Postictal agitation (PIA) is a common adverse effect following electroconvulsive therapy (ECT). Current pharmacological treatments for PIA have undesirable side effects, and interventions to prevent PIA are unsatisfactory. The aim of this study is to assess the effect of peri-interventional music on PIA for patients undergoing ECT. Additionally, the study will assess the impact of music on pretreatment anxiety and post-treatment cognitive impairment.

This multicentre, open-label, parallel randomised controlled trial (RCT) aims to include 92 patients from two centres in Rotterdam, the Netherlands. Participants will be randomised into two groups: a music intervention group and a control group. The music group listens to recorded music 30 min before and 12 min after each of the first six ECT sessions of the full ECT course, while the control group will receive standard care. The primary outcome is the presence of PIA, measured using the Richmond Agitation-Sedation Scale (RASS). Secondary outcomes include the severity and duration of PIA, pretreatment anxiety, recovery duration, peri-treatment medication requirements, cognitive impairment and depression severity. Data will be analysed according to an intention-to-treat principle.

This study protocol has been approved by the Medical Ethical Review Committee of the Erasmus Medical Centre on 28 January 2025 (MEC-2024–0467) and subsequently received local approval at Antes Parnassia group. The trial will be carried out following the Declaration of Helsinki principles. Study results will be reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.

NCT06817330.

The EPHOR-NIGHT cohort was established to investigate how night shift work influences biological pathways and chronic disease risk using a comprehensive working-life exposome approach, focusing on cardiometabolic, mental health, cognitive and biological ageing outcomes.

The cohort includes 937 workers aged 20–65 years (88% female), primarily from the healthcare sector (96%) in Spain, Sweden, Denmark and the Netherlands. Participants were categorised as permanent day (39%), permanent night (35%) or rotating/other shift workers (26%). Data collection included questionnaires, daily ecological momentary assessments, wearable sensors tracking light, physical activity, heart rate and environmental exposures and biological samples (blood collected once and saliva collected during five points across the day), with harmonised protocols across countries.

From the 937 participants contributing data to the cohort, 708 had complete information from questionnaires, sensors and blood and saliva, with subsets undergoing advanced biological analyses, including genomics, targeted and genome-wide DNA methylation, telomere length and mtDNA copy number, metabolomics, transcriptomics, proteomics, hormone profiling and inflammatory biomarkers and blood metals. Many reported prevalent chronic conditions, including anxiety (27%), depression (18%) and metabolic disturbances. Night shift and rotating shift workers had greater exposure to long shifts and more scheduled rest days compared with day workers. Sleep duration and quality were poorest among permanent night shift workers.

A 2-year follow-up was completed in June 2025, including the collection of additional biomarker data, psychosocial work environment data and data related to female sexual and reproductive health. Findings from the EPHOR-NIGHT study aim to inform prevention strategies and occupational health policies. Data will be made available to support broader research efforts on shift work and health.

To investigate the attitudes of physicians towards addressing environmental sustainability in patient conversations, and to identify barriers and facilitators to doing so.

A qualitative, nation-wide study was conducted using semi-structured online focus groups and interviews. Reflexive thematic analysis was used to analyse transcripts, guided by the Theoretical Domains Framework.

Secondary and tertiary healthcare institutions in the Netherlands.

Participants were medical specialists and residents in obstetrics and gynaecology (OB-GYN physicians) in the Netherlands. Participants were purposefully identified to capture diverse demographics and practice settings.

Physicians’ attitudes towards discussing the environmental impact of healthcare and the health effects of environmental pollution with patients. Themes were identified and categorised using the Theoretical Domains Framework.

The study included 28 OB-GYN physicians working across 23 healthcare institutions in the Netherlands. Six themes were developed: (1) strong sense of urgency to reduce healthcare's environmental impact, (2) knowledge gaps impair communication about environmental impact to patients, (3) prioritisation of individual patient health over environmental concerns in decision-making, (4) perceived lack of patient interest in environmental outcomes, (5) system-level support facilitates discussions about environmental sustainability with patients and (6) limited perceived value in discussing the health effects of environmental pollution and climate change with patients.

OB-GYN physicians are supportive of discussing the environmental impact of healthcare services when clinically appropriate. Addressing knowledge gaps, providing evidence-based guidance and embedding sustainability into clinical guidelines and decision aids may facilitate the integration of environmental sustainability into patient-provider interactions.

Military personnel are a unique population with heightened vulnerability to sexually transmitted infections (STIs), often exhibiting higher prevalence rates than civilians due to demographic, environmental and occupational factors. These vulnerabilities underscore the need for global prevalence estimates to guide effective, evidence-based interventions. This study aims to quantify the global burden of STIs among military personnel, providing a comprehensive and up-to-date assessment.

This systematic review will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Guidelines (2020). Using the CoCoPop (Condition, Context, and Population) framework, a comprehensive search strategy will be conducted in MEDLINE, Embase, Global Health and Scopus to retrieve peer-reviewed records published between January 2010 and June 2025. Eligible studies will report numerical STI prevalence data among military personnel. Studies with insufficient information to calculate prevalence or those relying on self-reported STI data will be excluded. Data extraction will include study details, military descriptors, STI prevalence and diagnostic methods. Risk of bias will be assessed using the Joanna Briggs Institute critical assessment tool for prevalence and incidence studies. Prevalence estimates with 95% CIs will be reported for each STI and, where appropriate, pooled for curable STIs. Subgroup analyses will stratify prevalence by geographic region, service status, deployment status and socioeconomic factors. Heterogeneity will be evaluated within predefined subgroups using the I² statistic. Data will be presented in comprehensive tables and visualised with graphical tools, including forest plots for subgroup analyses and pooled estimates.

Ethical approval is not required for this review. The results will be disseminated through a peer-reviewed publication and conference presentations.

CRD42023472113.

Saskatchewan is facing a public health crisis driven by high rates of HIV, syphilis and hepatitis C virus (HCV) infections, particularly among people who use drugs. Injection drug use is a major contributor to these syndemic infections, exacerbated by structural barriers such as stigma, poverty and limited culturally safe healthcare. Innovative, community-informed approaches are urgently needed to improve prevention, testing and linkage to care.

This study will implement a rapid assessment and response system in Regina, Saskatchewan, Canada, integrating geospatial mapping of community needle prevalence with pop-up interventions. Needle hotspot maps will be used to guide the deployment of community-based pop-up events offering point-of-care testing for HIV, syphilis and HCV, alongside education on pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP). A convergent participatory mixed-methods design will be used to evaluate feasibility, acceptability and effectiveness, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Quantitative data will assess changes in knowledge of PrEP and PEP, satisfaction with the intervention and report new diagnoses and participant demographics descriptively. A qualitative substudy will include 30 participants and will explore experiences with the intervention, barriers to care and perceptions of service delivery.

Ethical approval has been obtained from the research ethics board of the Saskatchewan Health Authority (#24–91). Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study may provide a model of community-based geospatial testing and education that could be scaled up and adapted elsewhere.

Open Science Framework https://doi.org/10.17605/OSF.IO/HVK3B

Heart failure (HF) is a prevalent cardiovascular disease worldwide, affecting 1–2% of adults. According to the WHO 2022 report, Pakistan ranks 18th globally for HF-related deaths. The exact prevalence of HF is not well documented. Additionally, knowledge and self-care behaviour among patients with HF are suboptimal. Therefore, this study aims to assess the knowledge and self-care behaviours of patients with HF before being discharged from the hospital and tracks the time to 30-day readmissions.

A prospective cohort research design will be used. Patients will be recruited from three tertiary care hospitals through consecutive sampling based on specific inclusion criteria. A structured tool will be used to collect demographic and clinical variables from 227 patients with HF. The Urdu version of the knowledge and self-care behaviour questionnaires will be used to collect the data. Kaplan-Meier product limit method and Cox proportional hazards model will be employed to obtain estimates with 95% CIs.

The study has been approved by the Institutional Review Board (IRB) of Shifa Tameer-e-Millat University, Pakistan (IRB 103-24), and written permission was obtained from the administration of the understudy hospitals. Before obtaining a written consent, all patients will receive detailed information about the study. Patients will have the freedom to withdraw from the study at any point. Patients’ confidentiality will be ensured. The study findings will be disseminated to essential stakeholders and published in scientific papers and conference proceedings.

Diabetic foot ulcers (DFUs) are highly prevalent and recurrent complications of diabetes mellitus that have significant health and cost implications. Self-care is critical for preventing or delaying DFU and promoting healing, yet adherence to self-care recommendations is low. Interventions using motivational interviewing (MI) have been effective in supporting behaviour change and emotional adjustment, but evidence for DFU is scarce. This study will assess the acceptability, feasibility and preliminary efficacy of an MI-guided programme, Healing DFU through Empowerment and Active Listening (HEALing), and its integration in usual wound care practice.

This single-arm pilot study adopts a mixed-methods approach to assess the feasibility and acceptability of the HEALing intervention. HEALing is a practical, low-intensity, clinic-integrated personalised self-care support intervention, comprising three 30 min face-to-face sessions delivered over 6 weeks by trained wound care nurses, aiming to enhance self-care behaviours and support emotional adjustment in patients with DFU. Data will be collected from a battery of questionnaire-based surveys with patients (n=30), and in-depth individual interviews with both patients (n=30) and wound care nurse facilitators (n=10) from nurse-led wound clinics in a large primary care sector in Singapore.

The primary feasibility outcomes will include enrolment, retention (≥80%), data completion (≥80% of surveys) and participant satisfaction. Secondary outcomes will include self-report measures of illness perceptions, foot care confidence, diabetes distress, foot self-care behaviour, DFU knowledge, autonomy support and health-related quality of life, taken at baseline and post-intervention. Post-intervention interviews with patients and wound care nurse facilitators will be conducted to collect feedback on the programme and its implementation feasibility.

The study protocol has been approved by the local ethics committee, and written informed consent will be obtained from all participants. Findings will be disseminated through the first author’s PhD thesis, peer-reviewed journals, national and international conferences and public events.

NCT06540170; Pre-results.

Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.

MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.

This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.

Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.

NCT06953479.

Providing care management, treatment and support to patients with Alzheimer’s Disease and Related Dementias (ADRD) is a difficult task for health systems. Over the past 20 years, interventions designed to improve outcomes for patients living in the community with dementia and their care partners have moved progressively, but separately, from large scale trials and pragmatic models of collaborative care. Given the projected increase in the number of people living with dementia coupled with the realignment of payment for services to be value-based and provided in the community, system-level approaches are needed to address the complex needs of patients with a dementia diagnosis and their care partners. We designed a statewide, pragmatic trial to evaluate virtual delivery of an evidence-based dementia collaborative care program on patient healthcare utilization and medication use.

The Aging Brain Care Virtual (ABCV) program is a 12-month embedded, cluster randomized, usual care controlled trial designed to test the effectiveness of a virtual dementia collaborative care program in 24 Indiana University Health primary care clinics (12 intervention, 12 control) across the state of Indiana, enrolling 860 persons living with dementia (430 intervention, 430 control) and their care partners. ABCV relies on a tailored approach in which dyad needs are identified during virtual visits and addressed with standardized protocols previously tested in a randomized controlled trial delivered in person. The ABCV trial will measure emergency department utilization (primary outcome) and appropriate medication use (secondary outcome) at 12 months using electronic medical record data. Additionally, this study will use semi-structured interviews with care partners and clinicians to explore the implementation context, process and outcomes of the ABCV program.

Ethics approval was obtained from the Indiana University Institutional Review Board (20249). Research findings will be published in peer-reviewed journals and presented at scientific conferences.

NCT06245499.

Fractures over venous sinuses (FOVSs) are associated with difficulties in diagnosis and treatment resulting in a high level of morbidity and mortality. Despite its importance, there are limited aggregate data to guide the management of these fractures ultimately inflicting a major callenge to neurosurgeons. This protocol describes the methodology of a scoping review that aims to synthesise contemporary evidence on the management and outcomes of FOVSs.

The proposed study will be conducted in accordance with the Arksey and O’Malley’s framework for scoping reviews. The research question, eligibility criteria and search strategy were developed based on the population, intervention, comparator and outcome strategy. The following electronic bibliographic databases will be searched without restrictions on language and date of publication: PubMed, WHO Global Index Medicus, African Journals Online, SCOPUS, Embase, Cochrane and ProQuest Central. All peer-reviewed studies of primary data reporting on the management and outcomes of FOVSs will be included. The data extracted from included articles will be presented through descriptive statistics, pooled statistics and a narrative description.

Because this study did not directly involve human individuals, ethical approval was not necessary. Dissemination strategies will include publication in a peer-reviewed journal, oral and poster presentations at local, regional, national and international conferences and promotion over social media.

Type 1 diabetes mellitus (T1DM) is a chronic illness affecting children and adolescents worldwide. Mobile health apps (MHAs) are increasingly used to deliver structured educational interventions (SEI) aimed at reducing glycated haemoglobin (HbA1c), enhancing self-efficacy and self-management in adolescents with T1DM. This review and meta-analysis assessed the effectiveness of SEI via MHAs on HbA1c and self-efficacy in adolescents with T1DM.

Systematic review and meta-analysis.

PubMed, Pak Medinet, Cumulative Index of Nursing and Allied Health Literature (CINAHL), Wiley Online Library and host database Offshore Vessel Inspection Database (OVID) were searched from 1 January 2013 to 30 December 2023.

Randomised controlled trials and quasi-experimental studies (QES) conducted in adolescents aged 10–19 years with T1DM that evaluated the effectiveness of SEIs delivered through mobile app on HbA1c and self-efficacy were included.

Two independent reviewers screened the abstracts and articles by assuring standardised methods. Quality of the studies was assessed using the Joanna Briggs Institute Critical Appraisal Tools for randomised controlled trials (RCTs) and QESs. The meta-analysis was conducted using a random-effects model.

Eight studies met the inclusion criteria, with 555 adolescents aged 10–19 years. The study duration ranged from 7 to 48 weeks. Meta-analysis showed no significant difference in HbA1c at 3 months between the MHAs and control groups (Hedge’s g: –0.03, 95% CI: –0.37 to 0.31, p=0.86). Study heterogeneity was moderate (I²=45%) with no publication bias (Begg’s test p>0.99). Self-efficacy outcomes were inconclusive, with only one RCT reporting improvement in the intervention group and two QES studies showing mixed results.

SEI via MHAs did not significantly affect HbA1c levels in adolescents with T1DM compared with those in the controls. We recommend conduction of well-designed RCTs with larger sample sizes, standardised measurements and tailored educational components to better determine the effectiveness of SEI via MHAs in adolescents.

CRD42024537942.

Young-onset type 2 diabetes (YOD), diagnosed before 40 years of age, entails a high disease burden and potential for early dependence on disability benefits. The risk of type 2 diabetes (T2D) varies with socio-economic status and ethnic background, yet the relationship between these factors and age at diagnosis is insufficiently explored. We aimed to study associations between YOD and living on disability benefits, educational level and country background.

Cross-sectional data on 8640 individuals with T2D, linked to data on educational level and country background, were compared with population data from the same residential areas. Similar comparisons were made for data on disability benefits among 3854 individuals of working age (

The risk of being dependent on disability benefits was three times higher in YOD (adjusted incidence rate ratio, aIRR (95% CI) 3.1 (2.7 to 3.5)) and twice as high in later-onset T2D (1.9 (1.8 to 2.1)) as in the general population. People of Norwegian background with low educational levels had threefold higher YOD risk (3.3 (2.4 to 4.4)) than those with a tertiary degree, while people of non-Western backgrounds with low educational levels had a smaller increase in YOD risk (1.5 (1.1 to 2.1)). People of non-Western backgrounds had higher YOD risk than those of Norwegian background (4.2 (3.5 to 5.0)), while people of south Asian background had an even greater relative YOD risk (9.0 (7.3 to 11.0)), threefold higher than for later-onset T2D (3.2 (2.8 to 3.7)).

Lifetime risk of being dependent on disability benefits was substantially higher for individuals with YOD than in later onset T2D. Non-Western and particularly south Asian backgrounds were associated with increased YOD risk. Low education was an important YOD risk factor only for people with Norwegian background.

To explore the opportunities, challenges and perceived strategies for the uptake of OraQuick HIV self-testing (HIVST) among female sex workers in Ethiopia.

A phenomenological study design, with the Integrated Behavioural Model used as a framework for analysis and interpretation.

Woldia, North Wollo, Ethiopia, 13–30 February 2024.

Twenty female sex workers and 18 key informants in Woldia participated in in-depth interviews, key informant interviews and focus group discussions.

The advantages related to OraQuick HIVST include its privacy, ease of use, reduced waiting time, lowered transportation costs, usability for immobile individuals, application in screening for index case testing programmes, providing confidence and reliability and the elimination of the need for healthcare providers during testing. Perceived possible challenges for the uptake of OraQuick HIVST included kit shortage, absence of policies or guidelines for HIVST, lack of post-test counselling and immediate treatment for positive individuals, potential psychological trauma such as suicidal ideation or attempts, lack of linkage to care for those with reactive results, inaccurate reporting of positive results or result concealment and doubts about reliability before education. Strategies perceived for enhancing the uptake of OraQuick HIVST included making the HIVST kit accessible to higher education communities, addressing HIVST-related doubts by including phone or email contact information, advocating and creating awareness about OraQuick HIVST and ensuring the availability of kits in easily accessible locations.

The study findings highlight many positive opportunities related to the uptake of OraQuick HIVST. Policymakers should prioritise addressing the challenges identified and implementing the proposed strategies to enhance the uptake of OraQuick HIVST, potentially leading to improved HIV testing rates and outcomes.

To assess cervical cancer screening positivity rates, follow-up rescreening uptake 1 year after treatment and persistent positivity among women with initial positive screening results in Ethiopia. The study also explored reasons for loss to follow-up and preferences for reminder strategies.

Longitudinal cross-sectional study.

10 primary healthcare facilities in Oromia and southern and central Ethiopia.

From November 2022 to April 2024, 17 586 women screened for cervical cancer. Of these 768 (4.4%) had positive screening results, and 515 women treated at the primary level were included to assess follow-up rescreening uptake. An additional 139 women who did not return for follow-up were interviewed to identify reasons for non-uptake and reminder preferences.

Of the 515 women included in the analysis, 179 (34.8%, 95% CI: 30.6% to 38.8%) returned for follow-up rescreening. Among those re-screened, the persistent visual inspection with acetic acid (VIA) positivity rate was 16.1% (95% CI: 11.0% to 21.7%). Factors significantly associated with follow-up rescreening uptake included age over 40 (adjusted OR (AOR): 2.5; 95% CI: 1.34 to 5.00), urban residence (AOR: 1.7; 95% CI: 1.15 to 2.58), secondary or higher education (AOR: 2.0; 95% CI: 1.06 to 4.12) and HIV-positive status (AOR: 2.4; 95% CI: 1.27 to 4.87). Among the 139 women contacted, the main reasons for non-uptake were lack of time, forgetting appointments, visiting another facility and pregnancy. Regarding preferred reminders, 93% favoured text messages and all agreed to phone calls or home visits.

One-third of women adhered to follow-up rescreening after a positive cervical cancer screening in Ethiopia, revealing a considerable gap since those women had a three times higher chance of being VIA positive compared with the first screening. Older age, urban residence, higher education and HIV-positive status were significantly linked to follow-up rescreening uptake. Addressing barriers such as time constraints and forgotten appointments through tailored reminder strategies is essential for improving the follow-up rescreening uptake. Contextualised interventions can strengthen rescreening for finding those women at very high risk for cervical lesions and strengthen cervical cancer prevention in Ethiopia.

NCT06515301.