Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT05697302
Status:
COMPLETED
Last Update Posted:
2025-01-28
First Post:
2023-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Training and Follow-up Given According to the Health Promotion Model on Relactation Success
Sponsor:
Karadeniz Technical University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: