Open Access
The CRIAA Program complex intervention in primary care to support women and their families in breastfeeding: study protocol for a pilot trial
(Wiley, 2020) Lucchini-Raies, Camila; Márquez-Doren, Francisca; Beca, Paulina; Pérez, J. Carola; Campos, Solange; López de Dicastillo Sáinz de Murieta, Olga; Ciencias de la Salud; Osasun Zientziak
Aim: To report a pilot study protocol to assess the feasibility of a complex intervention, in the primary healthcare context, to support women and their families in breastfeeding. Design: A pilot/feasibility trial with control and intervention groups. Methods: The study will be conducted in two primary healthcare centres with 40 childbearing women (20 control group; 20 intervention group), with their partner/meaningful person and their respective healthcare professionals. Intervention group participants will receive the intervention: (a) in a breastfeeding workshop during their third trimester of pregnancy; and (b) via virtual breastfeeding support for six months postpartum. Health professionals will be trained to deliver the intervention. The control group will receive standard care in the outpatient clinic. The pilot will help determine the intervention's feasibility. Data collected pre-intervention, 10-days postpartum and two-, four-, and six-months postpartum will provide estimates of the intervention's preliminary effects on self-efficacy and main outcomes. Research Ethics Committee approval was obtained in April 2019. Discussion: Breastfeeding support is a complex reality influenced by multiple factors. Therefore, approaches to breastfeeding are also, requiring interventions that address its multidimensional nature, including all actors involved. The proposed intervention will be applied by an interdisciplinary professional health team, allowing for its incorporation into standard practice and its perpetual maintenance. Impact: The study will produce an original, comprehensive, complex intervention addressing contextual, and organizational factors to promote breastfeeding support using an interdisciplinary and family-based approach; breastfeeding self-efficacy is the core concept. The program evaluation and feasibility study will permit exploration of the integration of the intervention's novel aspects into the daily work of professionals and reveal how to better use existing resources in a full-scale clinical trial. Trial registration: ClinicalTrials.gov ID: NCT03944642.
Open Access
A complex intervention to support breastfeeding: a feasibility and acceptability study
(Wiley, 2023-07-18) Lucchini-Raies, Camila; Márquez-Doren, Francisca; Pérez, J. Carola; Campos, Solange; Beca, Paulina; López de Dicastillo Sáinz de Murieta, Olga; Ciencias de la Salud; Osasun Zientziak
Aims: The aims of this study are to assess the acceptability and feasibility of a multicomponent intervention to support breastfeeding women and their families and explore its effectiveness. Methods: A pilot study with control and intervention groups was conducted using the complex intervention framework in two primary healthcare centres. Overall, 44 childbearing women, their partners/relatives and 20 healthcare professionals participated in the study. The intervention's feasibility and acceptability were measured. The percentage of exclusive breastfeeding rates and women's self-efficacy were measured at pre-intervention, at 10 days postpartum, and again at 2, 4 and 6 months postpartum. Postpartum depression risk was measured at 2 and 6 months postpartum. Professional self-efficacy was measured at pre-intervention and 3 months later. Results: The intervention was feasible and acceptable. No difference in self-efficacy existed between the intervention and control groups. Preliminary effects of the intervention were found in exclusive breastfeeding percentage and postpartum depression risk in the intervention group. Conclusion: The intervention is feasible and acceptable. The results are promising not only for breastfeeding maintenance but also for preventing postpartum depression and recovering exclusive breastfeeding during pandemics.
Open Access
Building capacity for health promotion by addressing nurses' role confusion: study protocol of a pilot clustered randomised controlled trial
(Wiley, 2021) Iriarte Roteta, Andrea; López de Dicastillo Sáinz de Murieta, Olga; Mujika Zabaleta, Agurtzane; Antoñanzas Baztán, Elena; Hernantes Colias, Naia; Galán Espinilla, María José; Pumar Méndez, María Jesús; Ciencias de la Salud; Osasun Zientziak; Gobierno de Navarra / Nafarroako Gobernua
Aim: To describe the protocol for the pilot phase of a complex intervention, designed to address primary care nurses' role confusion in health promotion. Design: A pilot clustered randomized controlled trial, with control and intervention groups. Methods: The study will be conducted in a primary care setting. Participants will be nurses from the primary care health service working in a primary care team (PCT, 15 control group; 15 intervention group). Nurses in the experimental group will receive the ROLE-AP programme over a 3-week period. The control group will continue with the normal routine. The pilot will help determine the intervention's feasibility, acceptability, fidelity and quality of the programme components. Data collected preintervention, postintervention and 3 months after intervention will provide estimates of the intervention's preliminary effects on the main variable, nurses' degree of agreement concerning their expected role in health promotion. The study received funding from the local government in December 2019. Discussion: Role confusion is promoting primary care nurses' omissions in their health-promoting practice, which is far from the ideal portrayed by the Ottawa Charter. Interventions are needed that reveal the most appropriate mechanisms for addressing role confusion, which requires reaching an intraprofessional agreement about the expectations for role activities. Healthcare organisations could benefit from the incorporation of a programme of these characteristics into standard practice. Impact: This study will produce a novel and comprehensive complex intervention that is expected to build nurses' capacity in primary healthcare organizations for health promotion, which is key to increasing the quality, efficiency and sustainability of the National Health System. The programme evaluation and feasibility study will reveal how to better use existing resources in a full-scale clinical trial.

López de Dicastillo Sáinz de Murieta, Olga

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