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NeuroMusic: protocol for a randomised-controlled trial of keyboard and singing music training programmes for older adults with mild cognitive impairment

Por: Menczel Schrire · Z. · Mitchell · H. F. · Low · L.-F. · Espinosa · N. · Eames · P. · Toltz · J. · Walsh · P. · Mowszowski · L. · Espinoza · D. · Lin · C. S.-Y. · Peres Da Costa · N. · Naismith · S. L.
Introduction

Music-based training programmes, such as learning how to play an instrument or sing in a choir, have been suggested as potential interventions for promoting healthy brain ageing in older adults at risk of cognitive decline because of their ability to enhance cognitive functions and potentially promote neuroplasticity. However, there is limited empirical evidence in older adults at risk of dementia, especially that evaluates both piano and singing interventions and their effects on cognition and neuroplasticity. In this protocol, we outline a study to assess the efficacy of keyboard and singing music training programmes on reducing cognitive decline and other outcomes in older adults with Mild Cognitive Impairment (MCI).

Methods and analysis

This randomised, single-blind, controlled, parallel-group trial aims to enrol 432 individuals with MCI from the community in Sydney, Australia. Participants are randomly allocated to participate in either keyboard lessons, singing lessons or a film discussion control group once a week for 3 months. The primary objective is to assess the effectiveness of two music training programmes (keyboard and choral singing) for enhancing verbal memory after 3 months compared with control. Additionally, we will examine how these music-based interventions affect other aspects of cognition, mood, sleep, overall well-being, markers of brain plasticity and blood biomarkers of Alzheimer’s disease and neurodegeneration. Tertiary objectives are to identify factors that impact the success of the interventions, such as participation rates, engagement levels and key demographic and clinical features. Outcomes are collected at baseline and at 3 and 9 months. The primary endpoint analysis will include all randomised participants to estimate the treatment effect using intention-to-treat principles. Primary and secondary outcomes will be analysed using linear mixed models and effect size measures will be calculated.

This study will be the first robust, randomised controlled trial to assess the potential and relative value of music engagement for cognitive decline in high-risk MCI individuals, as well as broader effects on other markers of mental health, well-being and neurodegeneration. Co-designed with implementation in mind, the music interventions can potentially be delivered within memory clinic or community settings.

Ethics and dissemination

The Sydney University Human Research Ethics Committee (2023-026) has approved this protocol. The trial findings will be shared through conferences, publications and media.

Trial registration number

Australian and New Zealand Clinical Trials Registry (ACTRN12623000407695), Registered 21/04/2023 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385552

Protocol version

2.02 29/11/2024.

Feasibility study of the internet-based intervention 'Strategies for Empowering activities in Everyday life (SEE 2.0) for use by people with chronic diseases and long-term disorders in healthcare: a study protocol

Por: Larsson-Lund · M. · Karlsson Sundbaum · J. · Mansson Lexell · E. · Spinord · L.
Introduction

Proactive and easily accessible interventions are needed to support people with long-term health conditions who experience limitations in activities of everyday life. However, there is a lack of interventions that promote self-management skills that prevent deterioration and improve health. The internet-based programme ‘Strategies for Empowering Activities in Everyday Life’ (SEE) supports people with long-term health conditions in developing self-management skills through knowledge, self-analysis and management strategies, promoting active and healthy daily life. This study protocol aims to evaluate the feasibility of SEE 2.0 and the study design.

Methods and analysis

This feasibility study employs a pretest and post-test design with no control group, embedded within a mixed-method approach. The participants will include 30–40 clients, occupational therapists and managers involved in delivering SEE 2.0 in primary healthcare and hospital-based services. Data will be collected through assessments and forms at baseline, 4 months and 12 months after inclusion. Additionally, qualitative methods will be used to enhance the understanding of participants’ experiences.

Ethics and dissemination

The study was approved by the Swedish Ethical Review Authority. The results will inform the refinement of SEE 2.0 and guide decisions on whether to proceed with planning a full-scale evaluation to assess the intervention’s effect. The results will be published in peer-reviewed scientific journals on websites and presented at conferences and seminars to reach various user groups.

Trial registration number

NCT06484322.

Cultivating Compassion in Students for End‐Of‐Life Processes: A Mixed‐Methods Participatory Research Protocol

ABSTRACT

Aims

To analyse the impact of a participatory process of awareness and reflection on compassion, in the face of end-of-life processes, in students aged 12–23 years in six Spanish regions, and to understand how the participatory process can transform their compassion.

Design

Mixed sequential transformative methodology with different phases. In the first phase, a prospective quasi-experimental design with evaluation pre-post in a single group will be adopted. The second phase is the intervention under study, which will consist of a Participatory Action Research with concurrent evaluations.

Methods

In the quantitative phase, 1390 students aged 12–23 from a Public University and a Public Secondary Education Institute across six different Spanish regions will be included. A single questionnaire will be administered before and after the Participatory Action Research to contribute to the process evaluation, incorporating four scales (compassion for others' lives, Death Anxiety Scale, basic empathy modified for adolescents and self-compassion). Responses will be recorded in the Research Electronic Data Capture system. For data analysis, comparison groups, change evolution and associations between variables will be examined, along with multivariate logistic regression models. In the qualitative phase of participatory action research, a promoter group will be established in each university and secondary school in every region. Qualitative data will be analysed following the authenticity, transferability, auditability and neutrality criteria. Discourse analysis triangulation will be conducted to achieve data saturation.

Conclusions

Implementing participative action research in the educational environment to improve students' compassion makes them capable of founding compassion communities to help those who have a terminal illness.

Reporting Method

This study will adhere to the relevant EQUATOR guidelines, such as the Good Reporting of a Mixed Methods Study guideline, to efficiently report its results through the different steps of this mixed-methods study.

Patient or Public Contribution

Participatory action research is a method that enables participants to act as researchers of the phenomenon under study, facilitating the immediate application of results within the context. Although students did not participate in the writing of the proposal grant or the research design.

Trial and Registration

This study registered on Clinical Trials (NCT06310434), was initiated in January 2024, and it will continue up to December 2026.

Nursing Implications

This multicentre study will contribute to the nursing community with an overview of compassion for those at the end of their lives among young people and provide the knowledge needed to cultivate compassion at universities and schools.

Impact

Implementing compassion programmes and death education in the educational environment will empower students to create a compassionate community. The double evaluation of the process will contribute to the qualitative databases.

The leishmaniases in Kenya: a scoping review sub-analysis of diagnostics

Por: OBrien · K. · Grifferty · G. · Shirley · H. · George · S. · Binkley · A. · Orriols · A. M. · Espinola Coombs · P. · Williams · A. L. · Wong · M. G. · Roe · S. · Wallace · F. · Tschoepe · K. · Hirsch · J. L. · Wamai · R.
Objectives

Leishmaniasis poses a significant public health problem in Kenya, where effective case management and treatment rely on accurate diagnosis. This review aims to summarise the research landscape on leishmaniasis diagnostics in Kenya and identify gaps.

Design

This scoping review expands a previously published scoping review on leishmaniasis in Kenya to further analyse studies focusing on diagnostics. The field of diagnostics was chosen because of recent pushes for novel tools and because of the role timely diagnosis plays in disease elimination. A comprehensive search of PubMed, Embase via Embase.com, Web of Science Core Collection, the Cochrane Library, ClinicalTrials.gov, WHO ICTRP and the Pan African Clinical Trials Registry was conducted, covering studies up to 5 January 2024.

Results

After dual, blind screening with conflict resolution by a third reviewer, 41 studies were included in the review. These studies examined a range of diagnostic tools; however most were assessed in one or few studies, and none evaluated real-time PCR. Additional gaps in the research landscape include a lack of diagnostics for cutaneous leishmaniasis and post-kala-azar dermal leishmaniasis in Kenya, outdated literature surrounding the Direct Agglutination Test and randomised trials for any diagnostic tool.

Conclusions

Future research should focus on solidifying the validity and reliability of diagnostic tools in the Kenyan context and updating previous work.

Leishmaniases in Kenya: a scoping review subanalysis of vectors

Por: OBrien · K. · Grifferty · G. · Shirley · H. · Wanjiku · C. · Binkley · A. · Williams · A. L. · Espinola Coombs · P. · Wong · M. G. · Roe · S. · Wallace · F. · Tschoepe · K. · Orriols · A. M. · Hirsch · J. L. · Wamai · R.
Objectives

Vector control is imperative for eliminating leishmaniasis as a public health problem in Kenya. As elimination efforts expand in East Africa, it is crucial to understand the current research landscape. To address that need and identify gaps, a scoping review was conducted to characterise the landscape of leishmaniasis vector research in Kenya.

Design

Building on a previously published scoping review by this team, we updated database searches in PubMed, Embase via Embase.com, Web of Science Core Collection, the Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) and the Pan African Clinical Trials Registry to incorporate literature up to 4 January 2024 and focused on vector-related papers. Studies classified as ‘prevention’ in the original scoping review were included due to overlapping definitions.

Results

A total of 95 studies were included in the analysis. Although a wide range of sandfly species have been documented, most of the research is outdated, having taken place 20–40 years ago. Existing studies are mostly epidemiological with little focus on basic and clinical research. There are also no studies on post-kala-azar dermal leishmaniasis despite its potential contribution to the disease transmission cycle. The geographical scope of the research is largely limited to traditional transmission foci with little attention to new disease hotspots such as North Eastern Kenya.

Conclusions

These research gaps need to be addressed to better inform the country’s leishmaniasis prevention and vector control strategy.

Continuous or discrete magnitudes? A comparative study between cats, dogs and humans

by Mireia Solé Pi, Luz A. Espino, Péter Szenczi, Marcos Rosetti, Oxána Bánszegi

A long-standing question in the study of quantity discrimination is what stimulus properties are controlling choice. While some species have been found to do it based on the total amount of stimuli and without using numerical information, others prefer numeric rather than any continuous magnitude. Here, we tested cats, dogs, and humans using a simple two-way spontaneous choice paradigm (involving food for the first two, images for the latter) to see whether numerosity or total surface area has a greater influence on their decision. We found that cats showed preference for the larger amount of food when the ratio between the stimuli was 0.5, but not when it was 0.67; dogs did not differentiate between stimuli presenting the two options (smaller vs. larger amount of food) regardless of the ratio between them, but humans did so almost perfectly. When faced with two stimuli of the same area but different shapes, dogs and humans exhibited a preference for certain shapes, particularly the circle, while cats’ choices seemed to be at chance level. Furthermore, cats’ and dogs’ reaction times were equal across conditions, while humans were quicker when choosing between stimuli in trials where the shape was the same, but the surface area was different, and even more so when asked to choose between two differently sized circle shapes. Results suggest that there is no universal rule regarding how to process quantity, but rather that quantity estimation seems to be tied to the ecological context of each species. Future work should focus on testing quantity estimation in different contexts and different sources of motivation.

Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anaesthesia (THRIVE) randomised controlled trial in the USA: A protocol

Por: Tellor Pennington · B. R. · Janda · A. M. · Colquhoun · D. A. · Neuman · M. D. · Kidwell · K. M. · Spino · C. · Thelen-Perry · S. · Krambrink · A. · Huang · S. · Ignacio · R. · Wu · Z. · Swisher · L. · Cloyd · C. · Vaughn · M. T. · Pescatore · N. A. · Bollini · M. L. · Mashour · G. A.
Introduction

Millions of patients receive general anaesthesia every year with either propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA). It is currently unknown which of these techniques is superior in relation to patient experience, safety and clinical outcomes. The primary aims of this trial are to determine (1) whether patients undergoing (a) major inpatient surgery, (b) minor inpatient surgery or (c) outpatient surgery have a superior quality of recovery after INVA or TIVA and (2) whether TIVA confers no more than a small (0.2%) increased risk of definite intraoperative awareness than INVA.

Methods and analysis

This protocol was co-created by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 13 000-patient, multicentre, patient-blinded, randomised, comparative effectiveness trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to one of two anaesthetic approaches, TIVA or INVA, using minimisation. The primary effectiveness endpoints are Quality of Recovery-15 (QOR-15) score on postoperative day (POD) 1 in patients undergoing (1) major inpatient surgery, (2) minor inpatient surgery or (3) outpatient surgery, and the primary safety endpoint is the incidence of unintended definite intraoperative awareness with recall in all patients, assessed on POD1 or POD30. Secondary endpoints include QOR-15 score on POD0, POD2 and POD7; incidence of delirium on POD0 and POD1; functional status on POD30 and POD90; health-related quality of life on POD30, POD90, POD180 and POD365; days alive and at home at POD30; patient satisfaction with anaesthesia at POD2; respiratory failure on POD0; kidney injury on POD7; all-cause mortality at POD30 and POD90; intraoperative hypotension; moderate-to-severe intraoperative movement; unplanned hospital admission after outpatient surgery in a free-standing ambulatory surgery centre setting; propofol-related infusion syndrome and malignant hyperthermia.

Ethics and dissemination

This study is approved by the ethics board at Washington University, serving as the single Institutional Review Board for all participating sites. Recruitment began in September 2023. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.

Trial registration number

NCT05991453.

Determinants of enrolment rate in 397 clinical trials for healing diabetic foot ulcers: a systematic review

Por: Zhang · L. · Purkayastha · S. · Lev-Tov · H. · Nie · R. · Kirsner · R. · Spino · C. · Song · P. X. K.
Objectives

Diabetes mellitus (DM) affects over 422 million individuals globally. Diabetic foot ulcers (DFUs) stand out as a challenging complication of DM, affecting up to 34% of individuals with DM. Despite the prevalence of DFUs, clinical trials for DFUs often face slow and insufficient patient recruitment. We aimed to identify key determinants that impact subject recruitment rates in DFU clinical trials.

Design

Systematic review.

Data sources

ClinicalTrials.gov and PubMed were searched to identify DFU clinical studies published from 1 January 1990 to 9 April 2025.

Eligibility criteria

We included English-language publications of clinical trials aimed at healing DFUs that reported enrolment numbers, duration of enrolment and number of study centres.

Data extraction and synthesis

Records were extracted and subjected to two independent rounds of review by five authors (LZ, SP, RN, HL-T, and RK). Data were pooled and analysed using negative binomial regression, Kaplan-Meier methods and Cox proportional hazards models. Study enrolment and site enrolment rates, as well as time to complete study enrolment, were analysed. Between-study heterogeneity was assessed using the likelihood ratio test.

Results

397 trials involving 31 955 participants were included. On average, DFU studies enrolled 4.24 patients per month (median: 1.65). US-based studies had slower recruitment than non-US studies, with a mean enrolment rate of 1.51 patients per site per month (median: 0.58). The average time to complete enrolment was 1.28 years. Studies that employed a higher number of study sites, were conducted outside the USA, studied behavioural or dietary supplement interventions, and began enrolment more recently, were more likely to have a higher enrolment rate. Longer time to complete enrolment was associated with a larger number of study sites, trials involving at least one US site, earlier starting enrolment year, and longer follow-up duration.

Conclusions

These findings have potential practical implications for the design and conduct of future DFU trials.

Cuidado a mujeres indígenas en trabajo de parto como fortaleza de la humanización de Enfermería

Introducción: En la atención del parto es primordial brindar cuidado humanizado a la madre, garantizando de esta forma el respeto a su dignidad, bienestar y cultura. Objetivo: Describir la atención y cuidados que brinda el personal de enfermería durante el parto a mujeres hablantes de lengua náhuatl y comparla con la percepción de las y los enfermeros. Materiales y método: Investigación cualitativa, con ocho mujeres hablantes de la lengua náhuatl de Uxtuapan, a quienes se les realizó una entrevista semiestructurada mediante grupo focal y una segunda entrevista individualizada en domicilio. También se entrevistaron a 11 profesionales de enfermería con grabadora de voz. Se transcribieron las entrevistas, se identificaron unidades de significado, se recategorizó y se describieron los resultados a través de la conformación de categorías: Cuidado, Entorno, Cultura, Relación ayuda-confianza. Se respetó la confidencialidad de los datos. Resultados: La falta de comunicación, tiempo e interacción en la relación enfermera-paciente favorece una percepción errónea de las pacientes ante su cuidado, denotando maltrato, soledad, falta de empatía. Conclusión: Para asegurar el cuidado humanizado en la atención del parto, se requiere mantener una conexión con las mujeres y cuidadores, donde se respeta su cultura y se favorece la seguridad de la vida humana.

Violencia en pareja en personas seropositivas: una revisión sistemática

El presente trabajo tiene como objetivo, caracterizar la violencia en pareja en personas con seropositividad (prevalencia, tipos de acciones violentas, variables de riesgo/ protectoras y consecuencias), para lo cual se realizó una revisión sistemática a través del protocolo PRISMA. La búsqueda de artículos se realizó en Scopus, Web of Science, Eric, Scielo y Pubmed publicados hasta 2021. Se encontraron 113 artículos, de los cuales 22 cumplieron con los criterios de elegibilidad. Los resultados indican que la violencia en pareja en personas seropositivas, además de manifestarse de manera física, psicológica, patrimonial, sexual y verbal, se puede presentar a través del uso del VIH para ejercer la violencia. La prevalencia varía en función del contexto geográfico en un intervalo del 19,6% al 43,1%; la cual es superior en población migrante y en hombres que tienen sexo con hombres (HSH) mujeres seropositivas, parejas no heterosexuales y en parejas en la que ambos miembros son seropositivos. Las variables de riesgo/ protectoras identificadas se asociaron con las dimensiones: informativas, motivacionales, de habilidades conductuales, sociodemográficas, culturales, de salud, sociofamiliares y políticas. Asimismo, se evidenciaron consecuencias sociales, económicas y de salud.

Subestructuración teórica: Miedo, ansiedad y estrés postraumático durante la transición del cuidado a pacientes Covid-19

Objetivo: Generar una teoría de situación específica para explicar el control de miedo, ansiedad y estrés postraumático en personal de enfermería que atendió a pacientes Covid. Desarrollo: La teoría de las transiciones, fue base para la teoría de situación específica con los cuatro pasos de Dulock y Holzemer: (1) identificar y aislar principales conceptos, (2) especificar relaciones entre conceptos, (3) ordenar jerárquicamente los conceptos según nivel de abstracción, y (4) ilustrar relaciones actuales entre variables. Conclusión principal: La teoría de situación específica para explicar el control de miedo, ansiedad y estrés postraumático basada en la Teoría de las Transiciones es útil para explicar las condiciones de transición personales que facilitan e inhiben el paso hacia un nuevo rol de cuidado y explicar indicadores que intervienen en el proceso y resultado en el personal de enfermería.

Hipotermia terapéutica como efecto neuroprotector y reductor de la mortalidad neonatal: una revisión sistemática

Objetivo principal: Determinar la efectividad de la hipotermia terapéutica (HT) como medida de neuroprotección y de reducción de la mortalidad en recién nacidos con encefalopatía hipóxico-isquémica (EHI). Metodología: Enfermería Basada en Evidencia. Bases de datos consultadas: Cinahl, Cuiden, Epistemonikos, Lilacs, PubMed, Scopus, Scient Direct, Scielo, Librería Cochrane y Google Académico, traducción documental a través del DeCS, lectura crítica realizada mediante FLC 3.0 y síntesis de la evidencia de acuerdo con la escala Oxford. Resultados principales: 18 estudios comparados, encontrándose un 83% de efectividad neuroprotectora de la HT, evidenciando la importancia de su aplicación en tiempos <6 y 6-12 horas. Conclusiones principales: La HT tiene un impacto positivo en el tratamiento de la EHI de moderada a grave, mejora la neuroprotección, aumenta la función neurológica y el pronóstico del sistema nervioso, disminuye la discapacidad grave y la tasa de morbimortalidad neonatal.

Deceso infantil asociado al cáncer: proceso de duelo en profesionales de enfermería

El cáncer es un grupo de enfermedades que tienen en común la presencia de células malignas y el crecimiento invasivo de estas, situación que se presenta, en el caso del cáncer infantil, entre el nacimiento y los 15 años de edad. En Chile, según datos entregados por el Registro Nacional de Cáncer Infantil de Chile, al año se diagnostican entre 490 y 500 niños y adolescentes con esta enfermedad, de los cuales actualmente el 78% sobrevive, cifra que podría aumentar o disminuir dependiendo del tipo de cáncer y el riesgo de éste [Fragmento de texto].

Aplicación de elementos teóricos y metodológicos del cuidado de enfermería

Objetivo: identificar los elementos teóricos y metodológicos del cuidado que aplican los profesionales de enfermería en dos instituciones de salud del Departamento del Atlántico. Metodología: estudio descriptivo, transversal, la muestra estuvo conformada por 60 enfermeras de dos instituciones de salud. La obtención de datos se realizó a través de un cuestionario, consignándose las variables significativas, el análisis de los datos se calcularon en frecuencias absolutas y porcentajes. Resultados: predominó el grupo etario de 23 a 27 años: 43%, el género femenino: 100%, el 76% señalaron dificultades en la aplicación; Modelos de Enfermería orientadores de la práctica: Dorotea Orem: 78%; en la Aplicación de teorías Florence Nightingale: 73%, entre otros. Conclusión: Las enfermeras señalan que sí recibieron en el pregrado conocimientos sobre el tema, pero en la práctica algunas no los aplican; situación preocupante, debida a que no se reconoce la importancia de los principios científicos y filosóficos que orientan la profesión.

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