Clinical trial NCT03594526: Efficacy of a Nursing Intervention in First-time Mothers
Official title: Efficacy of a Nursing Intervention in the Process of Becoming a Mother, in First-time Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mothers
First Birth
Keywords: Nursing Care
Mothers
Research
Support
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: 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".
timeFrame: 4 Months
measure: Perceived Maternal Parenting Self-Efficacy (PMP S-E) by Dr. Christopher R. Barnes and Dr. Elvidina N. Adamson-Macedo: measures maternal self-efficacy.
timeFrame: 4 months
measure: "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.
timeFrame: 4 months
measure: "Bond between parents and children of MSc Alix Nathalya Vargas Vásquez and Doctor Myriam Patricia Pardo Torres"
timeFrame: 4 months
Secondary outcomes:
measure: 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)
timeFrame: 4 months
measure: Edinburgh Postnatal Depression Scale (EPDS) of Doctors J.L. Cox; JM Holden and R. Sagovsky (Spanish)
timeFrame: 4 months
Other outcomes:
Locations:
city: Bucaramanga
country: Colombia
facility: Clinica Materno Infantil San Luis
state: Santander
Study officials:
References:
citation: Nakamura Y, Takeishi Y, Ito N, Ito M, Atogami F, Yoshizawa T. Comfort with motherhood in late pregnancy facilitates maternal role attainment in early postpartum. Tohoku J Exp Med. 2015 Jan;235(1):53-9. doi: 10.1620/tjem.235.53.
citation: Maehara K, Mori E, Tsuchiya M, Iwata H, Sakajo A, Ozawa H, Morita A, Maekawa T, Makaya M, Tamakoshi K. Factors affecting maternal confidence among older and younger Japanese primiparae at one month post-partum. Jpn J Nurs Sci. 2016 Oct;13(4):424-436. doi: 10.1111/jjns.12123. Epub 2016 May 11.
citation: Gao LL, Xie W, Yang X, Chan SW. Effects of an interpersonal-psychotherapy-oriented postnatal programme for Chinese first-time mothers: a randomized controlled trial. Int J Nurs Stud. 2015 Jan;52(1):22-9. doi: 10.1016/j.ijnurstu.2014.06.006. Epub 2014 Jun 19.
citation: Shorey S, Chan WC, Chong YS, He HG. A randomized controlled trial of the effectiveness of a postnatal psychoeducation programme on outcomes of primiparas: study protocol. J Adv Nurs. 2015 Jan;71(1):193-203. doi: 10.1111/jan.12461. Epub 2014 Jun 9.
citation: Shorey S, Chan SW, Chong YS, He HG. Perceptions of primiparas on a postnatal psychoeducation programme: the process evaluation. Midwifery. 2015 Jan;31(1):155-63. doi: 10.1016/j.midw.2014.08.001. Epub 2014 Aug 13.
citation: Vargas-Porras C, Roa-Diaz ZM, Hernandez-Hincapie HG, Ferre-Grau C, de Molina-Fernandez MI. Efficacy of a multimodal nursing intervention strategy in the process of becoming a mother: A randomized controlled trial. Res Nurs Health. 2021 Jun;44(3):424-437. doi: 10.1002/nur.22123. Epub 2021 Mar 8.