The efficacy of face masking for the public is not convincing to prevent the transmission of respiratory tract viruses such as SARS-CoV-2 when the criteria of evidence-based medicine are applied. This finding is mainly explained by the results from randomized-controlled trials (RCTs) when a high prevalence of the infection and a high compliance in mask wearing was assured. Throughout these studies no significant protective effect was observed. Observational studies with surgical masks describe a significant protective effect, but are prone to confounders such as physical distance. Respirators do not provide an additional health benefit compared to surgical or medical masks (RCTs). Community masks can even increase the risk of infection (RCTs). Based on the categories of evidence-based medicine, the efficacy results can best be categorized as conflicting evidence. Many relevant adverse events are described when masks are worn for hours such as dyspnea (12.2-52.8%), headache (3.9-73.4%), pruritus (0.0-60.0%), and skin reactions (0.0-85.0%). Their frequency is often higher with respirators. In future pandemics, masks should only be recommended or mandated for settings in which a clinically relevant health benefit can be expected, defined as the prevention of severe, critical or fatal disease, that clearly outweighs the expectable associated adverse reactions.

UNASSIGNED: Integrating music into pain treatment demonstrates significant benefits, effectively reducing subjective pain levels and perioperative opioid requirements. Currently, the relationship between the impact of specific types of music and listeners\' socio-cultural background is still unclear. This is especially relevant given that sociological research indicates that these factors can have a notable influence on music preference and perception. Current evidence suggests that individuals who choose their own music may experience greater benefits. However, additional research is needed to comprehensively grasp whether the effect of (preferred) music on pain endurance remains consistent across different socio-cultural backgrounds.
UNASSIGNED: In this study, a collaborative effort between medical and sociological researchers aims to investigate music-induced analgesia differentiated by socio-cultural background in healthy volunteers. Participants (n = 84) will listen to self-, and researcher-chosen music and a podcast as a control condition in a cross-over study design. The primary outcome of this study is pain endurance measured by electric stimuli of increasing intensity. Detailed sociological validated questionnaires will be utilized. Considering the notable influence of educational level on music taste formation found in previous research and its crucial role as a source of socio-cultural differentiation, participants will be stratified based on their level of education.
UNASSIGNED: This experimental study represents one of the first efforts to gain a socio-culturally differentiated understanding of the therapeutic potential of music. Consequently, this could pave the way to purposefully and inclusively implement personalized music in healthcare settings.

BACKGROUND: Unemployment affects millions of people worldwide and, beyond its economic impact, has severe implications for people\'s well-being and mental health. Different programs have been developed in response to this phenomenon, but to date, job-search interventions have proved to be most effective, especially the JOBS II program. The JOBS II program proved not only to be effective for re-employment but also has a positive impact on beneficiaries\' mental health (ie, reduces anxiety or depression). However, by now, this evidence-based program has been delivered only on site in the various countries where it was implemented. In the digital era, web-based alternatives to such programs are highly needed because they have the advantages of scalability and cost-effectiveness.
OBJECTIVE: In this context, we aim to investigate the efficacy of iJobs, the web-based adaptation of the JOBS II program, on job-search intensity and effort, the quality of job-search behaviors, and job-search self-efficacy. Further, 1 month after the intervention, we will also assess the employment status and the satisfaction with the job (if applicable). This study will also investigate the effect of iJobs on well-being and mental health (ie, anxiety and depression).
METHODS: This study is a 2-arm randomized controlled trial. The 2 independent groups (intervention vs waiting list control group) will be crossed with 3 measurement times (ie, baseline, the postintervention time point, and 1-month follow-up). The design will be a 2 (intervention vs control) × 3 (baseline, the postintervention time point, and 1-month follow-up) factorial design. iJobs is a 2-week intervention consisting of 6 modules: an introductive module and 5 modules adapted from the original JOBS II program to the web-based setting and Romanian population. The web-based intervention also has a human component, as beneficiaries receive personalized written feedback after each module on the platform from a team of psychologists involved in the project.
RESULTS: The enrollment of study participants started in June 2023 and is expected to end in May 2024. The data collection is expected to be completed by July 2024. The results are expected to be submitted for publication in the summer of 2024.
CONCLUSIONS: This study is the first large-scale randomized controlled trial aiming to test the efficacy of a web-based adaptation of the JOBS II program. If our results support the efficacy of iJobs, they will offer the premise for it to become an evidence-based, accessible alternative for unemployed people in Romania and might be implemented in other countries.
BACKGROUND: ClinicalTrials.gov NCT05962554; https://clinicaltrials.gov/study/NCT05962554.
UNASSIGNED: PRR1-10.2196/55374.

Dementia negatively affects the wellbeing of both caregivers and care recipients. Community-based therapeutic choir singing offers opportunities for music participation and social engagement that are accessible and mutually enjoyable for people with dementia and their family caregivers and promotes shared and meaningful musical interactions, which may support relationship quality. This study aimed to investigate the impact of the Remini-Sing therapeutic choir intervention on relationship quality, quality of life, depression, and social connectedness for dyads, as well as caregiver burden and care recipient anxiety. A randomized-controlled trial design was used with a target sample of 180 dyads. Due to recruitment difficulties, 34 participant dyads were recruited and randomly assigned to a 20-week group singing condition (n = 16) or a waitlisted control group (n = 18). Participant dyads consisted of people with dementia and their family caregivers who resided at home in the community. The Remini-Sing therapeutic choirs were held in community settings. Assessments were conducted by masked assessors at baseline, 11 weeks, and 21 weeks. Twenty-one dyads completed assessments at the primary timepoint (Week 11). Issues with recruitment and retention resulted in an unpowered study with no statistically significant findings. Mean decreases in anxiety and depression for choir participants with dementia were supported by medium to large effect sizes, indicating a potential intervention effect to be explored in future powered studies. Key learnings related to study design are discussed regarding recruitment, retention, participant burden, and sustainability, with recommendations made for future dementia research.

Exercise interventions are nowadays considered as effective add-on treatments in people with schizophrenia but are usually associated with high dropout rates. Therefore, the present study investigated potential predictors of adherence from a large multicenter study, encompassing two types of exercise training, conducted over a 6-month period with individuals with schizophrenia. First, we examined the role of multiple participants\' characteristics, including levels of functioning, symptom severity, cognitive performance, quality of life, and physical fitness. Second, we used K-means clustering to identify clinical subgroups of participants that potentially exhibited superior adherence. Last, we explored if adherence could be predicted on the individual level using Random Forest, Logistic Regression, and Ridge Regression. We found that individuals with higher levels of functioning at baseline were more likely to adhere to the exercise interventions, while other factors such as symptom severity, cognitive performance, quality of life or physical fitness seemed to be less influential. Accordingly, the high-functioning group with low symptoms exhibited a greater likelihood of adhering to the interventions compared to the severely ill group. Despite incorporating various algorithms, it was not possible to predict adherence at the individual level. These findings add to the understanding of the factors that influence adherence to exercise interventions. They underscore the predictive importance of daily life functioning while indicating a lack of association between symptom severity and adherence. Future research should focus on developing targeted strategies to improve adherence, particularly for people with schizophrenia who suffer from impairments in daily functioning.Clinical trials registration The study of this manuscript which the manuscript is based was registered in the International Clinical Trials Database, ClinicalTrials.gov (NCT number: NCT03466112, https://clinicaltrials.gov/ct2/show/NCT03466112?term=NCT03466112&draw=2&rank=1 ) and in the German Clinical Trials Register (DRKS-ID: DRKS00009804.

BACKGROUND: The perioperative antibiotic prophylaxis with 1st or 2nd generation cephalosporins is evidence-based in orthopedic surgery. There are, however, situations with a high risk of prophylaxis-resistant surgical site infections (SSI).
METHODS: We perform a superiority randomized controlled trial with a 10% margin and a power of 90% in favor of the broad-spectrum prophylaxis. We will randomize orthopedic interventions with a high risk for SSI due to selection of resistant pathogens (open fractures, surgery under therapeutic antibiotics, orthopedic tumor surgery, spine surgery with American Society of Anesthesiologists (ASA) score ≥ 3 points) in a prospective-alternating scheme (1:1, standard prophylaxis with cefuroxime versus a broad-spectrum prophylaxis of a combined single-shot of vancomycin 1 g and gentamicin 5 mg/kg parenterally). The primary outcome is \"remission\" at 6 weeks for most orthopedic surgeries or at 1 year for surgeries with implant. Secondary outcomes are the risk for prophylaxis-resistant SSI pathogens, revision surgery for any reason, change of antibiotic therapy during the treatment of infection, adverse events, and the postoperative healthcare-associated infections other than SSI within 6 weeks (e.g., urine infections or pneumonia). With event-free surgeries to 95% in the broad-spectrum versus 85% in the standard prophylaxis arm, we need 2 × 207 orthopedic surgeries.
CONCLUSIONS: In selected patients with a high risk for infections due to selection of prophylaxis-resistant SSI, a broad-spectrum combination with vancomycin and gentamycin might prevent SSIs (and other postoperative infections) better than the prophylaxis with cefuroxime.
BACKGROUND: ClinicalTrial.gov NCT05502380. Registered on 12 August 2022. Protocol version: 2 (3 June 2022).

Obsessive compulsive disorder (OCD) is effectively treated with exposure and response prevention (ERP), yet very few veterans receive ERP for OCD within the Veterans Health Administration (VHA). Veterans are a clinically complex population, and no prior research has evaluated the effectiveness of ERP in veterans with OCD or comorbid OCD and posttraumatic stress disorder (PTSD). Given the limited accessibility of ERP-trained providers within VHA, assessment of video telehealth (VTH) delivery of ERP is warranted.
A sample of 160 veterans with OCD (80 diagnosed with comorbid PTSD) will be randomly assigned to receive up to 16 sessions of ERP or a stress management training control delivered via VTH. Assessments will occur at baseline, posttreatment, and 6-month follow-up. The primary outcome will evaluate the impact of ERP on participants\' functioning, and secondary outcomes will include quality of life and OCD symptoms. At posttreatment, qualitative interviews with veterans, clinicians, and administrators will explore barriers and facilitators to treatment delivery, and the implementation potential of ERP.
Results will provide direction for the treatment of OCD and comorbid PTSD in veterans, as well as guidance for future implementation efforts for ERP within VHA.
gov Identifier:NCT05240924.

BACKGROUND: Asthma is a chronic respiratory disease with symptoms of attacks of wheezing, shortness of breath, & tightness in the chest. Even with pre-existing treatment exacerbations go uncontrolled.
OBJECTIVE: This study compared asthma control in yoga intervention versus non-yoga intervention group using Asthma Control Test.
METHODS: In this randomized controlled trial, participants were allocated into two groups in 1:1 ratio - yoga intervention versus non-yoga intervention. Only outcome assessor was blinded. Sample size of 200 was calculated. Individuals between 18 and 60 years of age, diagnosed with mild to moderate asthma with no exacerbation in past one month were screened and enrolled. Per-protocol analysis was done to assess the outcomes of Asthma Control Test and expenditure.(CTRI/2020/02/023534) RESULTS: A total of 192 participants enrolled, 165 completed this study who were considered for final analysis. A significant difference (p < 0.001) was found between yoga and non-yoga exercise group at 13 weeks. Expenses were more in non-yoga exercise group.
CONCLUSIONS: Our findings confirm that yoga exercise with routine medical care reduces exacerbations and improves asthma control.

Suicidal ideation and suicide attempts present a serious public health concern among adolescents and young adults. School-based suicide prevention programs are a key tool for addressing this problem. However, more research is necessary to assess their effectiveness, acceptability, and safety. In response, the HEYLiFE suicide prevention program was developed to enhance help-seeking, reduce stigma towards suicidal peers and diminish risk factors for suicidality. This article presents the evaluation findings of the HEYLiFE program in German secondary schools.
We conducted a randomized-controlled trial measuring short-term pre-post within-group effects in the intervention group only and mid-term effects at 6-months-follow-up compared to a waitlist-control group. Schools were assigned randomly to the intervention or control group (no blinding). We recruited students ≥12 years of age. Primary outcomes were knowledge about suicidality, attitudes towards suicidality, stigma towards a suicidal peer, help-seeking intentions and behaviours, risk factors for suicidality. The data was analysed with linear mixed models and generalized linear mixed models.
A total of N = 745 students participated (n = 353 intervention group, n = 392 control group). We observed favourable short-term effects on knowledge, attitudes towards suicidality and fear towards a suicidal peer. Unexpectedly, the program also led to an increase in desire for social distance and a decrease in prosocial emotions towards a suicidal peer. The mid-term effects of the program were exclusively favourable, resulting in enhanced attitudes towards help-seeking while protecting from a sharper rise in risk-factors for suicidality and from an increase in social distance. The program had more favourable effects on females and on students aged >13 years. The program was well-received by the students, and no serious adverse events were reported.
These findings demonstrate the effectiveness of the HEYLiFE universal suicide prevention program in addressing variables associated with suicidal ideation and suicide attempts among adolescents on the mid-term. The short-term negative effects on stigma and more negative effects on males should be addressed in the future. Future evaluation studies should examine its effects on suicidality and its effectiveness within populations at high risk.
The study was preregistered in the German Clinical Trials Register (registration number: DRKS00017045; registration date: 02/04/2019).

There is no established treatment for patients with clozapine-resistant schizophrenia (CRS). Clozapine augmentation strategies with antipsychotics or others substances are effective in comparison with placebo while and Electroconvulsive therapy (ECT) showed to be effective in comparison with treatment as usual (TAU) but not with placebo (sham-ECT). In the present double- blind randomized controlled trial, we compared 40 outpatients who received 20 sessions of ECT (n = 21) or sham-ECT (n = 19) (age = 37.40 ± 9.62, males = 77.5 %, illness duration = 14.95 ± 8.32 years, mean total Positive and Negative Syndrome Scale (PANSS) = 101.10 ± 24.91) who fulfilled well-defined CRS criteria including baseline clozapine plasma levels ≥350 ng/mL. The primary outcome was the ≥50 % PANSS Total Score reduction; secondary outcomes were the scores of the PANSS subscales, PANSS five-factor dimensions, PANSS-6 and the Calgary Depression Rating Scale (CDRS). Treatment response was analyzed by percentage reduction, Linear Mixed Models and effect sizes. At baseline both groups showed no differences except for years of school education (included as a covariate). At endpoint, only 1/19 of the completers (5.26 %) in the ECT group and 0/17 in the sham-ECT group showed a ≥50 % total PANSS score reduction. Both groups showed no significant differences of the total PANSS score (F = 0.12; p = 0.73), Positive (F = 0.27, p = 0.61), Negative (F = 0.25, p = 0.62), and General Psychopathology scores (F = 0.01, p = 0.94) as well for all PANSS five factors, the PANSS-6 and CDRS. Thus, the present study found no evidence that ECT is better than Sham-ECT in patients with CRS. Future sham-ECT controlled studies with larger sample sizes are warranted to test the efficacy of ECT for patients with CRS.