Primiparous WomenEBASBFPNCT07144358
Effectiveness of Breastfeeding Arm Sling and Biological Feeding Position in Primiparous Womenl
A study testing Biological Feeding Position in people with Primiparous Women, run by Hatice Gul OZTAS.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primiparous Women
- What is being tested?
- Biological Feeding Position
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ability to read and understand Turkish well
- Applied within the first 72 hours after hospitalization
- Delivered a healthy newborn
- Age 18 years or older
Who cannot join
- Communication difficulties
- Inability to speak or understand Turkish
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Breastfeeding Arm Sling and Biological Feeding Position in Primiparous Women: A Randomized Controlled Trial
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:
- Group receiving the Breastfeeding Arm Support group (n = 44)
- Group receiving the Biological Feeding Position (n = 44) Post-intervention post-tests will be administered to both groups, and the results will be compared.
Read the 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.
- Conditions
- Primiparous Women
- Being tested
- Biological Feeding Position
- Keywords
- Breastfeeding, biological nurturing,, breastfeeding arm sling, midwifery
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological Feeding PositionBehavioural
Biological Feeding Position
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Breastfeeding Arm Support group Receives: Behavioral: Biological Feeding Position |
| control group | Placebo comparator | education Receives: Behavioral: Biological Feeding Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Iowa Infant Feeding Attitudes Scale,
developed by De La Mora and Russell (1999), was designed to assess women's attitudes toward breastfeeding and predict breastfeeding duration and infant feeding method selection. The scale consists of 17 items on a 5-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree). Nine items in the scale contain negative statements about breastfeeding, while eight items contain positive statements about formula feeding. The scale's validity and reliability in Turkish were conducted by Ekşioğlu et al. (2016), and Cronbach's alpha was found to be 0.71 (Ekşioğlu et al., 2016).
Measured: 48 hours
Postnatal Breastfeeding Self-Efficacy Scale-Short Form Breastfeeding:
A 14-item short form of the 33-item scale, originally developed by Dennis and Faux9 to assess mothers' breastfeeding self-efficacy levels, was developed in 2003, and its Cronbach's alpha was found to be 0.94. Tokat Aluş and Okumuş18,19 found Cronbach's alpha to be 0.86 in the Turkish reliability and validity study of the short form of the Breastfeeding Self-Efficacy Scale, indicating its suitability for Turkish culture. In this study, the Cronbach's alpha value for the scale was 0.89. The Breastfeeding Self-Efficacy Short Form is a 5-point Likert-type scale (1 = Not at all confident to 5 = Always confident). The minimum score is 14, and the maximum score is 70. Higher scores indicate higher breastfeeding self-efficacy. The average administration time for the scale is 5-7 minutes.
Measured: 2 day
LATCH
Breastfeeding Diagnostic Measurement Tool The LATCH Breastfeeding Diagnostic and Assessment Scale was developed by Jensen and colleagues in 1994 (Jensen, Wallace, and Kelsay 1994). The Turkish validity and reliability of the scale was conducted by Yenal and Okumuş in 2003 (Yenal and Okumuş 2003). The LATCH scale assesses the baby's attachment to the breast (L), audibility of swallowing (A), nipple type (T), nipple comfort (C), and the way the baby is held (H) (Jensen et al. 1994). Each item ranges from 0 to 2 points, with the lowest possible score being 0 and the highest being 10. The scale has no cut-off point. A high score indicates high breastfeeding success, while a low score indicates a need for breastfeeding support. In the most recent Turkish validity and reliability study of the scale, the Cronbach's alpha was reported as 0.95 (Yenal and Okumuş 2003).
Measured: 2 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start20 Sep 2025 (estimated)
- Primary completion28 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primiparous WomenStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hatice Gul OZTAS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatice Gul OZTAS, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144358
- Sponsor's protocol ID
- KahramanmaraşSIU11
- Acronym
- EBASBFP
- Status last verified
- Aug 2025
- First submitted
- 17 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data because of institutional policies and protection of participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Breastfeeding Arm Sling and Biological Feeding Position in Primiparous Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07144358
- Acronym / sponsor ID
- EBASBFP / KahramanmaraşSIU11
- Conditions
- Primiparous Women
- Keywords
- Breastfeeding, biological nurturing,, breastfeeding arm sling, midwifery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Hatice Gul OZTASUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 28 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Aug 2025 (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.
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:
- Group receiving the Breastfeeding Arm Support group (n = 44)
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Biological Feeding PositionBreastfeeding Arm Support group |
| control group | Placebo comparator | Behavioral: Biological Feeding Positioneducation |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ability to read and understand Turkish well
- Applied within the first 72 hours after hospitalization
- Delivered a healthy newborn
- Age 18 years or older
Key exclusion criteria (2 listed)
- Communication difficulties
- Inability to speak or understand Turkish
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 |
|---|---|---|
| Biological Feeding PositionBiological Feeding Position | Behavioural | Experimental, control group |
Primary outcome
The Iowa Infant Feeding Attitudes Scale,
Time frame: 48 hours
developed by De La Mora and Russell (1999), was designed to assess women's attitudes toward breastfeeding and predict breastfeeding duration and infant feeding method selection. The scale consists of 17 items on a 5-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree). Nine items in the scale contain negative statements about breastfeeding, while eight items contain positive statements about formula feeding. The scale's validity and reliability in Turkish were conducted by Ekşioğlu et al. (2016), and Cronbach's alpha was found to be 0.71 (Ekşioğlu et al., 2016).
Postnatal Breastfeeding Self-Efficacy Scale-Short Form Breastfeeding:
Time frame: 2 day
A 14-item short form of the 33-item scale, originally developed by Dennis and Faux9 to assess mothers' breastfeeding self-efficacy levels, was developed in 2003, and its Cronbach's alpha was found to be 0.94. Tokat Aluş and Okumuş18,19 found Cronbach's alpha to be 0.86 in the Turkish reliability and validity study of the short form of the Breastfeeding Self-Efficacy Scale, indicating its suitability for Turkish culture. In this study, the Cronbach's alpha value for the scale was 0.89. The Breastfeeding Self-Efficacy Short Form is a 5-point Likert-type scale (1 = Not at all confident to 5 = Always confident). The minimum score is 14, and the maximum score is 70. Higher scores indicate higher breastfeeding self-efficacy. The average administration time for the scale is 5-7 minutes.
LATCH
Time frame: 2 day
Breastfeeding Diagnostic Measurement Tool The LATCH Breastfeeding Diagnostic and Assessment Scale was developed by Jensen and colleagues in 1994 (Jensen, Wallace, and Kelsay 1994). The Turkish validity and reliability of the scale was conducted by Yenal and Okumuş in 2003 (Yenal and Okumuş 2003). The LATCH scale assesses the baby's attachment to the breast (L), audibility of swallowing (A), nipple type (T), nipple comfort (C), and the way the baby is held (H) (Jensen et al. 1994). Each item ranges from 0 to 2 points, with the lowest possible score being 0 and the highest being 10. The scale has no cut-off point. A high score indicates high breastfeeding success, while a low score indicates a need for breastfeeding support. In the most recent Turkish validity and reliability study of the scale, the Cronbach's alpha was reported as 0.95 (Yenal and Okumuş 2003).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data because of institutional policies and protection of participant confidentiality.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Biological Feeding Position in people with Primiparous Women, run by Hatice Gul OZTAS.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HATİCE GÜL ÖZTAŞ, DİRECTOR (05428267629, haticeguloztas@ksu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Iowa Infant Feeding Attitudes Scale, (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2025.