- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05350605
The Effect of Breastfeeding Position Education on Breastfeeding
The Effect of Different Breastfeeding Position Education With Lactation Simulation Model on Breastfeeding
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34865
- Recruiting
- Marmara Univercity
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Contact:
- Dilek Coşkuner Potur, Assoc. Prof, PhD RN
- Phone Number: +905052753495
- Email: dilekcp@yahoo.com
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Contact:
- Ayşenur Durmuş, Research Asistant
- Phone Number: 05447755507
- Email: aysenurdurmus@kastamonu.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Diseases in which breastfeeding is a problem
- Baby with anomalies
- Cesarean births
- Patients admitted to neonatal intensive care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: Laid back breastfeding position education group
Breastfeeding 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.
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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.
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Experimental: Experimental: Upright breastfeeding position education group
Breastfeeding education will be given to pregnant women in the upright breastfeeding position group, which includes the upright breastfeeding position with a lactation simulation model.
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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.
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No Intervention: No Intervention: Control Group
Mothers in the control group will receive routine hospital care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Iowa Infant Feeding Attitude Scale
Time Frame: Measurement for each group at the third encounter (10th day after birth).
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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.
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Measurement for each group at the third encounter (10th day after birth).
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Breastfeeding Self-Efficacy Scale
Time Frame: Measurement for each group at the third encounter (10th day after birth).
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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.
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Measurement for each group at the third encounter (10th day after birth).
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LATCH
Time Frame: Measurement for each group at the third encounter (10th day after birth).
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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. |
Measurement for each group at the third encounter (10th day after birth).
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Visual Analogue Scale
Time Frame: Measurement for each group at the third encounter (10th day after birth).
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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.
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Measurement for each group at the third encounter (10th day after birth).
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IMDAT
Time Frame: Measurement for each group at the third encounter (10th day after birth).
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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.
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Measurement for each group at the third encounter (10th day after birth).
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Breast Problems Evaluation Form
Time Frame: Measurement for each group at the third encounter (10th day after birth).
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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
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Measurement for each group at the third encounter (10th day after birth).
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Postpartum Breastfeeding Follow-Up Form
Time Frame: Measurement for each group at the third encounter (10th day after birth).
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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.
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Measurement for each group at the third encounter (10th day after birth).
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- Colson S. Biological Nurturing: the laid-back breastfeeding revolution. Midwifery Today Int Midwife. 2012 Spring;(101):9-11, 66. No abstract available.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 125 (Norgine)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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