum.In statistical analysis; count, percentage distribution, arithmetic average, chi-square test, standard deviation, t-test in dependent and independent groups and ANOVA analysis in repeated measurements were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental: experimental group | Experimental | Other: Biological Nutrition TechniqueBiological Nutrition Technique |
| Assigned Interventions | No intervention | –standard care group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Being 18 years and older,
- Having a full-term, single and healthy newborn,
- Having no known health problems
- Having no general anesthesia
- Implementation of planned cesarean delivery,
Key exclusion criteria (1 listed)
- Women with a risky pregnancy diagnosis (such as preeclampsia, placenta previa, gestational diabetes)
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 |
|---|---|---|
| Biological Nutrition TechniqueBiological nutrition technique woman trying Biological feeding technique was applied after each breastfeeding. Breastfeeding self-efficacy and breastfeeding success were assessed at regular intervals. | Other | Experimental: experimental group |
Primary outcome
First Measurement:LATCH
Time frame: Measurement at the second encounter (first 24 hours after birth) for each group.
Observation and evaluation of mothers' breastfeeding success is measured using the LATCH scale.The LATCH Breastfeeding Diagnostic and Evaluation Scale is a scale filled by the researcher through observation. L: (Latch on the brest)) A: (Audible Swallowing) T: (Type of Nipple) C: (Comfort of Breast/ Nipple) H: (Hold/ Position) 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.
Second Measurement:Breastfeeding Self-Efficacy Scale Çeviri sonuçları Breastfeeding Self-Efficacy Scale
Time frame: Measurement for each group at the third encounter (2th day after birth).
Breastfeeding self-efficacy levels and breastfeeding self-confidence of mothers are measured with the breastfeeding self-efficacy scale. The Breastfeeding Self-Efficacy Scale (short form) consists of 14 items that measure the mother's breastfeeding self-efficacy. The maximum score that can be obtained from the scale is 70, and the minimum score is 14. High scores from the scale indicate high breastfeeding self-efficacy. The scale is 5-point Likert type; 1 = Not at all sure, 2 = Not so sure, 3 = Sometimes I'm sure, 4 = I'm sure, 5 = I'm very sure.
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 25 Apr 2022.
- Results publication: PubMed 32248838Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, Cortivo C, Degrassi M, Di Tommaso F, Verardi G, Dipietro L, Piazza M, Scolz S, Rossetto M, Ronfani L; Trieste BN (Biological Nurturing) Investigators. Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.
- Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. we don't share individual participant data with 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.
Hatice Gül Öztaş principal investigator
KahramanmaraşISU
Yeşim Aksoy Derya study director
Inonu 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 Biological Nutrition Technique in people with Breast Feeding and Self Efficacy, run by Hatice Gul OZTAS 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 6 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 25 Apr 2022. 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?
First Measurement:LATCH (time frame: Measurement at the second encounter (first 24 hours after birth) for each group.). 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?
On the ClinicalTrials.gov record for NCT05342831, 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 25 Apr 2022.