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Not yet recruiting NCT07144358

Effectiveness of Breastfeeding Arm Sling and Biological Feeding Position in Primiparous Womenl

No phase Interventional Primiparous Women

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biological Feeding Position.
Who it may be relevant to
Registry conditions: Primiparous Women. Basic parameters: 18 years — 49 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effectiveness of Breastfeeding Arm Sling and Biological Feeding Position in Primiparous Women: A Randomized Controlled Trial

Overview

Abstract The World Health Organization (WHO) recommends that babies be fed exclusively with breast milk for the first six months after birth (World Health Organization, 2020). However, for women who are breastfeeding for the first time (primiparas), the breastfeeding process often presents both physical and psychological challenges. In recent years, technological and ergonomic solutions have been developed to support the breastfeeding process, and a new tool called a 'breastfeeding arm sling' is planned to be developed. This arm sling aims to support the mother's arm, allowing the baby to be positioned more stably and thus making the breastfeeding process more comfortable . On the other hand, the biological feeding position (laid-back breastfeeding) is an effective method that uses the effects of gravity to activate the baby's natural reflexes and allows the mother to breastfeed in a comfortable position . This study is a randomised controlled experimental study aimed at comparing the effects of the newly developed Breastfeeding Arm Support and the biological feeding position on breastfeeding in primiparous women. The research will be conducted with primiparous women who gave birth between September and December 2025 at the Women's Delivery Services 1 and 2 of Gaziantep Abdulkadir Yüksel State Hospital. Data will be collected through face-to-face interviews and questionnaire forms in the form of pre-tests and post-tests. The study includes two groups: 1. Group receiving the Breastfeeding Arm Support group (n = 44) 2. Group receiving the Biological Feeding Position (n = 44) Post-intervention post-tests will be administered to both groups, and the results will be compared.

Detailed description

Breastfeeding is a fundamental life process for newborns in terms of nutrition, immunity and emotional bonding. The World Health Organization (WHO) recommends that babies be fed exclusively with breast milk for the first six months after birth . However, the breastfeeding process for primiparas is often accompanied by physical and psychological difficulties. Inability to achieve the correct breastfeeding position can lead to nipple cracks, inadequate nutrition for the baby, and decreased motivation to breastfeed .

In recent years, technological innovations and ergonomic support tools have been developed to improve the breastfeeding process. One of the ergonomic support tools used to facilitate the breastfeeding process is the breastfeeding arm sling. The breastfeeding arm sling aims to make the breastfeeding process more comfortable by supporting the mother's arm and ensuring that the baby is positioned more stably . In this regard, it is important to test new generation supportive breastfeeding equipment through evidence-based research.

On the other hand, the biological feeding position (laid-back breastfeeding) is a method that uses the effect of gravity to activate the baby's natural reflexes and allows the mother to breastfeed in a comfortable position. This position has been found to increase breastfeeding success, reduce nipple trauma, and facilitate milk flow, especially in primiparous women . However, there are limited studies in the literature suggesting that both methods can increase breastfeeding success.

This study aims to compare the effects of the breastfeeding support armrest and the biological feeding position on the breastfeeding process in primiparous women. Conducted within a randomised controlled design, this research aims to evaluate their effects on breastfeeding self-efficacy, breastfeeding success, and attitudes towards breastfeeding.

Interventions

  • Behavioral Biological Feeding Position
    Biological Feeding Position

Primary outcome measures

  • The Iowa Infant Feeding Attitudes Scale, [Time frame: 48 hours]
  • Postnatal Breastfeeding Self-Efficacy Scale-Short Form Breastfeeding: [Time frame: 2 day]
  • LATCH [Time frame: 2 day]

Eligibility criteria

Inclusion criteria

  • Ability to read and understand Turkish well
  • Applied within the first 72 hours after hospitalization
  • Delivered a healthy newborn
  • Age 18 years or older

Exclusion criteria

  • Communication difficulties
  • Inability to speak or understand Turkish

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07144358 · KahramanmaraşSIU11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗