NCT05350605

Brief 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 model.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 28, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

March 22, 2022

Last Update Submit

April 27, 2022

Conditions

Keywords

Breastfeeding EducationLactation Simulation ModelNipple problemsBreastfeeding self-efficacyBreastfeeding success

Outcome Measures

Primary Outcomes (7)

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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

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

  • 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.

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

Study Arms (3)

Experimental: Laid back breastfeding position education group

EXPERIMENTAL

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.

Behavioral: Breastfeeding position education with lactation simulation model

Experimental: Upright breastfeeding position education group

EXPERIMENTAL

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.

Behavioral: Breastfeeding position education with lactation simulation model

No Intervention: Control Group

NO INTERVENTION

Mothers in the control group will receive routine hospital care

Interventions

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.

Experimental: Laid back breastfeding position education groupExperimental: Upright breastfeeding position education group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen who are pregnancy
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara Univercity

Istanbul, 34865, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • 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.

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

    PMID: 22486009BACKGROUND
  • 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.

    PMID: 28728490BACKGROUND
  • 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.

    PMID: 26372935BACKGROUND
  • 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.

    PMID: 27027656BACKGROUND
  • 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.

    PMID: 28244064BACKGROUND
  • 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.

    PMID: 32248838BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized Controlled Experimental Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 28, 2022

Study Start

May 1, 2022

Primary Completion

August 1, 2022

Study Completion

May 1, 2023

Last Updated

April 28, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

The research article will be shared after publication

Locations