BreastfeedingNCT05949372
The Effect of Breastfeeding Position on Breastfeeding Self-efficacy, Success and Postpartum Comfort
A study testing Giving a biological breastfeeding position and Giving a football ( armpit) position in people with Breastfeeding, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Breast milk is a natural, unique, ideal food that best meets the nutritional needs of babies for healthy growth and development. Studies clearly demonstrate the short and long-term benefits of breast milk to the baby, mother, family, environment, economy and country with strong evidence. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Giving a biological breastfeeding position and Giving a football ( armpit) position
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2023to 15 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mother's Inclusion Criteria:
- Be over the age of 19
- Able to speak Turkish language
- Without any communication problems and collaborative
- Absence of any complications in pregnancy such as multiple pregnancy, preeclampsia, gestational diabetes, ablation placenta.
- Having a normal vaginal birth
Show all 13Show fewer
- Having a term and primiparous (singular) baby
- Breast milk is not contraindicated to the baby
- Absence of nipple problems that will affect breastfeeding
- No previous breastfeeding experience Newborn's Inclusion Criteria
- Such as craniofacial anomaly such as cleft palate, cleft lip, paralysis of facial muscles, etc. absence of congenital anomalies that would prevent sucking
- APGAR score of 7 or higher in the 5th minute
- Having "sucking, swallowing and breathing coordination"
Who cannot join
- Mother's Exclusion Criteria:
- Refusal to participate in the study
- Not signing the informed consent form
- Having a communication problem
- Desire to leave at any stage of the study or early discharge
- Postpartum bleeding, infection, etc. development in the mother
Show all 10Show fewer
- Not being able to take the desired position for some reason, having a physical disability
- Newborn's Exclusion Criteria:
- Transfer to another centre
- Developing a complication such as respiratory distress
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Two Different Breastfeeding Positions on Breastfeeding Self-efficacy, Breastfeeding Success and Postpartum Comfort in Primiparous Mothers.
Breast milk is a natural, unique, ideal food that best meets the nutritional needs of babies for healthy growth and development. Studies clearly demonstrate the short and long-term benefits of breast milk to the baby, mother, family, environment, economy and country with strong evidence. There are many factors that affect breastfeeding. One of these factors is breastfeeding techniques. Proper breastfeeding technique includes holding the baby well and attaching the baby to the breast correctly, and ineffective breastfeeding techniques, incorrect position and holding style cause poor breastfeeding outcomes in mothers. There are many different breastfeeding positions such as cradle position, cross cradle position, football grip position (armpit position), side-lying breastfeeding, biological breastfeeding. It is of great importance to consider in detail the superiority of these positions over each other. Reveal the advantages of different positions will help increase breastfeeding rates and long-term breastfeeding rates. The aim of this study is to reveal which position is more effective in terms of the effects of biological breastfeeding and armpit (football) breastfeeding positions on breastfeeding self-efficacy, breastfeeding success, breastfeeding duration and postpartum comfort.
The Hypotheses of the Study Hypothesis 0 (H0): There is no difference between biological breastfeeding and armpit (football) breastfeeding position on breastfeeding success, breastfeeding self-efficacy and postpartum comfort in primiparous mothers.
Read more
Hypothesis 1 (H1): Breastfeeding success of primiparous mothers in the biological breastfeeding position is higher than in the armpit (football) breastfeeding position.
Hypothesis 2 (H2): Breastfeeding self-efficacy of primiparous mothers in the biological breastfeeding position is higher than in the armpit (football) breastfeeding position.
Hypothesis 3 (H3): Breastfeeding duration of primiparous mothers in the biological breastfeeding position is higher than in the armpit (Football) breastfeeding position.
Hypothesis 4 (H4): Primiparous mothers have higher comfort in the biological breastfeeding position than in the armpit (Football) breastfeeding position.
Read the detailed description
Breast milk is a natural, unique, ideal food that best meets the nutritional needs of babies for healthy growth and development. Breastfeeding, which has no alternative for the future of societies and the planet, is a fundamental public health priority and goal for all countries. Breast milk is more than just a form of nutrition for the baby. It provides immunity against the vulnerable and immature systems of the newborn and helps protect against many common childhood diseases, both infectious and non-communicable. In addition to protecting children's health, breast milk has the potential to protect women's health and save their lives. Studies clearly demonstrate the short and long-term benefits of breast milk to the baby, mother, family, environment, economy and country with strong evidence .
According to the World Health Organization (WHO), initiating breastfeeding within the first hour is one of the basic neonatal care and should cover every newborn. At the same time, it is recommended to give only breast milk in the first 6 months of life, to continue breastfeeding at 2 years of age and beyond, and to give nutritionally sufficient and safe complementary foods at 6 months. Worldwide, 44% of infants aged 0-6 months were exclusively breastfed in the 2015-2020 period. One of the goals of WHO in its comprehensive implementation plan on maternal, infant and young child nutrition is to increase the rate of exclusive breastfeeding in the first 6 months to at least 50% by 2025. Breastfeeding is not just a physiological event, it is a process that needs to be learned. In this respect, it is of great importance to determine the factors affecting breastfeeding and to deal with successful breastfeeding elements in detail. Successful breastfeeding is a scientifically based art. Proper breastfeeding technique includes holding the baby well and properly attaching the baby to the breast. Ineffective breastfeeding techniques, wrong position and holding style are among the factors that cause poor breastfeeding outcomes in mothers.
There is no standard breastfeeding position, as every mother and baby is special and very different. There are many positions that can be used while breastfeeding. These; cradle, cross cradle, football hold (armpit hold), side-lying breastfeeding, biological breastfeeding positions. There are different studies that compare breastfeeding positions.
It was observed that the mothers in the side lying position were more satisfied with comfort, easy positioning and long-term breastfeeding than the biological nutrition group. In a study comparing reported to pose a low risk three different breastfeeding positions, the football position has been found to be the most biomechanically efficient and has been reported to pose less risk for musculoskeletal disorders in the football position compared to the cradle and cross-cradle positions.In a quasi-experimental study conducted to investigate the effect of biological breastfeeding position on post-cesarean pain, it was observed that moderate post-cesarean pain decreased to mild after biological feeding.
Based on this information, the study was planned to determine the effect of two different breastfeeding positions on breastfeeding success, breastfeeding self-efficacy and postpartum comfort in primiparous mothers.
Method: The population of the study will be composed of primiparous mothers who gave birth in Bursa City Hospital and who were hospitalized in the Gynecology and Obstetrics Clinics between July 2023 and November 2024. The sample will consist of mothers who voluntarily accepted to participate in the study and who met the inclusion criteria of the study between the specified dates. The effect width value was taken as 0.70 as the method used when it was not known how many units difference between the groups was significant. The effect width value gives results of with 0.20 a very high constraint, 0.50 at medium level, and 0.80 under the maximum acceptance constraint. In the case where the 5% tolarance and the 80.15% power level, the effect width value is 0.70, the total number of mothers-infants was determined as 68, including 34 control and 34 experimental groups, which met the inclusion criteria of the research.
Pregnant women will be informed about the purpose of the study, how to collect, store and use data. Verbal and written consents will be obtained from the pregnant women who accept to participate in the study by filling in the "Informed Voluntary Consent Form". Pre-breastfeeding Mother Descriptive Information Form, Newborn Descriptive Information Form, Postpartum Breastfeeding Self-Efficacy Short Form, Postpartum Comfort Scale will be filled face to face with the mother. The first breastfeeding after birth will take place within the first half hour - two hours. The second breastfeeding will be performed 2 hours after the first breastfeeding, and the third breastfeeding will be performed at the 24th hour. Three measurements will be made in total. The breastfeeding duration will be measured with a chronometer in the breastfeedings at these measurement hours. In order to determine the breastfeeding time, after the mother and baby are positioned, the stopwatch will be started when the baby takes the first breast into his mouth. Breastfeeding Scoring System (LATCH) and Postpartum Comfort Scale will be filled in by supporting and observing breastfeeding at each measurement. The LATCH scale will be completed by two observers during breastfeeding. In the last measurement, the Breastfeeding Self-Efficacy Scale will also be filled in. After breastfeeding, the baby's gas will be removed and it will be supported to be in a comfortable and safe position and the mother will be rested.
- Conditions
- Breastfeeding
- Being tested
- Giving a biological breastfeeding position, Giving a football ( armpit) position
- Keywords
- Breastfeeding position, football hold, biological breastfeeding, biological nuturing
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giving a biological breastfeeding positionOther
The mother is half-sitting, in the most comfortable position where she can make eye contact with her baby. The baby's head is placed on the mother's chest with her legs on the mother's stomach. With this position, gravity fixes the baby's whole body to that of its mother.
Giving a football ( armpit) positionOther
The mother sits upright, leaning back, and the baby's bottom and the right or left side of the mother is supported by pillows from whichever side she will breastfeed. The baby's head is placed on the breast that is breastfed and the feet are laid flat so that they pass under the armpit of the breastfed side. While the mother's hand on the breastfeeding side holds the baby's head, the other hand directs the breast towards the baby and breastfeeding is initiated.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group : (Biological Breastfeeding Position) | Experimental | The first breastfeeding after birth will take place within the first half hour - two hours. The second breastfeeding will be performed 2 hours after the first breastfeeding, and the third breastfeeding will be performed at the 24th hour. Three measurements will be made in total.The mother is half-sitting, in the most comfortable position where she can make eye contact with her baby. The baby's head is placed on the mother's chest with her legs on the mother's stomach. With this position, gravity fixes the baby's whole body to that of its mother. The breastfeeding duration will be measured with a chronometer in the breastfeedings at these measurement hours. In order to determine the breastfeeding time, after the mother and baby are positioned, the stopwatch will be started when the baby takes the first breast into his mouth. Data collection forms will be filled. Receives: Other: Giving a biological breastfeeding position |
| Experimental ( armpit / football breastfeeding position): | Experimental | The first breastfeeding after birth will take place within the first half hour - two hours.The second breastfeeding will be performed 2 hours after the first breastfeeding, and the third breastfeeding will be performed at the 24th hour.Three measurements will be made in total.The baby's head is placed on the breast that is breastfed and the feet are laid flat so that they pass under the armpit of the breastfed side.While the mother's hand on the breastfeeding side holds the baby's head, the other hand directs the breast towards the baby and breastfeeding is initiated.The breastfeeding duration will be measured with a chronometer in the breastfeedings at these measurement hours.In order to determine the breastfeeding time, after the mother and baby are positioned, the stopwatch will be started when the baby takes the first breast into his mouth. Data collection forms will be filled. Receives: Other: Giving a football ( armpit) position |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of Group 1 (biological breastfeeding position) and Group 2 (armpit / football breastfeeding position) on breastfeeding self-efficacy.
(Breast-Feeding Self-Efficacy Scale- Short Form/BSES-SF): (Breast-Feeding Self-Efficacy Scale- Short Form/BSES-SF): Breastfeeding Self-Efficacy Scale is a 33-item scale developed by Dennis and Faux in 1999. The Breastfeeding Self-Efficacy Scale Short Form was developed by Dennis (2003) by reducing it to a 14-item scale. The validity and reliability of the scale in our country was done by Tokat Aluş, Okumus, and Dennis (2010). The scale is a 5-point Likert-type scale and is evaluated as I am never sure (1 point) and I am always sure (5 points). The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The scale has no breakpoints. An increase in the scale score means higher breastfeeding self-efficacy. The cronbach alpha value of the scale was found to be 0.87.
Measured: Within postpartum 24th hour
The effect of Group 1 (biological breastfeeding position) and Group 2 (armpit / football breastfeeding position) on breastfeeding success.
LATCH : Jensen et al. (1994) provides a systematic evaluation of breastfeeding and the identification of areas that require intervention in breastfeeding. Each letter of the abbreviation LATCH indicates a breastfeeding assessment area.
- "L" baby's ability to grasp the breast,
- "A" The presence of baby audible swallowing at the breast,
- "T" mother's nipple type,
- "C" is the mother's sense of comfort,
- "H" refers to the position the mother uses to hold or breastfeed, and the amount of help the mother needs to hold the baby.
Scale evaluation is done by giving 0, 1 and 2 points to each item. Breastfeeding success is evaluated by summing the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0. An increase in the scores obtained from the scale indicates the success of breastfeeding.
Measured: Within postpartum 24th hour
Secondary outcomes (1)
The effect of Group 1 (biological breastfeeding position) and Group 2 (armpit / football breastfeeding position) on postpartum comfort.
Postpartum Comfort Scale: The postpartum comfort scale was developed by Karakaplan and Yıldız in 2010. It was developed to evaluate the postpartum comfort of mothers who had cesarean section or normal vaginal delivery in a holistic approach based on the comfort theory and is used to evaluate the physical, psychospiritual, sociocultural and environmental comforts of mothers as a whole.The scale consists of 34 items.. The average value is determined by dividing the total score obtained from the scale by the number of items, and the result is shown in the 1-5 distribution. Basically, low comfort is expressed with 1 and high comfort with 5. The lowest score to be taken from the scale is 34 and the highest score is 170. An increase in the total score obtained from the scale indicates that the comfort level is high.
Measured: Within postpartum 24th hour
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 start15 Jul 2023 (estimated)
- Primary completion15 Nov 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dilek menekşe, Sakarya University
- Investigators
- Dilek Menekşe, Asist.Prof., Study director, Sakarya UniversitySema Aktaş, Nurse, Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949372
- Sponsor's protocol ID
- Sema Aktaş
- Status last verified
- Jul 2023
- First submitted
- 28 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tiryaki Ö., Pekşen S. (2019). Anne Sütü ve Emzirme; Anneler Sordu Biz Cevapladık. Editör: Çınar N. Ankara:Gece Akademi. s. 26-30
Doherty T, Horwood C, Pereira-Kotze C, du Plessis L, Witten C. Stemming commercial milk formula marketing: now is the time for radical transformation to build resilience for breastfeeding. Lancet. 2023 Feb 11;401(10375):415-418. doi: 10.1016/S0140-6736(23)00095-8. Epub 2023 Feb 7. No abstract available.
PubMed 36764312Christian P, Smith ER, Lee SE, Vargas AJ, Bremer AA, Raiten DJ. The need to study human milk as a biological system. Am J Clin Nutr. 2021 May 8;113(5):1063-1072. doi: 10.1093/ajcn/nqab075.
PubMed 33831952Duan X, Wang J, Jiang X. A meta-analysis of breastfeeding and osteoporotic fracture risk in the females. Osteoporos Int. 2017 Feb;28(2):495-503. doi: 10.1007/s00198-016-3753-x. Epub 2016 Aug 30.
PubMed 27577724WHO. (2020). Newborns: improving survival and well-being. https://www.who.int/news-room/fact-sheets/detail/newborns-reducing-mortality Erişim Tarihi: 05.03.2023
WHO, (2021). Infant and young child feding. https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding Erişim Tarihi: 05.03.2023
Çınar N., Şahin S. (2020) Anne ve Çocuk Sağlığı ilk 1000 gün. Akademisyen Kitabevi. Ankara. S:264
Colson S. 2018. Biological nurturing; İnstinctual Breastfeeding. Foreword by Kerstin Uvnas Moberg; 2 nd revised and uodated edition, London, Pinter & Martin, 4-148.
Davra, K., Chavda, P., Pandya, C., Dave, D., & Mehta, K. (2022). Breastfeeding position and attachment practices among lactating mothers: An urban community-based cross-sectional study from Vadodara city in western India. Clinical Epidemiology and Global Health, 15, 101009.
Colson SD, Meek JH, Hawdon JM. Optimal positions for the release of primitive neonatal reflexes stimulating breastfeeding. Early Hum Dev. 2008 Jul;84(7):441-9. doi: 10.1016/j.earlhumdev.2007.12.003. Epub 2008 Feb 19.
PubMed 18243594WHO. (2023). Erişim adresi: https://www.who.int/health-topics/breastfeeding#tab=tab_1 Erişimtarihi: 05.03.2023.
Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
PubMed 26869575Ezeukwu OA, Ojukwu CP, Okemuo AJ, Anih CF, Ikele IT, Chukwu SC. Biomechanical analysis of the three recommended breastfeeding positions. Work. 2020;66(1):183-191. doi: 10.3233/WOR-203162.
PubMed 32417825Reni, C., Sinar, P., & Etin, R. (2020). Effect of Biologic Nurturing Baby Led Feeding on Post Sectio Caesarea Pain Scale In Majenang Hospital 2018. Midwifery And Nursing Research (MANR) Journal, 2(1), 22-27.
Puapornpong P, Raungrongmorakot K, Laosooksathit W, Hanprasertpong T, Ketsuwan S. Comparison of Breastfeeding Outcomes Between Using the Laid-Back and Side-Lying Breastfeeding Positions in Mothers Delivering by Cesarean Section: A Randomized Controlled Trial. Breastfeed Med. 2017 May;12:233-237. doi: 10.1089/bfm.2016.0193. Epub 2017 Apr 6.
PubMed 28384091
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Breastfeeding Positions on Breastfeeding Self-efficacy, Breastfeeding Success and Postpartum Comfort in Primiparous Mothers.
- ClinicalTrials.gov ID
- NCT05949372
- Acronym / sponsor ID
- Sema Aktaş
- Conditions
- Breastfeeding
- Keywords
- Breastfeeding position, football hold, biological breastfeeding, biological nuturing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- 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.
Breast milk is a natural, unique, ideal food that best meets the nutritional needs of babies for healthy growth and development. Studies clearly demonstrate the short and long-term benefits of breast milk to the baby, mother, family, environment, economy and country with strong evidence. There are many factors that affect breastfeeding. One of these factors is breastfeeding techniques. Proper breastfeeding technique includes holding the baby well and attaching the baby to the breast correctly, and ineffective breastfeeding techniques, incorrect position and holding style cause poor breastfeeding outcomes in mothers. There are many different breastfeeding positions such as cradle position, cross cradle position, football grip position (armpit position), side-lying breastfeeding, biological breastfeeding. It is of great importance to consider in detail the superiority of these positions over each other. Reveal the advantages of different positions will help increase breastfeeding rates and long-term breastfeeding rates. The aim of this study is to reveal which position is more effective in terms of the effects of biological breastfeeding and armpit (football) breastfeeding positions on breastfeeding self-efficacy, breastfeeding success, breastfeeding duration and postpartum comfort.
The Hypotheses of the Study Hypothesis 0 (H0): There is no difference between biological breastfeeding and armpit (football) breastfeeding position on breastfeeding success, breastfeeding self-efficacy and postpartum comfort in primiparous mothers.
Hypothesis 1 (H1): Breastfeeding success of primiparous mothers in the biological breastfeeding position is higher than in the armpit (football) breastfeeding position.
Hypothesis 2 (H2): Breastfeeding self-efficacy of primiparous mothers in the biological breastfeeding position is higher than in the armpit (football) breastfeeding position.
Hypothesis 3 (H3): Breastfeeding duration of primiparous mothers in the biological breastfeeding position is higher than in the armpit (Football) breastfeeding position.
Hypothesis 4 (H4): Primiparous mothers have higher comfort in the biological breastfeeding position than in the armpit (Football) breastfeeding position.
Detailed description
Breast milk is a natural, unique, ideal food that best meets the nutritional needs of babies for healthy growth and development. Breastfeeding, which has no alternative for the future of societies and the planet, is a fundamental public health priority and goal for all countries. Breast milk is more than just a form of nutrition for the baby. It provides immunity against the vulnerable and immature systems of the newborn and helps protect against many common childhood diseases, both infectious and non-communicable. In addition to protecting children's health, breast milk has the potential to protect women's health and save their lives. Studies clearly demonstrate the short and long-term benefits of breast milk to the baby, mother, family, environment, economy and country with strong evidence .
According to the World Health Organization (WHO), initiating breastfeeding within the first hour is one of the basic neonatal care and should cover every newborn. At the same time, it is recommended to give only breast milk in the first 6 months of life, to continue breastfeeding at 2 years of age and beyond, and to give nutritionally sufficient and safe complementary foods at 6 months. Worldwide, 44% of infants aged 0-6 months were exclusively breastfed in the 2015-2020 period. One of the goals of WHO in its comprehensive implementation plan on maternal, infant and young child nutrition is to increase the rate of exclusive breastfeeding in the first 6 months to at least 50% by 2025. Breastfeeding is not just a physiological event, it is a process that needs to be learned. In this respect, it is of great importance to determine the factors affecting breastfeeding and to deal with successful breastfeeding elements in detail. Successful breastfeeding is a scientifically based art. Proper breastfeeding technique includes holding the baby well and properly attaching the baby to the breast. Ineffective breastfeeding techniques, wrong position and holding style are among the factors that cause poor breastfeeding outcomes in mothers.
There is no standard breastfeeding position, as every mother and baby is special and very different. There are many positions that can be used while breastfeeding. These; cradle, cross cradle, football hold (armpit hold), side-lying breastfeeding, biological breastfeeding positions. There are different studies that compare breastfeeding positions.
It was observed that the mothers in the side lying position were more satisfied with comfort, easy positioning and long-term breastfeeding than the biological nutrition group. In a study comparing reported to pose a low risk three different breastfeeding positions, the football position has been found to be the most biomechanically efficient and has been reported to pose less risk for musculoskeletal disorders in the football position compared to the cradle and cross-cradle positions.In a quasi-experimental study conducted to investigate the effect of biological breastfeeding position on post-cesarean pain, it was observed that moderate post-cesarean pain decreased to mild after biological feeding.
Based on this information, the study was planned to determine the effect of two different breastfeeding positions on breastfeeding success, breastfeeding self-efficacy and postpartum comfort in primiparous mothers.
Method: The population of the study will be composed of primiparous mothers who gave birth in Bursa City Hospital and who were hospitalized in the Gynecology and Obstetrics Clinics between July 2023 and November 2024. The sample will consist of mothers who voluntarily accepted to participate in the study and who met the inclusion criteria of the study between the specified dates. The effect width value was taken as 0.70 as the method used when it was not known how many units difference between the groups was significant. The effect width value gives results of with 0.20 a very high constraint, 0.50 at medium level, and 0.80 under the maximum acceptance constraint. In the case where the 5% tolarance and the 80.15% power level, the effect width value is 0.70, the total number of mothers-infants was determined as 68, including 34 control and 34 experimental groups, which met the inclusion criteria of the research.
Pregnant women will be informed about the purpose of the study, how to collect, store and use data. Verbal and written consents will be obtained from the pregnant women who accept to participate in the study by filling in the "Informed Voluntary Consent Form". Pre-breastfeeding Mother Descriptive Information Form, Newborn Descriptive Information Form, Postpartum Breastfeeding Self-Efficacy Short Form, Postpartum Comfort Scale will be filled face to face with the mother. The first breastfeeding after birth will take place within the first half hour - two hours. The second breastfeeding will be performed 2 hours after the first breastfeeding, and the third breastfeeding will be performed at the 24th hour. Three measurements will be made in total. The breastfeeding duration will be measured with a chronometer in the breastfeedings at these measurement hours. In order to determine the breastfeeding time, after the mother and baby are positioned, the stopwatch will be started when the baby takes the first breast into his mouth. Breastfeeding Scoring System (LATCH) and Postpartum Comfort Scale will be filled in by supporting and observing breastfeeding at each measurement. The LATCH scale will be completed by two observers during breastfeeding. In the last measurement, the Breastfeeding Self-Efficacy Scale will also be filled in. After breastfeeding, the baby's gas will be removed and it will be supported to be in a comfortable and safe position and the mother will be rested.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental Group : (Biological Breastfeeding Position) | Experimental | Other: Giving a biological breastfeeding positionThe first breastfeeding after birth will take place within the first half hour - two hours. The second breastfeeding will be performed 2 hours after the first breastfeeding, and the third breastfeeding will be performed at the 24th hour. Three measurements will be made in total.The mother is half-sitting, in the most comfortable position where she can make eye contact with her baby. The baby's head is placed on the mother's chest with her legs on the mother's stomach. With this position, gravity fixes the baby's whole body to that of its mother. The breastfeeding duration will be measured with a chronometer in the breastfeedings at these measurement hours. In order to determine the breastfeeding time, after the mother and baby are positioned, the stopwatch will be started when the baby takes the first breast into his mouth. Data collection forms will be filled. |
| Experimental ( armpit / football breastfeeding position): | Experimental | Other: Giving a football ( armpit) positionThe first breastfeeding after birth will take place within the first half hour - two hours.The second breastfeeding will be performed 2 hours after the first breastfeeding, and the third breastfeeding will be performed at the 24th hour.Three measurements will be made in total.The baby's head is placed on the breast that is breastfed and the feet are laid flat so that they pass under the armpit of the breastfed side.While the mother's hand on the breastfeeding side holds the baby's head, the other hand directs the breast towards the baby and breastfeeding is initiated.The breastfeeding duration will be measured with a chronometer in the breastfeedings at these measurement hours.In order to determine the breastfeeding time, after the mother and baby are positioned, the stopwatch will be started when the baby takes the first breast into his mouth. Data collection forms will be filled. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be over the age of 19
- Able to speak Turkish language
- Without any communication problems and collaborative
- Absence of any complications in pregnancy such as multiple pregnancy, preeclampsia, gestational diabetes, ablation placenta.
- Having a normal vaginal birth
Key exclusion criteria (10 listed)
- Refusal to participate in the study
- Not signing the informed consent form
- Having a communication problem
- Desire to leave at any stage of the study or early discharge
- Postpartum bleeding, infection, etc. development in the mother
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 |
|---|---|---|
| Giving a biological breastfeeding positionThe mother is half-sitting, in the most comfortable position where she can make eye contact with her baby. The baby's head is placed on the mother's chest with her legs on the mother's stomach. With this position, gravity fixes the baby's whole body to that of its mother. | Other | Experimental Group : (Biological Breastfeeding Position) |
| Giving a football ( armpit) positionThe mother sits upright, leaning back, and the baby's bottom and the right or left side of the mother is supported by pillows from whichever side she will breastfeed. The baby's head is placed on the breast that is breastfed and the feet are laid flat so that they pass under the armpit of the breastfed side. While the mother's hand on the breastfeeding side holds the baby's head, the other hand directs the breast towards the baby and breastfeeding is initiated. | Other | Experimental ( armpit / football breastfeeding position): |
Primary outcome
The effect of Group 1 (biological breastfeeding position) and Group 2 (armpit / football breastfeeding position) on breastfeeding self-efficacy.
Time frame: Within postpartum 24th hour
(Breast-Feeding Self-Efficacy Scale- Short Form/BSES-SF): (Breast-Feeding Self-Efficacy Scale- Short Form/BSES-SF): Breastfeeding Self-Efficacy Scale is a 33-item scale developed by Dennis and Faux in 1999. The Breastfeeding Self-Efficacy Scale Short Form was developed by Dennis (2003) by reducing it to a 14-item scale. The validity and reliability of the scale in our country was done by Tokat Aluş, Okumus, and Dennis (2010). The scale is a 5-point Likert-type scale and is evaluated as I am never sure (1 point) and I am always sure (5 points). The minimum score that can be obtained from the scale is 14, and the maximum score is 70. The scale has no breakpoints. An increase in the scale score means higher breastfeeding self-efficacy. The cronbach alpha value of the scale was found to be 0.87.
The effect of Group 1 (biological breastfeeding position) and Group 2 (armpit / football breastfeeding position) on breastfeeding success.
Time frame: Within postpartum 24th hour
LATCH : Jensen et al. (1994) provides a systematic evaluation of breastfeeding and the identification of areas that require intervention in breastfeeding. Each letter of the abbreviation LATCH indicates a breastfeeding assessment area. * "L" baby's ability to grasp the breast, * "A" The presence of baby audible swallowing at the breast, * "T" mother's nipple type, * "C" is the mother's sense of comfort, * "H" refers to the position the mother uses to hold or breastfeed, and the amount of help the mother needs to hold the baby. Scale evaluation is done by giving 0, 1 and 2 points to each item. Breastfeeding success is evaluated by summing the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0. An increase in the scores obtained from the scale indicates the success of breastfeeding.
1 secondary outcome
The effect of Group 1 (biological breastfeeding position) and Group 2 (armpit / football breastfeeding position) on postpartum comfort.
Time frame: Within postpartum 24th hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- BackgroundTiryaki Ö., Pekşen S. (2019). Anne Sütü ve Emzirme; Anneler Sordu Biz Cevapladık. Editör: Çınar N. Ankara:Gece Akademi. s. 26-30
- Background: PubMed 36764312Doherty T, Horwood C, Pereira-Kotze C, du Plessis L, Witten C. Stemming commercial milk formula marketing: now is the time for radical transformation to build resilience for breastfeeding. Lancet. 2023 Feb 11;401(10375):415-418. doi: 10.1016/S0140-6736(23)00095-8. Epub 2023 Feb 7. No abstract available.
- Background: PubMed 33831952Christian P, Smith ER, Lee SE, Vargas AJ, Bremer AA, Raiten DJ. The need to study human milk as a biological system. Am J Clin Nutr. 2021 May 8;113(5):1063-1072. doi: 10.1093/ajcn/nqab075.
- Background: PubMed 27577724Duan X, Wang J, Jiang X. A meta-analysis of breastfeeding and osteoporotic fracture risk in the females. Osteoporos Int. 2017 Feb;28(2):495-503. doi: 10.1007/s00198-016-3753-x. Epub 2016 Aug 30.
- BackgroundWHO. (2020). Newborns: improving survival and well-being. https://www.who.int/news-room/fact-sheets/detail/newborns-reducing-mortality Erişim Tarihi: 05.03.2023
- BackgroundWHO, (2021). Infant and young child feding. https://www.who.int/news-room/fact-sheets/detail/infant-and-young-child-feeding Erişim Tarihi: 05.03.2023
- BackgroundÇınar N., Şahin S. (2020) Anne ve Çocuk Sağlığı ilk 1000 gün. Akademisyen Kitabevi. Ankara. S:264
- BackgroundColson S. 2018. Biological nurturing; İnstinctual Breastfeeding. Foreword by Kerstin Uvnas Moberg; 2 nd revised and uodated edition, London, Pinter & Martin, 4-148.
- BackgroundDavra, K., Chavda, P., Pandya, C., Dave, D., & Mehta, K. (2022). Breastfeeding position and attachment practices among lactating mothers: An urban community-based cross-sectional study from Vadodara city in western India. Clinical Epidemiology and Global Health, 15, 101009.
- Background: PubMed 18243594Colson SD, Meek JH, Hawdon JM. Optimal positions for the release of primitive neonatal reflexes stimulating breastfeeding. Early Hum Dev. 2008 Jul;84(7):441-9. doi: 10.1016/j.earlhumdev.2007.12.003. Epub 2008 Feb 19.
- BackgroundWHO. (2023). Erişim adresi: https://www.who.int/health-topics/breastfeeding#tab=tab_1 Erişimtarihi: 05.03.2023.
- Background: PubMed 26869575Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
- Individual participant dataSharing planned: No
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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.
Dilek Menekşe, Asist.Prof. study director
Sakarya University
Sema Aktaş, Nurse principal investigator
Sakarya 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 Giving a biological breastfeeding position and Giving a football ( armpit) position in people with Breastfeeding, run by Sakarya 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 13 inclusion and 10 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 18 Jul 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?
Contact Dilek Menekşe, Asist.Prof. (0264 295 6613, dkose@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of Group 1 (biological breastfeeding position) and Group 2 (armpit / football breastfeeding position) on breastfeeding self-efficacy. (time frame: Within postpartum 24th hour). 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 NCT05949372, which also lists 15 linked publications.
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 Jul 2023.