Trials最新文献

{"title":"Safety outcome trials in four mainline medical journals 30 years apart: a narrative review and the need for the transparency of informed consents.","authors":"Sinem Nihal Esatoglu, Ayse Ozdede, Yesim Ozguler, Koray Tascilar, Hasan Yazici","doi":"10.1186/s13063-025-08732-x","DOIUrl":"https://doi.org/10.1186/s13063-025-08732-x","url":null,"abstract":"<p><strong>Background: </strong>It was our impression that safety outcome trials were getting more frequent, raising ethical issues mainly related to patient autonomy. We and others had also proposed this autonomy would be best served if wording of the informed consents would be in the public domain.</p><p><strong>Methods: </strong>Initially two observers and an arbiter tabulated the main aims of randomized controlled trials (RCTs) published in 1990-1991 vs. 2019-2020 as efficacy, safety, or undecided in four mainline medical journals, from the websites. A pragmatic design as well as other salient features was also tabulated. After noting too many trials were categorized as undecided, two additional independent observers and the arbiter did a reassessment.</p><p><strong>Results: </strong>In our reassessment of 889 RCTs, 309 in earlier and 580 in the later time period, 828 (93%) were categorized as efficacy and 47 (5%) as a safety trial. We were undecided in 14 (2%) trials. The proportion of safety outcome trials between the two time periods were similar [14/309 (5%) vs. 33/580 (6%)] while RCTs of any category conducted in the critical care settings notably increased in time [12/309 (4%) vs. 52/580 (9%) OR 2.4; 1.3-4.6]. Death was a primary outcome measure in 0/14 among the earlier and 16/33 (49%) among the later safety outcome trials. Stroke in 9 and myocardial infarction in 8 safety outcome trials were additional primary outcome measures in the same group. There were 2 pragmatic trials in the earlier and 93 in the later period.</p><p><strong>Conclusion: </strong>Although we did not observe a differential increase among the safety outcome trials of all categories, those in critical care settings had significantly increased in time. So did the safety outcome trials with primary outcome measures like death, myocardial infarction, and stroke as well as randomized controlled trials with a pragmatic design. These raise the issue of autonomy related to how clearly the sought-after safety through designing empirical studies primarily to quantitate harm had been worded to the trial participants in plain language. We maintain this issue cannot be adequately addressed unless the informed consent forms, especially for safety outcome trials, are in the public domain.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"28"},"PeriodicalIF":2.0,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143042371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A single-site randomized controlled trial of partner navigation to HCV treatment for people who inject drugs: a study protocol for the You're Empowered for Treatment Initiation (YETI) partner trial.","authors":"Meghan D Morris, Judy Y Tan, Claire C McDonell, Maia Scarpetta, Tiffany N Nguyen, Jennifer C Price, Torsten B Neilands","doi":"10.1186/s13063-024-08662-0","DOIUrl":"10.1186/s13063-024-08662-0","url":null,"abstract":"<p><strong>Background: </strong>Disparities persist in testing and treatment for hepatitis C virus (HCV), leaving socially marginalized populations, including people who inject drugs (PWID), less likely to benefit from curative treatment. Linkage services are often insufficient to overcome barriers to navigating the medical system and contextual factors.</p><p><strong>Methods: </strong>The You're Empowered for Treatment Initiation (YETI) Partner trial is a single-site randomized controlled trial evaluating the efficacy of a two-session behavioral intervention that engages injecting partners as peer navigators for HCV treatment. We aim to recruit 250 PWID and their primary injecting partners in San Francisco, California, randomizing them 1:1 to either a control or intervention group. The primary outcome is the initiation of HCV treatment, with secondary outcomes including treatment completion and sustained virologic response 12 weeks post-treatment. Data will be collected through questionnaires and electronic health records and analyzed using intention-to-treat and mixed-effects models.</p><p><strong>Discussion: </strong>This trial will provide evidence of a new HCV treatment linkage intervention leveraging the support of primary injecting partners to initiate HCV treatment. If successful, the intervention could inform public health strategies and policies to address HCV in marginalized populations.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06179498. Registered on December 22, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"26"},"PeriodicalIF":2.0,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11753105/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024902","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of early versus late artificial rupture of membranes during oxytocin induction of labour on the incidence of chorioamnionitis: a randomised controlled trial (ARM trial).","authors":"Meghan G Hill, Michelle R Wise, Emmanuelle Pauleau, Beatrice Treadwell, Lynn Sadler","doi":"10.1186/s13063-025-08722-z","DOIUrl":"10.1186/s13063-025-08722-z","url":null,"abstract":"<p><strong>Background: </strong>The approach to induction of labour differs internationally, with timing of amniotomy being controversial. Some institutions favour performing artificial rupture of membranes prior to commencement of oxytocin infusion, with the belief that the labour will progress more efficiently. In other institutions, the approach recommended is for oxytocin infusion with intact amniotic membranes until the person has reached the active phase of labour, citing risk of infection with early amniotomy. Current evidence is inconclusive. We are performing a randomised controlled trial assessing whether delaying amniotomy until the active phase of labour can decrease the rate of chorioamnionitis.</p><p><strong>Methods: </strong>This is a randomised controlled trial at a single centre in New Zealand. Pregnant people undergoing induction of labour at ≥ 37 weeks gestational age with intact membranes and a singleton gestation are eligible for the trial. Participants are randomised to 'Early' amniotomy, at the commencement of oxytocin infusion, or to 'Late' amniotomy, when they have reached a cervical dilation of 6 or more centimetres or when they have been receiving oxytocin infusion for 12 h. The primary outcome of the trial is chorioamnionitis. To detect a decrease in chorioamnionitis from 9 to 3% with a power of 80% and a 95% CI, we will require 488 participants in total, randomised in a 1:1 ratio.</p><p><strong>Discussion: </strong>If delaying amniotomy reduces the rate of chorioamnionitis, this is important to inform future practice. Chorioamnionitis entails risk to both the pregnant person and the fetus and is an important contributor to neonatal sepsis, neonatal intensive care unit admission, maternal sepsis, caesarean, wound infection and postoperative infective complications. Conversely, if the rate of chorioamnionitis is not affected by timing of amniotomy, this will allow for safe individualization of care.</p><p><strong>Trial registration: </strong>The trial is registered on the Australian and New Zealand Clinical Trials Registry, anzctr.org.au. Full registry title is 'Impact of early versus late artificial rupture of membranes during oxytocin induction of labour on the incidence of chorioamnionitis: A randomised controlled trial'.</p><p><strong>Trial id: </strong>ACTRN12621000405819. Date registered 14 April 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"27"},"PeriodicalIF":2.0,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11752794/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Developing generic clinical trial animated explainer videos in the UK: results of a survey and case study.","authors":"Clare Calvert, Vicki S Barber, Duncan Appelbe, Kirsty Sprange, Claire Nollett, Fiona Lugg-Widger, Samantha Tanner, Duncan B Richards","doi":"10.1186/s13063-024-08687-5","DOIUrl":"10.1186/s13063-024-08687-5","url":null,"abstract":"<p><strong>Background: </strong>Animated short videos used to explain a concept or project are often called animated explainer videos (AEVs). AEVs can supplement or provide an alternative to participant information sheets as a means of giving information about clinical research to potential participants. Current use of AEVs tends to focus on the specifics of a particular trial, yet there are many common aspects of clinical research regardless of the interventions being investigated that can be poorly covered in current trial materials. The EXPLAIN initiative aimed to determine the top generic clinical trial topics considered most important by different UK trial stakeholders. The top three topics were then turned into AEVs and have been made freely available for use.</p><p><strong>Method: </strong>A list of generic clinical trial topics which often need explaining to potential trial participants when they are approached to take part in research was developed. Using a two-round Delphi survey of stakeholder groups (trial participants, patients, members of the public, site staff and clinical trials unit staff), the list of topics was expanded and prioritised to identify the topics most in need of clear explanation. The top three topics formed the basis of three AEVs, co-developed with patient and public partners.</p><p><strong>Results: </strong>Two hundred twenty-eight responses were received to the first round of the Delphi survey, and 167 of these respondents also completed the second round of the survey. The three topics prioritised for creation of animated explainer videos were as follows: (1) What is consent? (2) Who decides what treatment I get/What is randomisation? (3) Is it safe to take part in a trial/How do you know a trial is safe? Following virtual meetings with patient and public partners recruited from the Delphi respondents, a script for each AEV was co-produced before being developed into an AEV by a company specialising in animated video production.</p><p><strong>Conclusion: </strong>There are a wide range of generic concepts in which the use of animated explainer videos could be useful to improve participant understanding of clinical research. Via consensus survey across multiple stakeholders, we have determined a hierarchy of the importance of explaining these concepts. We envisage that the three AEVs created from this project will form the basis of a readily accessible library of animations to be utilised by trialists.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"25"},"PeriodicalIF":2.0,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11753093/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012350","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Large simple randomized controlled trials-from drugs to medical devices: lessons from recent experience.","authors":"Sergio Buccheri, Stefan James, Marion Mafham, Martin Landray, Tom Melvin, Jonas Oldgren, Richard Bulbulia, Louise Bowman, Lotje Anna Hoogervorst, Perla J Marang-van de Mheen, Peter Juni, Peter McCulloch, Alan G Fraser","doi":"10.1186/s13063-025-08724-x","DOIUrl":"10.1186/s13063-025-08724-x","url":null,"abstract":"<p><p>Randomized controlled trials (RCTs) are the cornerstone of modern evidence-based medicine. They are considered essential to establish definitive evidence of efficacy and safety for new drugs, and whenever possible they should also be the preferred method for investigating new high-risk medical devices. Well-designed studies robustly inform clinical practice guidelines and decision-making, but administrative obstacles have made it increasingly difficult to conduct informative RCTs. The obstacles are compounded for RCTs of high-risk medical devices by extra costs related to the interventional procedure that is needed to implant the device, challenges with willingness to randomize patients throughout a trial, and difficulties in ensuring proper blinding even with sham procedures. One strategy that may help is to promote the wider use of simpler and more streamlined RCTs using data that are collected routinely during healthcare delivery. Recent large simple RCTs have successfully compared the performance of drugs and of high-risk medical devices, against alternative treatments; they enrolled many patients in a short time, limited costs, and improved efficiency, while also achieving major impact. From a task conducted within the CORE-MD project, we report from our combined experience of designing and conducting large pharmaceutical trials during the COVID-19 pandemic, and of planning and coordinating large registry-based RCTs of cardiovascular devices. We summarize the essential principles and utility of large simple RCTs, likely applicable to all interventions but especially in order to promote their wider adoption to evaluate new medical devices.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"24"},"PeriodicalIF":2.0,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749104/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effect of the APOE4 genotype on physiological and cognitive health in randomised controlled trials with an exercise intervention: a systematic review and meta-analysis.","authors":"Felicity S E Spencer, Richard J Elsworthy, Leigh Breen, Jon R B Bishop, Connor Dunleavy, Sarah Aldred","doi":"10.1186/s13063-024-08696-4","DOIUrl":"https://doi.org/10.1186/s13063-024-08696-4","url":null,"abstract":"<p><strong>Background: </strong>Alzheimer's disease is caused by modifiable and non-modifiable risk factors. Randomised controlled trials have investigated whether the strongest genetic risk factor for Alzheimer's disease, APOE4, impacts the effectiveness of exercise on health. Systematic reviews are yet to evaluate the effect of exercise on physical and cognitive outcomes in APOE genotyped participants. A quality assessment of these randomised controlled trials is needed to understand the impact genotype has on the potential success of intervention. This systematic review aimed to determine if the APOE4 genotype influences the effectiveness of exercise-based randomised controlled trials.</p><p><strong>Method: </strong>Searches on MEDLINE, EMBASE, and PsycINFO identified eligible exercise based randomised controlled trials incorporating participants with varied cognitive abilities. Quality assessments were conducted.</p><p><strong>Results: </strong>Nineteen studies met the inclusion criteria for systematic review, and 3 for the meta-analysis. Very low to moderate quality evidence showed that APOE4 carriers benefitted more than APOE4 non-carriers on cognitive (e.g. executive function, learning) and physical (e.g. relative telomere length) outcomes after exercise; and that APOE4 non-carriers benefited over carriers for physical (serum BDNF, gait speed) and cognitive (global cognition, verbal memory) markers. Very low quality evidence indicated that there was no evidence of difference between APOE4 carriers and non-carriers on physical function outcomes in meta-analysis. Several areas of study design and reporting, including maintenance of relative exercise intensity and complete statistical reporting, were identified as needing improvement.</p><p><strong>Discussion: </strong>This systematic review found very limited evidence to suggest that exercise interventions can benefit APOE4 carriers and non-carriers equally, though conclusions were limited by evidence quality. Further randomised controlled trials, stratifying participants by APOE status are required to better understand the relationship between APOE genotype and the effect of exercise on health-related outcomes.</p><p><strong>Trial registration: </strong>This review was registered with PROSPERO (CRD42023436842). Registered on June 16, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"20"},"PeriodicalIF":2.0,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Can a low-threshold check-up motivate older adults to schedule a dental visit? Study protocol for a randomized controlled trial.","authors":"Aster De Vleeschauwer, Louise Poppe, Roos Colman, Barbara Janssens","doi":"10.1186/s13063-025-08728-7","DOIUrl":"10.1186/s13063-025-08728-7","url":null,"abstract":"<p><strong>Background: </strong>Most oral diseases benefit from early detection by dental professionals. However, in the older population, regular dental attendance is low. This trial investigates whether a low-threshold check-up by a dental professional in a non-dental setting can motivate older persons to seek professional oral care.</p><p><strong>Methods: </strong>A total of 194 community-dwelling persons aged 65 years and older, without a dental check-up over the last 12 months, will be recruited for this randomized, controlled, two-arm, single-blinded, superiority trial with a 1:1 allocation ratio. The intervention group will receive an oral examination including tailored oral health information. They will also be informed about the importance of regular dental visits and will be provided with referral letters for the dental professional and the family physician and a list of nearby dentists. In the control group, the oral examination including tailored information will not be performed. This group will only receive flyers with general oral hygiene information and a list of nearby dentists. The primary outcome is whether or not the participants will contact a dental professional within four months after the intervention.</p><p><strong>Discussion: </strong>This study examines the efficacy of a low-threshold dental check-up intervention to motivate older adults to contact a dental professional and reactivate them into primary oral care, addressing barriers to oral care such as low health literacy, subjective treatment need, and dental anxiety. Key strategies include enhancing oral health knowledge, identifying existing oral issues, and involving family physicians. The study, set to run from April 2024 to March 2025, aims to inform future evidence-based oral health promotion strategies for community-dwelling older adults.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06341959. Registered on 25 April 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"23"},"PeriodicalIF":2.0,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11749651/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012404","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A randomized controlled trial comparing immersive virtual reality games versus nitrous oxide for pain reduction in common outpatient procedures in pediatric surgery.","authors":"Cordula Scherer, Ladina A Lanz, Thoralf R Liebs, Nadine Kaiser, Mirjam Zindel, Steffen M Berger","doi":"10.1186/s13063-025-08718-9","DOIUrl":"10.1186/s13063-025-08718-9","url":null,"abstract":"<p><strong>Background: </strong>Children often experience anxiety and pain during minor surgical procedures, prompting the search for effective pain management strategies beyond traditional pharmaceutical approaches. This study aims to evaluate the efficacy of virtual reality (VR) as a pain reduction method in pediatric outpatient surgical interventions compared to the standard use of nitrous oxide. The research questions explore pain reduction levels, patient preferences, enjoyment during VR use, and the time limit of the VR application.</p><p><strong>Methods: </strong>The study employs a randomized controlled trial design, utilizing VR technology and nitrous oxide in separate groups in 100 children at the age from 6 to 15 undergoing minor surgical procedures. Outcomes are monitored directly after the intervention and two weeks following the procedure. The primary outcome measure is the pain level, assessed using visual face and visual analog scales. Secondary outcomes are the fun and/or fear experienced during the intervention, the willingness to undergo the same procedure again (if necessary), and whether there is a time limit with the VR application compared to nitrous oxide. The study also considers adverse events and safety measures.</p><p><strong>Discussion: </strong>The study aims to address a significant research gap in pediatric pain management strategies, as it is the first randomized controlled trial designed to compare pain levels using VR versus a control group with nitrous oxide analgosedation in children undergoing minor surgical procedures. Preliminary evidence suggests VR may offer a viable alternative to traditional pain management methods, as VR technology could be an effective distraction and pain management tool for pediatric patients undergoing outpatient surgical procedures.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05510141. Registered on August 22, 2022. Virtual Reality Games in Pediatric Surgery-Full Text View-ClinicalTrials.gov.</p><p><strong>Trial sponsor: </strong>The principal investigator, Cordula Scherer act as the Sponsor, Clinic for pediatric surgery, Inselspital, Bern University Hospital, CH 3010 Bern, Switzerland.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"21"},"PeriodicalIF":2.0,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11744987/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of perioperative analgesia in PENG block for children undergoing hip surgery with developmental dysplasia: study protocol for a randomized, double-blinded, non-inferiority trial.","authors":"Mingzhe Xu, Yi He, Zhi Li, Bin Du","doi":"10.1186/s13063-025-08725-w","DOIUrl":"https://doi.org/10.1186/s13063-025-08725-w","url":null,"abstract":"<p><strong>Background: </strong>Surgical intervention is critical in the treatment of hip developmental dysplasia in children. Perioperative analgesia, usually based on high opioid dosages, is frequently used in these patients. In some circumstances, regional anesthetic procedures such as caudal block and lumbar plexus block have also been used. Previous research has shown that pericapsular nerve group (PENG) block provides excellent anesthetic efficacy during open hip surgery in adults. PENG block is thought to provide a similar analgesia effect comparable to caudal block.</p><p><strong>Methods: </strong>This study is a single-center, prospective, randomized, double-blinded, non-inferiority experiment that enrolled children aged 6 months to 7 years who were scheduled for developmental dysplasia hip surgery. Following general anesthesia and regional blocks (0.25% ropivacaine at a dose of 2.5 mg·kg^-1 with epinephrine at a concentration of 1:200,000), 48 individuals will be randomly assigned to either the PENG or caudal groups. The primary outcome measure is the highest FLACC (face, legs, activity, crying, consolability) score achieved within 24 h of surgery. Secondary outcomes include intraoperative opioid consumption, analgesic dosage within 24 h of surgery, time to start rescue analgesia, number of PCA pump activations, time to remove SLIPA (streamlined liner of the pharynx airway), duration of regional block procedures, incidence of adverse events, plasma ropivacaine concentrations, and hospital stays and costs. All data will be collected by blinded investigators. The trial's final results will be published in a peer-reviewed scientific journal.</p><p><strong>Discussion: </strong>We expect this trial to provide some evidences that PENG block is safe and effective for perioperative analgesia in pediatric patients undergoing open hip surgery.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2100053128. Registered on November 12, 2021.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"19"},"PeriodicalIF":2.0,"publicationDate":"2025-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11742540/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of breathing exercises on urinary symptoms, muscle activity, and strength in women with multiple sclerosis and urinary incontinence-a study protocol for a randomized controlled trial study.","authors":"Atieh Nazem, Shabnam ShahAli, Mehdi Dadgoo, Holakoo Mohsenifar, Ismail Ebrahimi Takamjani, Laleh Abadi Marand","doi":"10.1186/s13063-025-08721-0","DOIUrl":"https://doi.org/10.1186/s13063-025-08721-0","url":null,"abstract":"<p><strong>Background: </strong>Urinary incontinence (UI) is a common and debilitating condition among people with multiple sclerosis (MS) and is more prevalent among women. Over the past decade, numerous studies have investigated the effects of pelvic floor muscle training (PFMT) as a treatment for UI in people with MS. MS negatively impacts pulmonary function even in the early stages of the disease and people with MS may experience respiratory muscle weakness. Considering the synergy between the pelvic floor muscle (PFM) and respiratory muscles, this trial will evaluate the effects of PFMT and breathing exercises on PFM activity and strength, diaphragm activity, and urinary symptoms in women with MS who experience UI.</p><p><strong>Methods: </strong>Fifty women with MS and UI will participate in this parallel randomized controlled trial, comprising 32 treatment sessions. The intervention group consists of PFMT and breathing exercises, and the control group includes PFMT. The severity of UI symptoms, PFM activity, diaphragm activity, and PFM strength will be evaluated using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, ultrasound imaging, and modified Oxford grading scale, respectively before and after the intervention.</p><p><strong>Discussion: </strong>The current trial is designed to examine the effects of a combined exercise program for UI in women with MS. It is hypothesized that using breathing exercises in conjunction with PFM exercises will improve patient symptoms compared to PFMT alone.</p><p><strong>Trial registration: </strong>The trial was registered in the Iranian Registry of Clinical Trials with code IRCT20180916041051N3 and was approved on 23 May 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"18"},"PeriodicalIF":2.0,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11740495/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143012353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}