Trials最新文献

Background: Body dissatisfaction is highly prevalent in Latin America, including Colombia. However, culturally adapted, evidence-based interventions are lacking, although effective programs exist in Western countries. This protocol describes a cluster randomized controlled trial (cRCT) of an intervention to improve media literacy and decrease body dissatisfaction and related outcomes among adolescents in urban and rural schools in Colombia.

Methods: We will recruit 1250 adolescents in 7th-10th grade (aged 11-17 years) to participate in a two-arm, cluster-randomized, open-label, controlled superiority trial in Colombia. Participating schools will be recruited by the research team. Participants will be randomized at the school level (1:1). Randomization blocks stratified by socioeconomic status (high vs. low) and geographical area (rural vs. urban) will be used to assign schools to either: (a) a school-based, four-session group intervention delivered over 2-4 weeks by trained facilitators (n = 625) or (b) a waitlist control group that will receive the intervention only after follow-up (n = 625). Participants need to be aged 11-17 years old, attending a participating school and class in grades 7 to 10, have written parental consent, and give written assent to be eligible for participation in this study. Individuals who cannot understand spoken or written language, or who do not have parental consent to participate, will be excluded. Primary outcomes are media literacy and body dissatisfaction. Secondary outcomes include appearance comparison, thin ideal internalization, curvy ideal internalization (girls only), drive for muscularity (boys only), eating disorder symptoms, and general wellbeing. Additional exploratory outcomes include risky appearance-altering behaviours (girls only), colourism, and skin colour satisfaction. Furthermore, adverse outcomes will be recorded. Outcome assessments will happen pre-intervention (baseline; Timepoint 1), 1-week post-intervention (immediate post-test; Timepoint 2), and 9-12 months post-intervention (follow-up; Timepoint 3).

Discussion: Based on pilot data, we hypothesise that the intervention group will demonstrate increased media literacy and decreased body dissatisfaction at post-test and follow-up. We also anticipate improvements in secondary outcomes. This will be the first cluster RCT to evaluate the effect of a culturally adapted body image intervention in Colombia. This trial has been registered in the ISRCTN Registry (ISRCTN15802562, https://doi.org/10.1186/ISRCTN15802562). First enrolment was on 26th of August 2025.

Trial registration: This trial has been registered in the ISRCTN Registry (ISRCTN15802562, https://doi.org/10.1186/ISRCTN15802562).

Background: A proportion of clinical trials terminate prematurely, due to logistical or conduct issues and emerging scientific data. Due to a paucity of literature and non-standardised reporting, the rate for all trials is unknown, and little is known about the number and experience of healthcare professionals managing this situation. This study aimed to identify how many UK healthcare professionals delivering clinical research have experienced premature trial termination, the challenges experienced and resources available for managing this situation.

Methods: Following ethics approval, a national e-survey of self-identifying healthcare professionals delivering clinical research was conducted (April-September 2022). Analysis included descriptive statistics and content analysis for categorization of challenges.

Results: A total of 65% (n = 89) of healthcare professionals had experienced ≥ 1 premature trial termination. Challenges included communicating with research participants and/or families (n = 20) and emotional distress for participants and/or families (n = 21). Forty-eight healthcare professionals identified resources; of those available for review, one resource provided guidance relating to research participants.

Conclusion: Premature clinical trial termination creates challenges for care delivery and impacts on participants and/or families. Healthcare professionals need preparation and training to ensure participants are appropriately supported if their trial prematurely terminates.

Background: Perioperative sleep disorders (PSDs) in elderly patients under general anesthesia are associated with high morbidity and severely affect patients' prognosis. In recent years, vagus nerve electrical stimulation (VNS) has been shown to treat diseases related to autonomic dysfunction, and its anti-inflammatory and other mechanisms may present potential therapeutic possibilities for sleep disorders. This study aimed to investigate the efficacy of transauricular vagal nerve stimulation in improving sleep disorders in elderly patients.

Methods/design: This is a single-center, prospective, randomized, controlled clinical trial. A total of 164 elderly patients receiving general anesthesia were randomized at a 1:1 ratio into two groups: one receiving electrical vagus nerve stimulation during the perioperative period and the other receiving sham stimulation. The primary outcome was the incidence of perioperative sleep disorders within 3 days postoperatively, which was defined as an Athens Insomnia Scale (AIS) score of ≥ 6 or a numerical rating scale (NRS) score of ≥ 6. Further effectiveness and safety parameters included sleep quality on days 1, 3, and 5 after surgery, the postoperative pain score, the hospital anxiety‒depression score, the incidence of postoperative delirium, and the incidence of related adverse events.

Discussion: This study aimed to investigate the efficacy and feasibility of using taVNS to improve PSD in elderly patients receiving general anesthesia.

Trial registration number: ClinicalTrials.gov NCT06421051. Registered on May 10, 2024.

Protocol version: 1.0: Date: 2024-05-01.

Background: Out-of-hospital cardiac arrest (OHCA) remains a major cause of mortality, with low survival probabilities to hospital discharge. Despite the frequent use of airway management and mechanical ventilation during resuscitation, there is limited evidence regarding the optimal ventilation strategy to improve oxygen delivery and patient outcomes. The present study aims to investigate the effects of positive-end-expiratory-pressure (PEEP) set at 5 mbar compared to zero-end-expiratory-pressure (ZEEP) on the return of spontaneous-circulation (ROSC) in adult patients with OHCA.

Methods: This is a prospective, multicenter, cluster-randomized controlled trial conducted across emergency medical services (EMS) in the regions of Gütersloh, Minden-Lübbecke, and Osnabrück. Adult patients (≥ 18 years) with OHCA who are undergoing mechanical ventilation through an airway device will be enrolled. The clusters (regional districts) will be randomized into two groups: one group will receive ventilation with PEEP set at 5 mbar (intervention group), while the other group will receive ventilation with ZEEP (control group). The study's primary endpoint is the occurence of ROSC. Secondary endpoints include occurence of re-arrest, death during pre-hospital care phase, hospital admission during ongoing resuscitation, hospital admission with spontaneous circulation, peripheral oxygen saturation, and endtidal CO₂ at hospital admission.

Discussion: Optimal ventilation strategies during OHCA have not been well established. The use of PEEP may improve oxygenation and oxygen delivery. This study aims to provide crucial data on whether the application of PEEP at 5 mbar vs. 0 mbar can improve the probability of ROSC without adversely affecting hemodynamics. The findings could inform future guidelines on ventilation strategies in resuscitation.

Trial registration: The trial is registered on ClinicalTrials.gov under the registration number NCT06836830. 24.02.2025 https://clinicaltrials.gov/study/NCT06836830?term=gerrit%20jansen&rank=2 .

Background: Gaming interventions hold promising potential for methods of mental health treatment. Games designed for individuals with serious mental illness have demonstrated high acceptability. They have been shown to improve treatment engagement and increase a sense of self-efficacy and social integration. However, concerns remain over the potential adverse effects of regular gaming. Therefore, to investigate both the benefits and the risks, there is a need for well-designed, -conducted and -reported high-quality trials. This study aims to evaluate the effectiveness of a gaming intervention in improving functional and clinical outcomes in people with psychotic disorders and to assess the feasibility of the intervention.

Methods: The effectiveness of the gaming intervention will be assessed using a controlled clinical trial with a pragmatic, multicentre, two-arm parallel-group design. The participants will be recruited from various types of outpatient units (e.g. outpatient psychiatric units, day hospitals, residential care homes). Following the baseline assessment, participants will be centrally randomised (1:1) to receive either the gaming intervention plus treatment as usual (TAU) or TAU alone. The primary outcome will be the change in social functioning, measured at 3- and 6-month follow-ups. The secondary outcomes will include the patients' major psychiatric symptoms, self-efficacy, quality of life, and aggression and potential adverse effects, also measured at 3 and 6 months. We will also test the feasibility of the gaming intervention from the perspectives of patients and nursing staff at a 3-month follow-up. Data will be collected from outpatient psychiatric services across Finland. Eligible participants will be between 18 and 60 years old and have a formal diagnosis of a psychotic disorder (F20-F29). We aim to recruit a total of 356 participants (178 for each group). We will estimate the efficacy of the intervention on the primary and secondary outcomes based on the intention-to-treat principle. Feasibility data will be analysed separately.

Discussion: This study will be one of the first trials to address the effectiveness of video gaming on improving functional and clinical outcomes in people with schizophrenia. The study will offer new information to confirm both the benefits and possible disadvantages of using gaming to improve patients' health and well-being as new approaches to patient care in mental health services in Finland are explored. The results may provide insight into treatment for other health conditions in which motivational problems impact health outcomes.

Trial registration: NCT05707689. Registered on 21 January 2023.

Background: Long Covid is a term used to describe a multisystem condition that presents with a myriad of physical and psychological symptoms that continue or develop after acute COVID-19. Long Covid is a significant public health problem because of the nature of the illness, its negative impfact on everyday functioning, and the healthcare inequalities evident in access and experience, notably in terms of ethnicity and socioeconomic status. Evidence in patients hospitalised with their acute infection suggests exercise-based rehabilitation could be helpful to improve exercise tolerance, respiratory symptoms, fatigue, and cognition; however, research is needed to determine whether exercise-based rehabilitation is effective and acceptable for patients with Long Covid who were not hospitalised.

Methods: This mixed-methods study comprises a single-centre, randomised controlled trial to determine whether face-to-face rehabilitation increases exercise capacity compared to usual care alone in non-hospitalised patients with Long Covid, with embedded qualitative components to explore intervention acceptability in the context of healthcare inequalities. Usual care is as defined by the National Institute for Clinical Excellence (NICE) Covid-19 guidance. The rehabilitation intervention will take place twice a week for 6 weeks and will combine symptom-titrated exercise with self-management education. The proposed sample size of 56 for the randomised controlled trial is calculated on the primary outcome of Incremental Shuttle Walking Test (ISWT) distance, with a change of 50metres (m) at 90% power, a standard deviation of 17 m, and a 0.05 type 1 error.

Discussion: A mixed-methods approach has been chosen as quantitative data alone would be insufficient to answer the research question, and mixing the data will enable a more comprehensive understanding and ensure there is an equal focus on outcomes and experiences of a face-to-face exercise-based rehabilitation programme. A healthcare inequalities lens will explore who may be under-represented, with the qualitative work providing further evidence as to why this may be the case. It is recognised that meeting recruitment targets in the context of reducing referral rates and funding for Long Covid services may prove challenging.

Trial registration: ISRCTN trial registry (ISRCTN33340595). Registered on 30 September 2024.

Background: Patient and Public Involvement and Engagement (PPIE) is an essential element of any clinical trial, to ensure that the research design and resources are acceptable and the trial produces findings that are relevant to research participants and service-users. The WILL (When to Induce Labour to Limit risk in pregnancy hypertension) Trial Management Team involved a group of patient and public members to develop an infographic, for service-users and -providers, to communicate the risks of chronic and gestational hypertension at term gestational age.

Methods: Based on national resources in the UK for PPIE, including those from the National Institute for Health and Care Research (NIHR) and Health Research Authority, active trial sites (all in the UK) were approached to invite women with pregnancy hypertension to the PPIE group, and advertisements were placed on the Action on Pre-Eclampsia Charity (APEC) and NIHR People in Research websites. PPIE resources were established by the Trial Management Team and virtual meetings with the PPIE members held to co-design and develop the infographic from existing trial materials, using Microsoft Publisher.

Results: Seven diverse PPIE members were involved, six from NIHR People in Research and one from APEC. No members were engaged from active sites. From initial set-up to REC approval of the infographic took 9 months, and a considerable time commitment from the Trial Manager and Senior Research Midwives, to navigate practicalities (e.g. team consensus-building). Four meetings were held and 15 iterations of the infographic were developed with the group. The infographic incorporated requests from PPIE members for a design that was inclusive of all races, cultures, abilities and genders. Discussions with PPIE group members improved our understanding of the acceptability of the trial intervention to some cultures. The Research Ethics Committee (REC) requested revisions to PPIE-approved wording about the risk of stillbirth, from '1 in 1000' to 'small increased risk' prior to issuing approval for use.

Conclusions: More practical support would be useful for researchers seeking to establish PPIE groups, and RECs reviewing resources that are co-produced. Our case study provides a practical, step-by-step account of establishing a PPIE group without a funded co-lead, highlighting strengths such as the diversity of members, the incorporation of cultural perspectives, and the development of inclusive patient-facing materials. These findings add to PPIE practice by offering operational guidance, lessons learned and a summary checklist as an additional resource that can complement existing high-level frameworks.

Trial registration: ISRCTN77258279, registered on 05 December 2018.

Background: In Denmark, the current treatment of patients with symptomatic chronic subdural hematoma (CSDH) is single burr hole hematoma evacuation followed by 24-h passive subdural drainage. However, recent studies indicate that 24-h active subperiosteal drainage may be safer and have fewer recurrences. The upcoming SUPERDURA trial will investigate 24-h active subperiosteal drainage versus 24-h passive subdural drainage following single burr-hole evacuation of symptomatic CSDH. This study presents the statistical analysis plan for the SUPERDURA trial.

Methods: SUPERDURA is a national multi-center non-inferiority randomized clinical trial. The primary outcome is a composite of 90-day mortality and ipsilateral recurrent CSDH requiring reoperation within the 90-day observation period. Secondary outcomes are 90-day simplified modified Rankin Scale questionnaire (smRSq) score, complications related to surgery, postoperative serious adverse events during the admission and at 90 days, and length of hospitalization. Exploratory outcomes are smRSq score as an ordinal outcome, each component of the primary outcome, and discharge destination. A total of 354 participants must be included (177 in each intervention group) in the study to achieve a stable power > 90% with an alpha of 5% for non-inferiority testing of the primary composite outcome with a margin at 7% absolute risk increase. The allocation sequence and block sizes are blinded to the investigators. Interim analyses for safety and efficacy/futility will be performed after follow-up is completed for 120 and 240 participants, respectively. A Data Safety Monitoring Committee charter has been created following published recommendations. Final analysis will be done by two statisticians blinded to the intervention, creating two abstracts that are unblinded once approved by the study steering committee.

Discussion: The proposed analysis plan is designed in accordance with current guidelines, has clinically important primary and secondary outcomes, and was submitted before the inclusion of the first participant in the SUPERDURA trial to limit bias and increase study transparency and reproducibility.

Trial registration: ClinicalTrials.gov identifier NCT06621407.