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Clinical Trials/NCT03594526
NCT03594526
Completed
N/A

Efficacy of a Nursing Intervention in the Process of Becoming a Mother, in First-time Mothers

University Rovira i Virgili1 site in 1 country76 target enrollmentNovember 2, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mothers
Sponsor
University Rovira i Virgili
Enrollment
76
Locations
1
Primary Endpoint
Scale name unabbreviated: "La escala de Adopción del Rol Materno (ARM) de la Doctora María del Carmen Garrido Hidalgo y la Doctora Marleny Marchán Coronado".
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 2, 2018
End Date
February 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University Rovira i Virgili
Responsible Party
Principal Investigator
Principal Investigator

Carolina Vargas Porras

Nursing, PhD student in Nursing and Health, Associate Professor

University Rovira i Virgili

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Scale name unabbreviated: "La escala de Adopción del Rol Materno (ARM) de la Doctora María del Carmen Garrido Hidalgo y la Doctora Marleny Marchán Coronado".

Time Frame: 4 Months

Construct: This scale measures the process of maternal role adoption or "becoming mother" process; such process and this scale was created based in Ramona Mercer's theory. Conformation: It consists of 56 items distributed in 10 dimensions: 1)Interaction with the couple with respect to the baby, 2)baby acceptance, 3 Contact with the role of mother, 4)Stimulation of the baby, 5)Interaction with the family of origin regarding to the baby, 6 Baby care, 7)Maternal expressions of affection for the baby, 8)Well-being of the baby, 9)Concern and protection of the baby, 10)Knowledge and culture related to the baby. Scale Scores and Ranges: The instrument has a Likert scale (from 1 to 4). 1 = totally disagree and 4 = total agreement. The score are from 56 to 224. The classification score ranges are: low 56-180 points, medium 181-202 and high 203-224 points. The higher score across the scale indicate better adoption of the maternal role. The outcome of this scale is the sum of each linker-item.

"Bond between parents and children of MSc Alix Nathalya Vargas Vásquez and Doctor Myriam Patricia Pardo Torres"

Time Frame: 4 months

_measures the affective bond between parents and children. This instrument was created by two nurses from the National University of Colombia, Colombia. It has validity and reliability tests in Colombia and Ecuador. Conformation_ Consists of 24 items distributed in 4 dimensions_ 1. Emotional support, 2. Union - interaction, 3. Informative support, 4. Stress. Score and ranges_ the instrument has a Likert scale that goes from 0 to 5. The instrument has a minimum score_ 24 and maximum score_ 96. The low degree of affective bonding is 85 points or less

"Perinatal Infant Care Social Support Scale" (PICSS) by Dr. Patricia Leahy-Warren: Construct: measures social support and has been widely applied in first-time mothers.

Time Frame: 4 months

Conformation: This instrument was created by a nurse from the University of College Cork, Ireland. It has validity and reliability tests in Ireland. Consisting of two subscales, the Structural Social Support subscale measures structural social support and the Functional Social Support subscale that measures functional social support. The latter is the one that is consistent with Ramona Mercer's nursing theory. The subscale Functional Social Support consists of 16 items distributed in 4 dimensions: 1) Informative Support, 2) Instrumental Support (Physical), 3) Emotional Support, 4)Valuation Support. Dimensions: Informative support (Minimum score of 7, maximum score of 28). Instrumental support (score range 7-28). Emotional support (score range 4- 16). Valuation support (score range from 4-16). The instrument has a Likert scale from 1 to 4; 1 for totally disagree and 4 for total agreement. Score range: 22-88. As higher the score, greater (better) Structural Social Support.

Perceived Maternal Parenting Self-Efficacy (PMP S-E) by Dr. Christopher R. Barnes and Dr. Elvidina N. Adamson-Macedo: measures maternal self-efficacy.

Time Frame: 4 months

_this scale measures Perceived Maternal Parenting Self-Efficacy.Conformation: This instrument was created by two psychologists from the University of Wolverhampton, Ireland. It has validity and reliability studies in Ireland and Brazil. It consists of 20 items distributed in 4 dimensions_ 1. Care tasks, 2. Behaviors raised, 3. Reading of behaviors or signals, 4. Situational beliefs. Scale Scores and Ranges_ the instrument has a Likert scale that goes from 1 to 4. There are 1 in totally disagree and 4 in total agreement. The instrument has a minimum score of 20 and a maximum score of 80. The higher the scores indicate greater (better) self-efficacy_

Secondary Outcomes

  • Edinburgh Postnatal Depression Scale (EPDS) of Doctors J.L. Cox; JM Holden and R. Sagovsky (Spanish)(4 months)
  • Assessing the experience of motherhood: The Being a Mother Scale (BaM-13) - Spanish adaptation (by Drs. Lucy Marcela Vesga Gualdrón and Maria Mercedes Durán de Villalobos)(4 months)

Study Sites (1)

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