Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 10:04 PM
Study NCT ID:
NCT07144358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Breastfeeding Arm Sling and Biological Feeding Position in Primiparous Womenl
Sponsor:
Hatice Gul OZTAS
Organization:
Study Overview
Official Title:
Effectiveness of Breastfeeding Arm Sling and Biological Feeding Position in Primiparous Women: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EBASBFP
Brief Summary:
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: