An online solution focused brief therapy for adolescent anxiety : A randomized controlled trial.

In this randomized clinical trial, we investigated the efficacy of an online solution focused brief therapy (SFBT) for adolescents' anxiety symptoms during the COVID-19 period. Eligible participants were between the ages of 11 and 18 years, scored a 10 or above on the Generalized Anxiety Disorder-7 (GAD-7). The results found that compared to adolescents who did not receive any treatment, the intervention yielded significant results in alleviating adolescents' anxiety and depressive symptoms while promoting problem oriented coping strategies at immediate post-intervention. The therapeutic benefit has persisted, as shown in our results from the 1-month follow-up.

Investigating the efficacy of baricitinib in new onset type 1 diabetes mellitus (BANDIT)-study protocol for a phase 2, randomized, placebo controlled trial.

BACKGROUND: Type 1 diabetes (T1D) places an extraordinary burden on individuals and their families, as well as on the healthcare system. Despite recent advances in glucose sensors and insulin pump technology, only a minority of patients meet their glucose targets and face the risk of both acute and long-term complications, some of which are life-threatening. The JAK-STAT pathway is critical for the immune-mediated pancreatic beta cell destruction in T1D. Our pre-clinical data show that inhibitors of JAK1/JAK2 prevent diabetes and reverse newly diagnosed diabetes in the T1D non-obese diabetic mouse model. The goal of this study is to determine if the JAK1/JAK2 inhibitor baricitinib impairs type 1 diabetes autoimmunity and preserves beta cell function. METHODS: This will be as a multicentre, two-arm, double-blind, placebo-controlled randomized trial in individuals aged 10-30 years with recent-onset T1D. Eighty-three participants will be randomized in a 2:1 ratio within 100 days of diagnosis to receive either baricitinib 4mg/day or placebo for 48 weeks and then monitored for a further 48 weeks after stopping study drug. The primary outcome is the plasma C-peptide 2h area under the curve following ingestion of a mixed meal. Secondary outcomes include HbA1c, insulin dose, continuous glucose profile and adverse events. Mechanistic assessments will characterize general and diabetes-specific immune responses. DISCUSSION: This study will determine if baricitinib slows the progressive, immune-mediated loss of beta cell function that occurs after clinical presentation of T1D. Preservation of beta cell function would be expected to improve glucose control and prevent diabetes complications, and justify additional trials of baricitinib combined with other therapies and of its use in at-risk populations to prevent T1D. TRIAL REGISTRATION: ANZCTR ACTRN12620000239965 . Registered on 26 February 2020. CLINICALTRIALS: gov NCT04774224. Registered on 01 March 2021.

The efficacy of online mindfulness-based interventions in a university student sample: Videoconference- or podcast-delivered intervention.

The increasing mental health issues among university students during the COVID-19 pandemic and the challenges of delivering face-to-face interventions during lockdowns have increased the demand for online interventions. The report presents results from a randomized controlled trial investigating the benefits of online mindfulness interventions delivered by videoconference or podcast during the early phase of the pandemic in Germany. Fifty university students were randomized to a mindfulness intervention conducted by videoconference (n = 25) or to an unguided training provided by podcasts (n = 25). All students participated in a 7-week mindfulness intervention. Outcome measures included mindfulness, depression, anxiety, and life satisfaction preintervention and postintervention. The study showed a larger reduction in depression in the videoconferencing group than in the podcast group across per protocol (PP) and intention-to-treat (ITT) analyses. There was a significant increase in mindfulness (PP and ITT samples) and life satisfaction (ITT sample) in both groups. The frequency of home practice was related to positive changes in outcomes but only for the videoconferencing group. The results suggest that mindfulness training delivered via videoconferencing can be a viable option to address depressive symptoms among students. However, both interventions were effective in increasing mindfulness and life satisfaction.

Effects of an automatized psychological inoculation (PI) intervention on anxiety, resilience and adherence to COVID-19 recommendations.

OBJECTIVES: The covid-19 pandemic calls for adherence to multiple health behaviours. While authorities mostly use health information to deal with these issues, such an approach may be insufficient. This study examined the effects of a cognitive method, namely psychological inoculation (PI) + health information (experimental) versus health information alone (control) on anxiety, resilience and adherence. DESIGN: A randomized controlled trial was used. Participants were assigned to the experimental or control conditions, all provided on an automatized computerized system. MAIN OUTCOME MEASURES: These included anxiety, adherence to the Covid-19 Israeli health ministry's recommendations, and mental resilience. Participants were assessed before, immediately after and a week after the interventions. RESULTS: Controls increased only in adherence at 1 week compared to baseline. In contrast, those in the PI increased in resilience and adherence and reported lower anxiety immediately after treatment compared to baseline levels. In the PI condition, degree of refuting challenging sentences correlated with less anxiety. CONCLUSIONS: Results showed better immediate improvements in anxiety, resilience and intention to adhere in the experimental condition compare to the controls. Authorities may wish to add PI to help the public deal with the effects of such a pandemic and to increase adherence to health recommendations.

The effect of e-health interventions on meeting the needs of individuals with infertility: a narrative review.

Background: The mental health and well-being of millions of people worldwide are negatively impacted by infertility. A promising solution to meet the needs of people suffering from infertility is e-health interventions, such as online counseling and support groups. This study aims to review the current literature on e-health interventions and how they impact people with infertility. Main body of the abstract: Relevant studies were searched in PubMed, Web of Science, and Scopus databases. Articles were entered into the EndNote software and screened for duplicates and relevance. Two authors then reviewed full-text articles independently, with a third person resolving any disagreements. Thirteen studies conducted between 2007 and 2022 were identified. The interventions aimed to meet various needs, including training on drug use (n = 23), lifestyle modifications (n = 1), periconceptional behavior modifications (n = 1), drug management (n = 1), IVF training (n = 4), psychological support to reduce distress (n = 4), and promoting a positive sexual self-concept (n = 1). Short conclusion: The limited number of e-health interventions for infertile patients, the heterogeneity of interventions, and the lack of long-term effectiveness data make it challenging to compare e-health interventions to nonelectronic alternatives. However, the increasing use of technology in healthcare, especially during and after the Covid-19 pandemic, suggests that e-health educational interventions such as those using the Internet, psychological support, and patient interaction will continue to play a crucial role in healthcare. Supplementary Information: The online version contains supplementary material available at 10.1186/s43043-023-00137-7.

Effectiveness of mindful walking intervention in nature on sleep quality and mood among university student during Covid-19: A randomised control study.

OBJECTIVE: The aim of this project was to conduct a randomised control study to examine whether outdoor mindful walking in nature can effectively improve university students' sleep quality, mood, and mindfulness during the lockdown of Covid-19 pandemic in the U.K. METHODS: Participants were measured at T0 (pre-study baseline), T1 (pre-intervention), T2 (post-intervention), and T3 (follow-up). A total of 104 participants (female = 94) who were experiencing sleep difficulties were randomly allocated to either an experimental (i.e., nature) or control (i.e., urban) walking environments. Participants in each walking condition independently undertook a daily 35-minute walk for a week (7 days). Subjective sleep quality, total mood disturbance, mindfulness, and degree of nature, and participants' perspectives and suggestions about the intervention, were collected. RESULTS: Findings suggest that both groups exhibited significant improvements on participant's trait mindfulness, sleep quality and mood after the intervention. However, mindful walking in nature did not bring additional mental health benefits to participants than those who walked in urban environment. Participants reflected their perspectives about the intervention, which will assist with further intervention development. CONCLUSIONS: Findings contribute to the evidence base for the effectiveness of outdoor mindful walking interventions on mental health. Especially these findings add new knowledge of how mindful walking outdoors reduces university students' mood disturbances and improves their sleep quality and mindfulness level during the pandemic.

A Narrative Review of Emerging Therapeutics for COVID-19.

The novel severe acute respiratory syndrome coronavirus 2, the causal agent of coronavirus disease 2019 (COVID-19), quickly spread around the world, resulting in the most aggressive pandemic experienced in more than 100 years. Research on targeted therapies and vaccines has been initiated on an unprecedented scale and speed but will take months and even years to come to fruition. Meanwhile, the efficacy of emerging therapeutics for use in treating COVID-19 is feverishly being investigated to identify the best available treatment options for dealing with the current wave of disease. This review of publications with a "treatment" tag through June 29, 2020 in the National Library of Medicine's LitCovid literature hub, provides frontline clinicians with a pragmatic summary of the current state of the rapidly evolving evidence supporting emerging candidate therapeutics for COVID-19. Two main categories of pharmaceutical therapeutics are showing promise: those with antiviral activity directly addressing infection and those that counteract the inflammatory cytokine storm induced by severe disease. Preliminary results suggest that other approaches such as convalescent plasma therapy and lung radiation therapy may have some efficacy. The current clinical evidence for potential treatments is preliminary-often small retrospective series or early results of randomized trials-and the science is evolving rapidly. The long-term results from large, well-designed randomized controlled trials will provide definitive evidence for therapeutic effectiveness and are likely months away. The trial landscape for promising therapies is described.

Evaluation of a workplace suicide prevention program in the Australian manufacturing industry: protocol for a cluster-randomised trial of MATES in manufacturing.

Males are at higher risk of death by suicide than females in Australia, and among men, blue-collar males are at higher risk compared to other working males. In response, MATES in Construction developed a workplace suicide prevention program for the construction sector in 2007 that has been widely implemented in Australia. In the current project, this program is being adapted and trialled in the manufacturing sector. The common aims of MATES programs are to improve suicide prevention literacy, help-seeking intentions, and helping behaviours. The program will be evaluated using a cluster randomised-controlled trial design with waitlist controls across up to 12 manufacturing worksites in Australia. We hypothesise that after 8 months of the MATES in Manufacturing program, there will be significantly greater improvements in help-seeking intentions (primary outcome) compared to waitlist controls. The project is led by Deakin University in collaboration with the University of Melbourne, and in partnership with MATES in Construction and a joint labour-management Steering Group.Trial registration: The trial was registered retrospectively with the Australian New Zealand Clinical Trials Registry on 25 January 2022 (ACTRN12622000122752).Protocol version: 2.0, November 2022.

Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare): an updated study protocol for a parallel arm cluster randomised controlled trial.

The "Diabetes: Community-led Awareness, Response and Evaluation" (D:Clare) trial aims to scale up and replicate an evidence-based participatory learning and action cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control.The trial was originally designed as a stepped-wedge cluster randomised controlled trial, with the interventions running from March 2020 to September 2022. Twelve clusters were randomly allocated (1:1) to implement the intervention at months 1 or 12 in two steps, and evaluated through three cross-sectional surveys at months 1, 12 and 24. However, due to the COVID-19 pandemic, we suspended project activities on the 20th of March 2020. As a result of the changed risk landscape and the delays introduced by the COVID-19 pandemic, we changed from the stepped-wedge design to a wait-list parallel arm cluster RCT (cRCT) with baseline data. We had four key reasons for eventually agreeing to change designs: equipoise, temporal bias in exposure and outcomes, loss of power and time and funding considerations.Trial registration ISRCTN42219712 . Registered on 31 October 2019.

Effect of an educational intervention on diet and physical activity among school-aged adolescents in Delhi -The i-PROMISe (PROMoting health literacy in Schools) Plus Study.

Purpose: Emerging lifestyle changes due to rapid urbanization have led to an epidemiological transition and the rising prevalence of obesity is responsible for major non-communicable diseases (NCDs) which have further aggravated due to the COVID-19 pandemic. This study aims to assess the effectiveness of a comprehensive school-based intervention on diet and physical activity-related behavior of adolescents. Methods: In 2019, a cluster-randomized controlled trial was conducted in randomly selected (n = 8) private schools. A 2-year intervention program was implemented over consecutive academic years (2019-2020 and 2020-2021) with students who were in the 6th and 7th grades when the study began. Four schools were randomly assigned to the intervention (n = 794) and four schools to the control group (n = 774). Results: The difference in changes in diet and physical-activity-related behaviors of the students between the intervention and control schools were not significant in the intention to treat analysis probably due to the large drop-out due to COVID-19 measures: 304 students were available for follow-up in the intervention group and 122 in the control group (391 cases were excluded to make data comparable with baseline survey). The intake of vegetables (once a day) [ß = 0.35, OR = 1.42, 95% CI (1.03, 1.95)] in the per-protocol analysis has increased among adolescents in the intervention group as compared to the control group. Conclusion: The findings of this study indicated a positive effect of the intervention on diet and physical-activity-related changes in the expected direction and highlights the importance of addressing such behavior to prevent obesity among adolescents and thus NCDs in the later stage of life.

Evaluation of eHealth assistance in-hospital care for improved quality of life in patients.

Health conditions contribute significantly to patients' quality of life. Healthcare infrastructure and healthcare services, including their accessibility, belong to objective factors influencing their perception of their health. The growing disparity between supply and demand for specialized inpatient facilities due to the aging population calls for new solutions, including eHealth technologies. Automatized activities could be taken over by eHealth technologies that do not require a constant presence of staff. We tested whether eHealth technical solutions reduce patients' health risks on a sample of 61 patients on the covid-19 unit in Tomas Bata hospital in Zlin. We have applied the randomized control trial to select patients for the treatment and the control groups. Moreover, we tested eHealth technologies and their help to staff in the hospital. Due to the severity of the covid-19 disease and its rapid course and the size of the sample in our research, we did not demonstrate a statistically significant impact of eHealth technologies on patient health. The evaluation results confirm that even the limited number of technologies deployed proves to be an effective help for staff in critical situations like the pandemic. The main issue is psychological support to staff in hospitals and relieving stressful work.

The Effectiveness of Electrical Vestibular Stimulation (VeNS) on Symptoms of Anxiety: Study Protocol of a Randomized, Double-Blinded, Sham-Controlled Trial.

The prevalence of symptoms of anxiety is increasing, especially during the COVID-19 pandemic. A home use transdermal neurostimulation device might help to minimize the severity of anxiety disorder. To the best of our knowledge, there is no clinical trial using transdermal neurostimulation to treat individuals with symptoms of anxiety in Asia. This gives us the impetus to execute the first study which aims at evaluating the efficacy of Electrical Vestibular Stimulation (VeNS) on anxiety in Hong Kong. This study proposes a two-armed, double-blinded, randomized, sham-controlled trial including the active VeNS and sham VeNS group. Both groups will be measured at baseline (T1), immediately after the intervention (T2), and at the 1-month (T3) and 3-month follow-up (T4). A total of 66 community-dwelling adults aged 18 to 60 with anxiety symptoms will be recruited in this study. All subjects will be computer randomised into either the active VeNS group or the sham VeNS group in a 1:1 ratio. All subjects in each group will receive twenty 30 min VeNS sessions during weekdays, which will be completed in a 4-week period. Baseline measurements and post-VeNS evaluation of the psychological outcomes (i.e., anxiety, insomnia, and quality of life) will also be conducted on all participants. The 1-month and 3-month follow-up period will be used to assess the long-term sustainability of the VeNS intervention. For statistical analysis, ANOVA with repeated measures will be used to analyze data. Missing data were managed with multiple mutations. The level of significance will be set to p < 0.05. Results of this study will be used to determine whether this VeNS device can be considered as a self-help technological device to reduce perceived anxiety in the general population in the community setting. This clinical Trial was registered with the Clinical Trial government, identifier: NCT04999709.

Macroeconomic expectations and consumer sentiment during the COVID-19 pandemic: The role of others' beliefs.

This paper investigates the effect of information about cross-country ratings of the government's and the public's reaction to the COVID-19 pandemic on consumers' macroeconomic expectations and sentiment. We conduct consumer surveys with randomized control trials (RCTs) in two waves in Thailand and Vietnam. The information treatments have the strongest effect when the information shown contradicts consumers' prior beliefs. In the first survey, conducted when the first lockdown was eased, treatment effects are stronger in Vietnam, causing more optimistic expectations and sentiment. In the second survey, conducted at the start of the second wave of infections, treatment effects are stronger in Thailand, causing a more pessimistic outlook.

Using Normative Language When Describing Scientific Findings: Randomized Controlled Trial of Effects on Trust and Credibility.

BACKGROUND: Scientists often make cognitive claims (eg, the results of their work) and normative claims (eg, what should be done based on those results). Yet, these types of statements contain very different information and implications. This randomized controlled trial sought to characterize the granular effects of using normative language in science communication. OBJECTIVE: Our study examined whether viewing a social media post containing scientific claims about face masks for COVID-19 using both normative and cognitive language (intervention arm) would reduce perceptions of trust and credibility in science and scientists compared with an identical post using only cognitive language (control arm). We also examined whether effects were mediated by political orientation. METHODS: This was a 2-arm, parallel group, randomized controlled trial. We aimed to recruit 1500 US adults (age 18+) from the Prolific platform who were representative of the US population census by cross sections of age, race/ethnicity, and gender. Participants were randomly assigned to view 1 of 2 images of a social media post about face masks to prevent COVID-19. The control image described the results of a real study (cognitive language), and the intervention image was identical, but also included recommendations from the same study about what people should do based on the results (normative language). Primary outcomes were trust in science and scientists (21-item scale) and 4 individual items related to trust and credibility; 9 additional covariates (eg, sociodemographics, political orientation) were measured and included in analyses. RESULTS: From September 4, 2022, to September 6, 2022, 1526 individuals completed the study. For the sample as a whole (eg, without interaction terms), there was no evidence that a single exposure to normative language affected perceptions of trust or credibility in science or scientists. When including the interaction term (study arm × political orientation), there was some evidence of differential effects, such that individuals with liberal political orientation were more likely to trust scientific information from the social media post's author if the post included normative language, and political conservatives were more likely to trust scientific information from the post's author if the post included only cognitive language (ß=0.05, 95% CI 0.00 to 0.10; P=.04). CONCLUSIONS: This study does not support the authors' original hypotheses that single exposures to normative language can reduce perceptions of trust or credibility in science or scientists for all people. However, the secondary preregistered analyses indicate the possibility that political orientation may differentially mediate the effect of normative and cognitive language from scientists on people's perceptions. We do not submit this paper as definitive evidence thereof but do believe that there is sufficient evidence to support additional research into this topic, which may have implications for effective scientific communication. TRIAL REGISTRATION: OSF Registries osf.io/kb3yh; https://osf.io/kb3yh. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/41747.

The applicability and efficacy of Micro-Video Psychological Training Camp in groups with mild to moderate symptoms of depression and anxiety: A prospective and randomized controlled trial protocol.

Background: Mental health is a global issue requiring global attention. Depression and anxiety are two of the most common mental disorders (CMDs) and are characterized by high incidence and high comorbidity. In recent years, the prolonged COVID-19 pandemic and exacerbated social instability have posed significant challenges to the mental resilience and mental health outcomes of the global population. Now more than ever, with an increase in mental health needs, it has become even more crucial to find an effective solution to provide universal mental healthcare. Psychotherapy is of vital importance for those coping with symptoms of depression and anxiety and is used to enhance mental resilience. However, such therapy can be difficult to access in reality. In this context, the Micro-Video Psychological Training Camp (MVPTC) platform will be developed. Objectives: As an online self-help platform for psychological intervention, the MVPTC platform was developed for those who suffer from mild to moderate symptoms of depression and/or anxiety and is tasked with the goal of reducing depressive and anxious symptoms while improving mental resilience. Thus, this study will be carried out to verify its efficacy and applicability. Methods: In this parallel-group, randomized controlled trial, a total of 200 mild to moderately depressed and/or anxious adults seeking self-help will be randomly recruited and assigned to either the micro-video psychological intervention group or the wait list control group. Online measurements by self-assessment will be taken at baseline, post-intervention, 1-month, and 3-month follow-up. Results: The primary results will involve symptoms of depression and anxiety. The secondary results will involve mental resilience. An analysis will be conducted based on the intention-to-treat principle. Discussion: This trial will examine whether the MVPTC platform for the relief of symptoms and the enhancement of resilience in a population screened for depression and anxiety symptoms proves effective and applicable. Large-scale resilience enhancement may benefit public mental health in terms of preventive interventions, managing depressive and anxiety symptoms, and promoting mental health. With the MVPTC-based method being applied, a brief, efficient, and structured intervention model can potentially be established, having the potential to provide necessary and accessible mental support for an extensive target group. Clinical trial registration: http://www.chictr.org.cn/, identifier ChiCTR2100043725.

Combined Application of Dimethyl Sulfoxide and Ethanol Nasal Spray during COVID-19 Pandemic May Protect Healthcare Workers: A Randomized Controlled Trial

Background: Coronavirus pandemic has affected a large population worldwide. Currently, the standard care for individuals who are exposed is supportive care, symptomatic management, and isolation. Objectives: This study aimed to evaluate the effects of the combined use of ethanol and dimethyl sulfoxide (DMSO) as a nasal spray in preventing Coronavirus disease 2019 (COVID-19). Methods: This randomized controlled trial was conducted on volunteer healthcare workers of medical centers who were at the forefront of the fight against COVID-19 in Shahroud, Iran. In total, 232 participants were randomly assigned to intervention and control groups to receive DMSO/ethanol or routine care, respectively. The subjects were followed for four weeks to determine the incidence of COVID-19 infection in each group based on the RT-PCR test. Finally, absolute risk difference and relative risk were calculated to evaluate the effect of DMSO on COVID-19 prevention. Results: The results showed that the incidence rates of COVID-19 were 0.07 and 0.008 in the control and intervention groups, respectively. The relative risk was obtained at 0.12 (0.02-0.97) according to the incidence rate in the two groups. Conclusion: Combined administration of DMSO and ethanol by healthcare providers can considerably prevent COVID-19.

3-day intervention program for family members of hikikomori sufferers: A pilot randomized controlled trial.

Backgrounds: Hikikomori, pathological social withdrawal, is becoming a crucial mental health issue in Japan and worldwide. We have developed a 3-day family intervention program for hikikomori sufferers based on Mental Health First Aid (MHFA) and Community Reinforcement and Family Training (CRAFT). This study aims to confirm the effectiveness of the 3-day program by a randomized controlled trial. Methods: This study was registered on the UMIN Clinical Trials Registry (UMIN000037289). Fifteen parents were assigned to the treat as usual (TAU) group (TAU only; Age Mean, 65.6; SD, 7.8), and 14 to the Program group (program + TAU; Age Mean, 67.9; SD, 8.6). This study was discontinued due to the COVID-19 pandemic; the recruitment rate was 36.3% of our target sample size of 80. Results: Perceived skills improved temporally and stigma temporally worsened in the TAU group. Confidence decreased and attitude showed no change in both groups. Aggressive behaviors of hikikomori sufferers were significantly worsened in the Program group; however, no serious domestic violence was reported. In the TAU group, Avoidance and irregular life patterns were improved. Activity levels were worsened in both groups. Two participants (16.7%) in the Program group and one participant (7.7%) in the TAU group reported actual behavioral changes (e.g., utilizing support). Conclusion: We could not draw general conclusions on the effectiveness of the program due to the study discontinuation. Nevertheless, this study indicates the necessity for revision of the program to improve family members' confidence in engaging with hikikomori sufferers, with safer approaching by families.

Nudge-Based Interventions on Health Promotion Activity Among Very Old People: A Pragmatic, 2-Arm, Participant-Blinded Randomized Controlled Trial.

OBJECTIVES: Social distancing due to the coronavirus disease 2019 crisis can exacerbate inactivity in older adults. Novel approaches for older adults must be designed to improve their activity and maintain their health. This study examined the effect of nudge-based behavioral interventions on health-promoting activities in older adults in Japan. DESIGN: Two-arm, participant-blinded randomized controlled trial. SETTING AND PARTICIPANTS: Japanese continuing care retirement community residents (n = 99, median age 82 years, 73% women) INTERVENTION: Two-step nudge-based behavioral intervention promoting tablet usage. METHODS: We enrolled participants from an ongoing Internet of Things project in a retirement community in Japan. For the health promotion program, tablet computers were installed in a common area for participants to receive information about their health. The intervention group received a 1-time loss-emphasized nudge (first step), followed by asking questions about when they planned to use it again (second step). The control group used the tablet computers without being asked those questions. The main outcome was the participants' mean daily tablet activity every 4 weeks for the next 16 weeks. RESULTS: Ninety-nine individuals were randomly assigned to the intervention or control group. The rate ratios for tablet use were significantly higher in the intervention group in the second and third periods. The subgroup analysis showed that these effects were largely attributable to men. CONCLUSIONS AND IMPLICATIONS: Nudge-based interventions can be effective in promoting activities for older adults, especially older men. The finding of this study indicates a possible intervention to engage people who are socially isolated.

EffEctiveness of Prophylactic fOam dressings in the prevention of saCral pressure injuries in at-risk hospitalised patients: the EEPOC trial.

BACKGROUND: Prophylactic dressings are increasingly used to prevent pressure injuries in hospitalised patients. However, evidence regarding the effectiveness of these dressings is still emerging. This trial aims to determine the clinical and cost-effectiveness of a prophylactic silicone foam border dressing in preventing sacral pressure injuries in medical-surgical patients. METHODS: This is a multicentre, pragmatic, parallel group, randomised controlled trial. A sample size of 1320 was calculated to have >90% power to detect a 5% difference in the primary outcome at an alpha of 0.05. Adult patients admitted to participating medical-surgical wards are screened for eligibility: ≥18 years, admitted to hospital within the previous 36 h, expected length of stay of ≥24 h, and assessed high risk for hospital-acquired pressure injury. Consenting participants are randomly allocated to either prophylactic silicone foam dressing intervention or usual care without any dressing as the control group via a web-based randomisation service independent of the trial. Patients are enrolled across three Australian hospitals. The primary outcome is the cumulative incidence of patients who develop a sacral pressure injury. Secondary outcomes include the time to sacral pressure injury, incidence of severity (stage) of sacral pressure injury, cost-effectiveness of dressings, and process evaluation. Participant outcomes are assessed daily for up to 14 days by blinded independent outcome assessors using de-identified, digitally modified sacral photographs. Those who develop a sacral pressure injury are followed for an additional 14 days to estimate costs of pressure injury treatment. Analysis of clinical outcomes will be based on intention-to-treat, per-protocol, and sensitivity analyses. DISCUSSION: This trial aims to provide definitive evidence on the effect prophylactic dressings have on the development of hospital-acquired sacral pressure injuries in medical-surgical patients. A parallel economic evaluation of pressure injury prevention and treatment will enable evidence-informed decisions and policy. The inclusion of a process evaluation will help to explain the contextual factors that may have a bearing on trial results including the acceptability of the dressings to patients and staff. The trial commenced 5 March 2020 and has been significantly delayed due to COVID-19. TRIAL REGISTRATION: ANZCTR ACTRN12619000763145. Prospectively registered on 22 May 2019.