Clinical trial NCT05949372: The Effect of Breastfeeding Position on Breastfeeding Self-efficacy, Success and Postpartum Comfort
Official title: The Effect of Two Different Breastfeeding Positions on Breastfeeding Self-efficacy, Breastfeeding Success and Postpartum Comfort in Primiparous Mothers.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding position
football hold
biological breastfeeding
biological nuturing
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 68
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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
* 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"

Exclusion Criteria:

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
* 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

Primary outcomes:
measure: The effect of Group 1 (biological breastfeeding position) and Group 2 (armpit / football breastfeeding position) on breastfeeding self-efficacy.
timeFrame: Within postpartum 24th hour
measure: The effect of Group 1 (biological breastfeeding position) and Group 2 (armpit / football breastfeeding position) on breastfeeding success.
timeFrame: Within postpartum 24th hour
Secondary outcomes:
measure: The effect of Group 1 (biological breastfeeding position) and Group 2 (armpit / football breastfeeding position) on postpartum comfort.
timeFrame: Within postpartum 24th hour
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University
Study officials:
affiliation: Sakarya University
name: Dilek Menekşe, Asist.Prof.
role: STUDY_DIRECTOR
affiliation: Sakarya University
name: Sema Aktaş, Nurse
role: PRINCIPAL_INVESTIGATOR
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