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Breastfeeding EducationNCT05350605

The Effect of Breastfeeding Position Education on Breastfeeding

A study testing Breastfeeding position education with lactation simulation model in people with Breastfeeding Education, run by Marmara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Planned for the purpose to evaluate, breast problems (nipple fissure, nipple pain), breastfeeding self-efficacy, breastfeeding success, and infant feeding attitude of mothers by given breastfeeding education with a laid back (semi-sitting or semi-lying) and upright position (sitting upright) using lactation simulation… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breastfeeding Education
What is being tested?
Breastfeeding position education with lactation simulation model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2022to 1 May 2023
Phase
Interventional
Are there results?
None posted in the registry

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 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pregnant Women
  • Primiparous
  • Women aged 18-35 years
  • Sign the informed consent form
  • Those planning a vaginal birth
  • Absence of a health problem that prevents breastfeeding
  • Having a healthy baby at term

Who cannot join

  • Diseases in which breastfeeding is a problem
  • Baby with anomalies
  • Cesarean births
  • Patients admitted to neonatal intensive care

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting
  • Marmara Univercity

    Istanbul, 34865

    Dilek Coşkuner Potur, Assoc. Prof, PhD RN, +905052753495, dilekcp@yahoo.com

    Ayşenur Durmuş, Research Asistant, 05447755507, aysenurdurmus@kastamonu.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Different Breastfeeding Position Education With Lactation Simulation Model on Breastfeeding

Planned for the purpose to evaluate, breast problems (nipple fissure, nipple pain), breastfeeding self-efficacy, breastfeeding success, and infant feeding attitude of mothers by given breastfeeding education with a laid back (semi-sitting or semi-lying) and upright position (sitting upright) using lactation simulation model.

Read the detailed description

This study aims to increase breastfeeding success, breastfeeding self-efficacy and effective infant feeding, reduce breast problems, and to affect positively the mother's infant feeding attitude of breastfeeding positions taught to mothers in the antenatal period with the lactation simulation model. Also, it carried out to reveal the importance of midwife/nurse support and education that starts in the antenatal period and continues in the postpartum period, by increasing the adaptation of the mother to the breastfeeding process with the education given in the antenatal period, aims to contribute to the initiation and maintenance of breastfeeding. his study will be conducted as a randomized controlled experimental study. The population of the study will be primiparous pregnant women who applied to Kastamonu Education and Research Hospital between 01/05/2022-01/05/2023. The sample will consist of 105 pregnant women (35 pregnant women for each group) who met the inclusion criteria and accepted to participate in the study. The mothers in the experimental group will be trained with the lactation simulation model during the antenatal care follow-ups in the last trimester of their pregnancy (one group laid back and another group breastfeeding position education) and the necessary forms will be filled in their first interview, A second interview will be held within the first 24 hours after the birth, and the breastfeeding position taught to the mothers will be shown in practice by supporting the mother, and the necessary forms will be filled. The third meeting will be held between 7.-10. days of postpartum and the necessary forms will be filled. The mothers in the control group will be interviewed during the antenatal care follow-ups in the last trimester of their pregnancy. Mothers in the control group will receive routine care and routine breastfeeding education both in the prenatal and postnatal period. Necessary forms will be filled with the mothers in the control group by meeting in the first 24 hours and on the days 7th-10th. of postpartum. Personal information form, breastfeeding self-efficacy scale, Iowa infant feeding attitude scale, LATCH, visual comparison scale, postpartum breastfeeding follow-up form, breast problems evaluation form and IMDAT form will be used as data collection tools. Breastfeeding has numerous benefits for mother and baby. While it prevents many diseases such as otitis media, respiratory tract infections, obesity, sudden infant death syndrome, allergies and diabetes in infants, it neurodevelopmentally contributes positive effects to the development of the baby. Postpartum depression, cardiovascular diseases, diabetes, breast cancer, ovarian cancer and osteoporosis rates are lower in mothers who breastfeed for more than 1 year. The fact that there is less feeding cost contributes to the family economically.

Being tested
Breastfeeding position education with lactation simulation model
Keywords
Breastfeeding Education, Lactation Simulation Model, Nipple problems, Breastfeeding self-efficacy, Breastfeeding success

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breastfeeding position education with lactation simulation modelBehavioural

    pregnant women will receive training with a lactation simulation model once in the last trimester.The pregnant woman will wear the lactation simulation model during the education period and show what she has learned practically on the model.Mothers who have given birth will be supported to practice the breastfeeding position in the postpartum service.

Study groups in NCT05350605
Study groupRoleWhat they receive
Experimental: Laid back breastfeding position education groupExperimentalBreastfeeding education will be given to pregnant women in the laid-back breastfeeding position group, which includes the laid back breastfeeding position with a lactation simulation model.
Receives: Behavioral: Breastfeeding position education with lactation simulation model
Experimental: Upright breastfeeding position education groupExperimentalBreastfeeding education will be given to pregnant women in the upright breastfeeding position group, which includes the upright breastfeeding position with a lactation simulation model.
Receives: Behavioral: Breastfeeding position education with lactation simulation model
No Intervention: Control GroupNo interventionMothers in the control group will receive routine hospital care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Iowa Infant Feeding Attitude Scale

    It is a scale that evaluates the attitudes of women towards breastfeeding and the choice of infant feeding method, as well as the duration of breastfeeding.The scale consists of a 5-point Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree) and 17 items. While 9 items in the scale affirm the issue of breastfeeding, 8 items contain positive statements about formula feeding. Formula nutrition items are scored in reverse (1=5, 2=4, 4=2 and 5=1). The total attitude score ranges from 17 (reflecting a positive attitude towards bottle feeding) to 85 points (reflecting a positive attitude towards breastfeeding). The scale has no cut-off value, high scores indicate a positive breastfeeding attitude. In the literature, those with a score between 70-85 were considered determined to breastfeed. If the score is between 49-69, the undecided group; Those with a score between 17-48 were accepted as having a tendency to feed with formula.

    Measured: Measurement for each group at the third encounter (10th day after birth).

  2. Breastfeeding Self-Efficacy Scale

    Breastfeeding self-efficacy levels of mothers and their self-confidence in breastfeeding are measured using the breastfeeding self-efficacy scale. The Breastfeeding Self-Efficacy Scale (short form) consists of 14 items that measure the mother's breastfeeding self-efficacy. The maximum score that can be obtained from the scale is 70, and the minimum score is 14.High scores from the scale indicate high breastfeeding self-efficacy. The scale is 5-point Likert type; 1 = Not at all sure, 2 = Not very sure, 3 = Sometimes I am sure, 4 = I am sure, 5 = I am very sure.

    Measured: Measurement for each group at the third encounter (10th day after birth).

  3. LATCH

    Observation and evaluation of mothers' breastfeeding success is measured using the LATCH scale.The LATCH Breastfeeding Diagnostic and Evaluation Scale is a scale filled by the researcher through observation.

    L: (Latch on the brest)) A: (Audible Swallowing) T: (Type of Nipple) C: (Comfort of Breast/ Nipple) H: (Hold/ Position)

    LATCH consists of the combination of the first letters of the English equivalent of the five criteria defined above. Each item is evaluated between 0-2 points. The lowest score that can be obtained from the entire scale is 0 and the highest score is 10. The scale has no breakpoints. The low score on the scale indicates the need for active intervention, support and follow-up after discharge in breastfeeding. The higher the LATCH Breastfeeding Diagnosis and Evaluation Scale score, the higher the success of breastfeeding.

    Measured: Measurement for each group at the third encounter (10th day after birth).

  4. Visual Analogue Scale

    It measures the severity of pain in individuals.This distance, which is usually measured in centimeters, is reported as "points". Numbers from 0 to 10 are written on the two ends of a 10 cm line on the parameter to be evaluated, and the patient is asked at what level of pain he is.The patient marks her own pain on a 10 cm ruler, with painlessness on one end and the most severe pain on the other. As the VAS value approaches 10, the pain is considered to be very severe, and as it approaches 0, the pain decreases.

    Measured: Measurement for each group at the third encounter (10th day after birth).

  5. IMDAT

    The amount of breast milk the baby receives is measured using the IMDAT scale.The form consists of 5 sections: the weight of the babies, their satisfaction, the frequency and characteristics of urinating and defecation, and the condition of the mother's breasts. With the form, the features of each situation are evaluated as 0, 1, 2 points, and the maximum total score that can be obtained is 10. A score of 8-10 is considered the best breast milk intake, and a score of 0-7 is considered insufficient.

    Measured: Measurement for each group at the third encounter (10th day after birth).

  6. Breast Problems Evaluation Form

    Problems such as pain, cracks and redness in the breast are measured using the breast evaluation form.The form consists of 9 questions questioning the breast problems of the mothers in the first 10 days postpartum. The form will be collected by the researcher through a face-to-face interview

    Measured: Measurement for each group at the third encounter (10th day after birth).

  7. Postpartum Breastfeeding Follow-Up Form

    This form was developed by the researcher by scanning the literature. The form consists of 13 questions questioning the postpartum breastfeeding status of mothers. The form will be collected by the researcher through a face-to-face interview.

    Measured: Measurement for each group at the third encounter (10th day after birth).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start1 May 2022 (estimated)
  3. Primary completion1 Aug 2022 (estimated)
  4. Study completion1 May 2023 (estimated)

Resources

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
Parallel groups
Model description
Randomized Controlled Experimental Design
Masking
None (open label)
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05350605
Sponsor's protocol ID
125
Status last verified
Mar 2022
First submitted
22 Mar 2022
Last updated
28 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The research article will be shared after publication

Publications

  • Coca KP, Marcacine KO, Gamba MA, Correa L, Aranha AC, Abrao AC. Efficacy of Low-Level Laser Therapy in Relieving Nipple Pain in Breastfeeding Women: A Triple-Blind, Randomized, Controlled Trial. Pain Manag Nurs. 2016 Aug;17(4):281-9. doi: 10.1016/j.pmn.2016.05.003. Epub 2016 Jun 27.

    PubMed 27363734
  • Colson S. Biological Nurturing: the laid-back breastfeeding revolution. Midwifery Today Int Midwife. 2012 Spring;(101):9-11, 66. No abstract available.

    PubMed 22486009
  • Mirghafourvand M, Kamalifard M, Ranjbar F, Gordani N. Relationship of breastfeeding self-efficacy with quality of life in Iranian breastfeeding mothers. J Matern Fetal Neonatal Med. 2018 Oct;31(20):2721-2728. doi: 10.1080/14767058.2017.1354368. Epub 2017 Jul 20.

    PubMed 28728490
  • Kestler-Peleg M, Shamir-Dardikman M, Hermoni D, Ginzburg K. Breastfeeding motivation and Self-Determination Theory. Soc Sci Med. 2015 Nov;144:19-27. doi: 10.1016/j.socscimed.2015.09.006. Epub 2015 Sep 8.

    PubMed 26372935
  • Kilci H, Coban A. The Correlation Between Breastfeeding Success in the Early Postpartum Period and the Perception of Self-Efficacy in Breastfeeding and Breast Problems in the Late Postpartum. Breastfeed Med. 2016 May;11:188-95. doi: 10.1089/bfm.2015.0046. Epub 2016 Mar 30.

    PubMed 27027656
  • McFadden A, Gavine A, Renfrew MJ, Wade A, Buchanan P, Taylor JL, Veitch E, Rennie AM, Crowther SA, Neiman S, MacGillivray S. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2017 Feb 28;2(2):CD001141. doi: 10.1002/14651858.CD001141.pub5.

    PubMed 28244064
  • Milinco M, Travan L, Cattaneo A, Knowles A, Sola MV, Causin E, Cortivo C, Degrassi M, Di Tommaso F, Verardi G, Dipietro L, Piazza M, Scolz S, Rossetto M, Ronfani L; Trieste BN (Biological Nurturing) Investigators. Effectiveness of biological nurturing on early breastfeeding problems: a randomized controlled trial. Int Breastfeed J. 2020 Apr 5;15(1):21. doi: 10.1186/s13006-020-00261-4.

    PubMed 32248838
  • Cagan ES, Solmaz E, Ozayabakan R, Balci R. The Effect of Paternal Skin-to-Skin Contact After Cesarean Section on the Breastfeeding Process: Randomized Controlled Study. J Perinat Neonatal Nurs. 2026 Apr-Jun 01;40(2):103-111. doi: 10.1097/JPN.0000000000000947. Epub 2025 Aug 29.

    PubMed 42030106
  • Durmus A, Potur DC. The Effect of Training on Different Breastfeeding Positions With Lactation Simulation Model on Breastfeeding. J Perinat Neonatal Nurs. 2026 Apr-Jun 01;40(2):91-102. doi: 10.1097/JPN.0000000000000944. Epub 2025 Aug 26.

    PubMed 40862533

Questions about this trial

What is this clinical trial studying?

A study testing Breastfeeding position education with lactation simulation model in people with Breastfeeding Education, run by Marmara University at 1 site in Turkey (Türkiye).

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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Iowa Infant Feeding Attitude Scale (time frame: Measurement for each group at the third encounter (10th day after birth).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05350605, which also lists 9 linked publications.

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 28 Apr 2022.

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