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

NCT ID: NCT05697302

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-01-04

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.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Relactation

Group Type: EXPERIMENTAL

Education

Intervention Type: BEHAVIORAL

Interviews will be held twice a week in the first two weeks of the first month, once a week in the following weeks, and once every two weeks in the second month, 8 times in a total of 2 months. The number of 8 interviews planned in the research may increase specifically for the situation of the mother and the baby. Interviews will be held at the mothers' homes or at the Family Health Center. An individualized message will be sent to mothers, two days a week, in accordance with their mobile communication tool, relactation needs. In addition, if the mothers request, they can call the researcher via mobile communication via video or voice and receive live support regarding their questions and questions.

Follow-up

Intervention Type: BEHAVIORAL

Among the data collection forms, LATCH-Breastfeeding Diagnostic Scale and IMDAT-The Baby's Breastmilk Scoring System will be applied at each interview, and the Breastfeeding Self-Efficacy Scale and Breastfeeding Motivation Scale will be applied at the first interview, at the end of the 1st month and at the end of the 2nd month. Mother interviews will be held in their homes or at the Family Health Center (whichever they prefer). At each meeting, an appointment schedule will be made for the next meeting and this information will be shared with the mothers in writing.

Control

Group Type: ACTIVE_COMPARATOR

Follow-up

Intervention Type: BEHAVIORAL

Among the data collection forms, LATCH-Breastfeeding Diagnostic Scale and IMDAT-The Baby's Breastmilk Scoring System will be applied at each interview, and the Breastfeeding Self-Efficacy Scale and Breastfeeding Motivation Scale will be applied at the first interview, at the end of the 1st month and at the end of the 2nd month. Mother interviews will be held in their homes or at the Family Health Center (whichever they prefer). At each meeting, an appointment schedule will be made for the next meeting and this information will be shared with the mothers in writing.

Referral to Lactation and Relactation Polyclinic

Intervention Type: BEHAVIORAL

Due to the nature of the research, mothers in the control group will not be given any training, and they will be referred to the Lactation and Relaxation Polyclinic in Erzincan Mengücek Gazi Training and Research Hospital.

Interventions

Education

Interviews will be held twice a week in the first two weeks of the first month, once a week in the following weeks, and once every two weeks in the second month, 8 times in a total of 2 months. The number of 8 interviews planned in the research may increase specifically for the situation of the mother and the baby. Interviews will be held at the mothers' homes or at the Family Health Center. An individualized message will be sent to mothers, two days a week, in accordance with their mobile communication tool, relactation needs. In addition, if the mothers request, they can call the researcher via mobile communication via video or voice and receive live support regarding their questions and questions.

Intervention Type: BEHAVIORAL

Follow-up

Among the data collection forms, LATCH-Breastfeeding Diagnostic Scale and IMDAT-The Baby's Breastmilk Scoring System will be applied at each interview, and the Breastfeeding Self-Efficacy Scale and Breastfeeding Motivation Scale will be applied at the first interview, at the end of the 1st month and at the end of the 2nd month. Mother interviews will be held in their homes or at the Family Health Center (whichever they prefer). At each meeting, an appointment schedule will be made for the next meeting and this information will be shared with the mothers in writing.

Intervention Type: BEHAVIORAL

Referral to Lactation and Relactation Polyclinic

Due to the nature of the research, mothers in the control group will not be given any training, and they will be referred to the Lactation and Relaxation Polyclinic in Erzincan Mengücek Gazi Training and Research Hospital.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Karadeniz Technical University

OTHER

Sponsor Role: lead

Responsible Party

Ayşe Daştan Yılmaz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşe DAŞTAN YILMAZ

Role: PRINCIPAL_INVESTIGATOR

Erzincan Binali Yildirim Universitesi

Kıymet YEŞİLÇİÇEK ÇALIK

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Teknik University

Locations

Karadeniz Teknik Üniversitesi

Trabzon, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

TDK-2023-10842

Identifier Type: -

Identifier Source: org_study_id