Efficacy of a Nursing Intervention in First-time Mothers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-02

Study Completion Date

2020-02-01

Brief Summary

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Experimental study will determine the efficacy of nursing intervention named Maternal support to become first-time mothers based on the theory of Ramona Mercer. Sequential explanatory design will be used. It is a mixed design with approach quantitative and qualitative in order to obtain a better approach of the phenomen. The approach quantitative will be randomized controlled clinical trial. The qualitative analysis of the content will be done according to Bardin.

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Detailed Description

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Taking into account the scientific literature related to studies in first-time mothers with healthy newborns, it can be concluded that the limited success of interventions that have been made suggests that the main areas of becoming a mother have not been addressed, either as part of the content or process of the interventions. This study will be conducted in 24 months. The sample size calculated will be 74 first-time mothers in total, which are allocated in two groups, intervention and control. Each group with 37 mothers.

Conditions

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Mothers First Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The assigment of the mothers to each group will be like that: The allocation will be generated in the Epidat 4.1 program. This will be done by blocks in groups of equal size, randomized 1: 1, control and intervention group. The generation will be given by an statistician who will not perform the intervention, nor the initial or final evaluations.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Masking will be done to participant and outcomes assessor

Study Groups

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Maternal support to become mother

Maternal support to become mother: is an intervention based on the mid-range nursing theory of Ramona Mercer, whose purpose is to empower first-time mothers in their new maternal role, favoring the mother-child bond, strengthening social support and maternal self-efficacy, consists of:

1. Four Home visits , in the first week; first month of baby life; at three months; and the fourth postpartum month.
2. Four Educational sessions and support sessions for maternal empowerment in each home visit.
3. Telephone follow-up: at 15 days; a month and a half; at two and a half months; and three and a half months postpartum.

Group Type EXPERIMENTAL

Maternal support to become mother

Intervention Type BEHAVIORAL

"AMACOM-PRI": Apoyo Materno para Convertirse en Madre - Primerizas. Maternal support to become first-time mothers is an intervention based on the mid-range nursing theory of Ramona Mercer, whose purpose is to empower first-time mothers in their new maternal role, favoring the mother-child bond, strengthening social support and maternal self-efficacy, consists of.

1. Four Home visits , in the first week; first month of baby life; at three months; and the fourth postpartum month.
2. Four Educational sessions and support sessions for maternal empowerment in each home visit.
3. Telephone follow-up: at 15 days; a month and a half; at two and a half months; and three and a half months postpartum.

Control group: usual Care

The participants will receive the usual education about the care of the mother during the puerperium, the care of the newborn, including breastfeeding.

Group Type ACTIVE_COMPARATOR

Control Group: usual care

Intervention Type BEHAVIORAL

This intervention is usual care, which consists of:

1. care of the mother and her newborn during the puerperium
2. Teaching about breastfeeding.

Interventions

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Maternal support to become mother

"AMACOM-PRI": Apoyo Materno para Convertirse en Madre - Primerizas. Maternal support to become first-time mothers is an intervention based on the mid-range nursing theory of Ramona Mercer, whose purpose is to empower first-time mothers in their new maternal role, favoring the mother-child bond, strengthening social support and maternal self-efficacy, consists of.

1. Four Home visits , in the first week; first month of baby life; at three months; and the fourth postpartum month.
2. Four Educational sessions and support sessions for maternal empowerment in each home visit.
3. Telephone follow-up: at 15 days; a month and a half; at two and a half months; and three and a half months postpartum.

Intervention Type BEHAVIORAL

Control Group: usual care

This intervention is usual care, which consists of:

1. care of the mother and her newborn during the puerperium
2. Teaching about breastfeeding.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Postpartum stage (for vaginal or for cesarean delivery)
* Mother of a healthy full term newborn.
* First-time mother.
* Self-declared support by her couple.
* Mother living in Bucaramanga metropolitan area

Exclusion Criteria

* Multiple pregnancy.
* Mothers who cannot read or write.
* Diagnosis of postpartum depression, mental disorders, behavioral disorders.
* Mothers admitted to the intensive care unit after childbirth.
* Mothers with newborns hospitalized in the intensive care unit, intermediate care or minimal care.

Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes