NCT05949372

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

June 28, 2023

Last Update Submit

July 9, 2023

Conditions

Keywords

Breastfeeding positionfootball holdbiological breastfeedingbiological nuturing

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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.

    Within postpartum 24th hour

Study Arms (2)

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.

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.

Other: Giving a football ( armpit) position

Interventions

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.

Experimental Group : (Biological Breastfeeding Position)

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.

Experimental ( armpit / football breastfeeding position):

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Having a term and primiparous (singular) baby
  • Breast milk is not contraindicated to the baby
  • Absence of nipple problems that will affect breastfeeding
  • 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"

You may not qualify if:

  • 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
  • Not being able to take the desired position for some reason, having a physical disability
  • Transfer to another centre
  • Developing a complication such as respiratory distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, Turkey (Türkiye)

Location

Related Publications (15)

  • Tiryaki Ö., Pekşen S. (2019). Anne Sütü ve Emzirme; Anneler Sordu Biz Cevapladık. Editör: Çınar N. Ankara:Gece Akademi. s. 26-30

    BACKGROUND
  • 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.

    PMID: 36764312BACKGROUND
  • Christian 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.

    PMID: 33831952BACKGROUND
  • Duan 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.

    PMID: 27577724BACKGROUND
  • WHO. (2020). Newborns: improving survival and well-being. https://www.who.int/news-room/fact-sheets/detail/newborns-reducing-mortality Erişim Tarihi: 05.03.2023

    BACKGROUND
  • 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

    BACKGROUND
  • Çınar N., Şahin S. (2020) Anne ve Çocuk Sağlığı ilk 1000 gün. Akademisyen Kitabevi. Ankara. S:264

    BACKGROUND
  • Colson S. 2018. Biological nurturing; İnstinctual Breastfeeding. Foreword by Kerstin Uvnas Moberg; 2 nd revised and uodated edition, London, Pinter & Martin, 4-148.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 18243594BACKGROUND
  • WHO. (2023). Erişim adresi: https://www.who.int/health-topics/breastfeeding#tab=tab_1 Erişimtarihi: 05.03.2023.

    BACKGROUND
  • 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.

    PMID: 26869575BACKGROUND
  • Ezeukwu 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.

    PMID: 32417825BACKGROUND
  • Reni, 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.

    BACKGROUND
  • 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.

    PMID: 28384091BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Dilek Menekşe, Asist.Prof.

    Sakarya University

    STUDY DIRECTOR
  • Sema Aktaş, Nurse

    Sakarya University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek Menekşe, Asist.Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single-blind (researchers are not blinded) randomization will be provided, as the breastfeeding position will be given to the mother and newborn by the researchers. The statistician was also blinded for the data analysis purpose
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 18, 2023

Study Start

July 15, 2023

Primary Completion

November 15, 2024

Study Completion

November 15, 2024

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations