Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT06277856
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2023-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peer Interaction of Primiparas Sharing a Room With Multiparas With Successful Breastfeeding Experience
Sponsor:
Ege University
Organization:
Study Overview
Official Title:
The Effect of Peer Interaction on Breastfeeding Self-Efficacy of Primiparas Sharing the Same Room With Mothers With Successful Postpartum Breastfeeding Experience; Randomised Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-02
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 World Health Organization (WHO) states that peer support breastfeeding education programs are effective interventions for improving breastfeeding outcomes. In this context, the WHO's Global Strategy for Infant and Young Child Feeding recommends the implementation of "lay health worker peer counselors" and "mother-to-mother support groups" to promote and support breastfeeding. The tenth step of the Baby-Friendly Hospital Initiative also emphasizes the importance of mother-to-mother support as a successful intervention for breastfeeding. However, in our country, there have been limited studies and efforts to provide peer education and support for breastfeeding. Although various valuable studies using different educational techniques have been conducted to improve breastfeeding rates, the integration of these programs into routine clinical practice remains insufficient. This study aims to implement a peer interactive education program in postpartum rooms to bring experienced and inexperienced mothers together, as part of the hospital routine. The project will focus on the development and implementation of a peer interactive education program and will investigate its impact on the breastfeeding self-efficacy of primiparous mothers. The research follows a two-group pre-test and post-test design, is non-blind, and uses randomized controlled methodology. Initially, the hospital rooms will be rearranged to accommodate the implementation of the peer support breastfeeding education module. Researcher midwives will provide a brief training to experienced peer educator mothers who have previously breastfed.Afterwards, the peer education program will be conducted when the experienced mother and primiparous mother are together in the room. The study emphasizes improving early postpartum breastfeeding success and aims to make peer interaction a routine part of hospital practice. The feasibility of implementing peer education in hospitals will be evaluated, considering its simplicity and practicality. The impact of peer interactions on the mother's breastfeeding self-efficacy and attitudes towards breastfeeding will be assessed.
Overall, this research aims to improve breastfeeding rates by implementing peer support programs in hospital settings and evaluating the outcomes of peer interactions in terms of the mother's breastfeeding self-efficacy and attitudes towards breastfeeding.
Overall, this research aims to improve breastfeeding rates by implementing peer support programs in hospital settings and evaluating the outcomes of peer interactions in terms of the mother's breastfeeding self-efficacy and attitudes towards breastfeeding.
Detailed Description:
Study Design: This project was planned as a two-group, non-blinded randomised controlled trial.
Ethical approval was obtained from the Medical Research Ethics Committee of a university for the conduct of the study (Date: 08.11.2022, Decision no: 22-11T/25).
Population and Sample of the Study: Mothers who were hospitalised in Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital obstetrics and gynaecology ward, who met the inclusion criteria and volunteered to participate in the study will constitute the population of the study. A priori power analysis was performed using G.Power 3.1.9.2 package programme to determine the sample size. In the calculation made, with the assumption of 0.5 effect value for 80% power at 95% confidence interval, it was calculated as 128 women, 64 for the group in which peer supported breastfeeding education will be applied and 64 for the group in which standard education will be applied. In order to ensure homogeneity between the groups and to eliminate selection bias, the "block randomisation" method, one of the fixed probability randomisation methods, will be used in the study and women who meet the inclusion criteria will be distributed to the intervention and control groups.
Hypotheses of the study
1. H1: Breastfeeding self-efficacy of mothers who receive peer interaction after birth will be higher than the control group.
2. H1: The level of exclusive breastfeeding of mothers receiving peer interaction will be higher than that of mothers in the control group.
Ethical approval was obtained from the Medical Research Ethics Committee of a university for the conduct of the study (Date: 08.11.2022, Decision no: 22-11T/25).
Population and Sample of the Study: Mothers who were hospitalised in Izmir Democracy University Buca Seyfi Demirsoy Training and Research Hospital obstetrics and gynaecology ward, who met the inclusion criteria and volunteered to participate in the study will constitute the population of the study. A priori power analysis was performed using G.Power 3.1.9.2 package programme to determine the sample size. In the calculation made, with the assumption of 0.5 effect value for 80% power at 95% confidence interval, it was calculated as 128 women, 64 for the group in which peer supported breastfeeding education will be applied and 64 for the group in which standard education will be applied. In order to ensure homogeneity between the groups and to eliminate selection bias, the "block randomisation" method, one of the fixed probability randomisation methods, will be used in the study and women who meet the inclusion criteria will be distributed to the intervention and control groups.
Hypotheses of the study
1. H1: Breastfeeding self-efficacy of mothers who receive peer interaction after birth will be higher than the control group.
2. H1: The level of exclusive breastfeeding of mothers receiving peer interaction will be higher than that of mothers in the control group.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Ayse Akyar | OTHER | Ege University | View |