Clinical trial NCT05697302: The Effect of Training and Follow-up Given According to the Health Promotion Model on Relactation Success
Official title: The Effect of Training and Follow-up Given to Mothers with 15 Day-4 Month-old Babies According to the Health Promotion Model on Relactation Success: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Health Promotion Model
Relactation
Lactation
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* Can read and write Turkish and has no speech impediment,
* Being between the ages of 18-45 and having given birth for the first time,
* Mother and baby not having any health problems that would prevent breastfeeding (medications used in cancer treatment in the mother, some epilepsy medications, psychotherapy medications, migraine medications, Parkinson's medications, some painkillers, radioactive iodine use, active tuberculosis, HIV infection; congenital anomaly, galactosemia disease, phenylketonuria disease, congenital metabolic disease such as urea cycle enzyme defect),
* Not breastfeeding for at least 2 weeks and at most 8 weeks (for mothers who have never breastfed)
* Decreased milk supply that causes babies to be fed with formula for more than 2 weeks (for mothers with low milk supply),
* Having breastfeeding problems that cause decreased milk supply (breast refusal, incorrect breastfeeding techniques, breast abscess... starting work early...). •Separation of the baby or mother due to hospitalization, A mother who is formula feeding her baby changes her mind,
* No use of drugs that will affect the amount of milk (galactagogues such as metoclopramide, domperidone),
* The mother can be reached by phone,
* The baby is at least 15 days old and at most 4 months old.

Exclusion Criteria:

* Adopted/non-biological babies,
* Any health condition that would prevent breastfeeding or breastfeeding in the mother or baby (medications used in cancer treatment, some epilepsy medications, psychotherapeutic medications, migraine medications, Parkinson's medications, some painkillers, radioactive iodine use, active tuberculosis, HIV infection in the mother; congenital anomaly in the baby, galactosemia disease, phenylketonuria disease, congenital metabolic disease such as urea cycle enzyme defect), Use of medication that would affect milk quantity (galactagogues such as metoclopramide, domperidone)
* Women participating in another study on breastfeeding during the study period will not be included in the study.

Primary outcomes:
measure: Determination of mothers' breastfeeding self-efficacy level
timeFrame: 4 months
measure: Relactation success
timeFrame: 4 months
measure: Determination of mothers' breastfeeding motivation
timeFrame: 4 months
measure: Determination of amount of breast milk the baby receives.
timeFrame: 4 months
measure: Breastfeeding diagnosis of mothers
timeFrame: 4 months
Secondary outcomes:
measure: Levels of satisfaction with the education and follow-up of mothers
timeFrame: 4 months
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Üniversitesi
Study officials:
affiliation: Erzincan Binali Yildirim Universitesi
name: Ayşe DAŞTAN YILMAZ
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Teknik University
name: Kıymet YEŞİLÇİÇEK ÇALIK
role: PRINCIPAL_INVESTIGATOR
References: