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NCT05697302 | Completed | Breastfeeding

The Effect of Training and Follow-up Given According to the Health Promotion Model on Relactation Success
Sponsor:

Karadeniz Technical University

Information provided by (Responsible Party):

Ayşe Daştan Yılmaz

Brief Summary:

The process of restarting or increasing lactation in a mother who wants to breastfeed her baby again after the termination of breastfeeding or decrease in lactation is called relactation. The research type was planned as a pretest-posttest randomized controlled experimental study. The research will be carried out between January 2023 and December 2023, with mothers in need of relactation identified in Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital and 7 Family Health Centers in Erzincan city center. The study will be face-to-face, twice a week in the first two weeks of the 1st month, once a week in the other weeks, and once every two weeks in the 2nd month, in a total of 2 months, and will consist of 8 interviews. The number of these meetings may increase depending on the situation of the mother and the baby. Interviews will be held at mothers' homes or at FHCs (whichever they prefer). During the research, based on the SGM, training on the importance of breast milk and breastfeeding, its benefits and relactation techniques, written and visual training materials containing these topics, online messages and online live support by calling the researcher by video or audio when requested, and the breastfeeding process will be supported. The sample will consist of 70 mothers, 35 of whom are in the intervention group and 35 of them are in the control group, who meet the research criteria. In data collection, the World Health Organization (WHO) Simple Routine Evaluation and Breastfeeding Assistance form, Personal Information Form, Breastfeeding Self-Efficacy Scale (EÖYÖ), Breastfeeding Diagnostic Measurement Tool (LATCH) and IMDAT- Scoring System for the Amount of Breastmilk Ingested by the Baby, Breastfeeding Motivation Scale (EMO) and VAS satisfaction scale will be used. Study; The aim of this study was to determine the effect of the education and follow-up given to mothers who need help with relactation on the success of relaxation. The data will be evaluated with the IBM SPSS (Statistical Package for Social Sciences) 22.0 package program. Frequency and percentage will be used in the analysis of the data. In addition, necessary analyzes will be made after testing whether the data obtained comply with the normal distribution. P<0.05 will be used as the 95% confidence interval and significance level in the results.

Condition or disease

Breastfeeding

Intervention/treatment

Education

Follow-up

Referral to Lactation and Relactation Polyclinic

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 70 participants
Masking : Double
Primary Purpose : Supportive Care
Official Title : The Effect of Training and Follow-up Given to Mothers With 0-4 Month-old Babies According to the Health Promotion Model on Relactation Success: A Randomized Controlled Study
Actual Study Start Date : July 3, 2023
Estimated Primary Completion Date : January 30, 2024
Estimated Study Completion Date : February 1, 2024
Arm Intervention/treatment

Experimental: Relactation

Behavioral: Education

Behavioral: Follow-up

Active Comparator: Control

Behavioral: Follow-up

Behavioral: Referral to Lactation and Relactation Polyclinic
Ages Eligible for Study: 18 Years to 49 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • Can read and write Turkish and have no disability in speaking,
  • 18 years and over,
  • The mother and the baby do not have any health condition that would prevent breastfeeding (drugs used in the treatment of cancer in the mother, some epilepsy drugs, psychotherapeutic drugs, migraine drugs, Parkinson's drugs, some analgesics, use of radioactive iodine, active tuberculosis, HIV infection; congenital anomaly, galactosemia disease, phenylketonuria disease, congenital metabolic disease such as urea cycle enzyme defect),
  • Absence of breastfeeding for at least 2 weeks, maximum 8 weeks (for mothers who have never breastfed)
  • Decreased lactation that causes babies to be given formula for more than 2 weeks (for mothers with low milk),
  • Those who have breastfeeding problems that cause decreased lactation (breast problems such as breast refusal, incorrect breastfeeding techniques, breast abscess…early starting work…).
  • Separation of the baby or mother due to hospitalization, A mother who feeds her baby with formula changes her mind,
  • Not using drugs that will affect the amount of milk (galactagogues such as metoclopramide, domperidone),
  • The mother can be reached by phone,
  • The baby is at most 4 months old.
Exclusion Criteria
  • Adopted/non-biological babies,
  • Any health condition in the mother and baby that will prevent breastfeeding or breastfeeding (drugs used in the treatment of cancer, some epilepsy drugs, psychotherapeutic drugs, migraine drugs, Parkinson's drugs, some analgesics, radioactive iodine use, active tuberculosis, HIV infection in the mother; congenital metabolic disease such as congenital anomaly, galactosemia disease, phenylketonuria disease, urea cycle enzyme defect in the baby), Use of drugs that will affect the amount of milk (galactagogues such as metoclopramide, domperidone)
  • Women who participated in another breastfeeding-related study during the study period will not be included in the study.
The Effect of Training and Follow-up Given According to the Health Promotion Model on Relactation Success

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The Effect of Training and Follow-up Given According to the Health Promotion Model on Relactation Success

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Turkey,

Karadeniz Technical University

Trabzon, Turkey,