Pub Date : 2026-01-27DOI: 10.1186/s13063-026-09472-2
Martin Bystad, Sveinung Rydland, Christian Bugge, Sissel Høgmo, Birgit Brøndbo, Renate Jacobsen, Lorena García-Fernández, Roberto Rodríguez-Jiménez, Verónica Romero-Ferreiro, Rolf Wynn
Background: This protocol was developed to describe the design of a randomised controlled trial that will examine the clinical efficacy of a 4-week comparison of high-intensity vs. low-intensity physical training for people suffering from anxiety. The hypothesis is that the high-intensity group will have greater benefit in terms of reduced anxiety symptoms, improved physical health (blood pressure) and better adherence.
Methods: Thirty adults aged 18 to 70 years diagnosed with an anxiety disorder will be recruited for this study. Participants will be randomised into an intervention group (high-intensity training) and a control group (low-intensity training). Randomisation will be performed using counterbalanced block randomisation in a 1:1 ratio, stratified by sex. Both groups will perform 4 weeks of twice-weekly training supervised by an exercise physiologist. The primary outcome will be the total score on the Hospital Anxiety and Depression Scale (HADS) and the total score on the Beck Anxiety Inventory (BAI). The secondary outcomes include blood-pressure changes and adherence. Evaluations will be performed at baseline and following 4 weeks of the interventions, and 6 months after the termination of the intervention period (secondary endpoint).
Discussion: By investigating the clinical efficacy of a 4-week training intervention, we hope to provide applicable and generalisable knowledge about the efficacy of physical training for people suffering from anxiety disorders.
Trial registration: Clinical Trials NCT06881758 . Registered on 17 March 2025.
{"title":"High-intensity training vs. low-intensity training for patients with anxiety: a randomised controlled trial.","authors":"Martin Bystad, Sveinung Rydland, Christian Bugge, Sissel Høgmo, Birgit Brøndbo, Renate Jacobsen, Lorena García-Fernández, Roberto Rodríguez-Jiménez, Verónica Romero-Ferreiro, Rolf Wynn","doi":"10.1186/s13063-026-09472-2","DOIUrl":"10.1186/s13063-026-09472-2","url":null,"abstract":"<p><strong>Background: </strong>This protocol was developed to describe the design of a randomised controlled trial that will examine the clinical efficacy of a 4-week comparison of high-intensity vs. low-intensity physical training for people suffering from anxiety. The hypothesis is that the high-intensity group will have greater benefit in terms of reduced anxiety symptoms, improved physical health (blood pressure) and better adherence.</p><p><strong>Methods: </strong>Thirty adults aged 18 to 70 years diagnosed with an anxiety disorder will be recruited for this study. Participants will be randomised into an intervention group (high-intensity training) and a control group (low-intensity training). Randomisation will be performed using counterbalanced block randomisation in a 1:1 ratio, stratified by sex. Both groups will perform 4 weeks of twice-weekly training supervised by an exercise physiologist. The primary outcome will be the total score on the Hospital Anxiety and Depression Scale (HADS) and the total score on the Beck Anxiety Inventory (BAI). The secondary outcomes include blood-pressure changes and adherence. Evaluations will be performed at baseline and following 4 weeks of the interventions, and 6 months after the termination of the intervention period (secondary endpoint).</p><p><strong>Discussion: </strong>By investigating the clinical efficacy of a 4-week training intervention, we hope to provide applicable and generalisable knowledge about the efficacy of physical training for people suffering from anxiety disorders.</p><p><strong>Trial registration: </strong>Clinical Trials NCT06881758 . Registered on 17 March 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":"153"},"PeriodicalIF":2.0,"publicationDate":"2026-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146066851","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}
Pub Date : 2026-01-27DOI: 10.1186/s13063-025-09349-w
Bingjie Li, Ke Peng, Ke Xu, Xiaoying Liu, Chenxi Lu, Yu Shi, Guiyuan Han, Liang Wang, Xianrui Chen, Zule Ning, Yichong Li
Background: Cardiovascular and cerebrovascular diseases are the leading causes of death in the Chinese population, and hypertension is one of the key risk factors. However, the blood pressure control rate of hypertensive patients is low at present. The main factors include the limited capacity of primary care workers and poor self-management among hypertensives. The purpose of this program is to use a clinical decision support system (CDSS) and an Internet of Things-based comprehensive hypertension management system (CATCH) to provide decision support for the diagnosis and treatment of hypertension for primary care clinicians and to improve the standardisation of the diagnosis, monitoring, treatment, and continuous management of hypertension among them.
Methods: This study is a stepped wedge cluster randomised controlled trial conducted in 12 community health centres in the Third People's Hospital of Longgang District, Shenzhen City, China. All participants who are registered in the community and with systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg at the screening clinic will be asked to participate in the study. The intervention is a CATCH composite of a hypertension auxiliary decision-making module, clinical diagnosis and treatment knowledge education system, and quality control system. All 12 clusters will be divided into 4 clusters and 5 stages according to a randomised method, with each stage lasting 3 months, ensuring that the entire trial will be completed within 12 months.
Discussion: The CATCH trial uses CDSS and IoT to improve hypertension management in primary care. This stepped wedge trial enhances guideline adherence and patient outcomes through remote monitoring and quality control. All centres receive the intervention, ensuring equitable access to it. Results will guide future hypertension strategies.
Trial registration: The trial was registered at the National Medical Research Registration and Record Filing Information System of China in December 2024, was retrospectively registered at the Chinese Clinical Trial Registry (ChiCTR) (Registration number: ChiCTR2500098845) https://www.chictr.org.cn/.
{"title":"Effectiveness of a CDSS and Internet of Things-based comprehensive hypertension management system in primary health care settings: study protocol for the CATCH Trial.","authors":"Bingjie Li, Ke Peng, Ke Xu, Xiaoying Liu, Chenxi Lu, Yu Shi, Guiyuan Han, Liang Wang, Xianrui Chen, Zule Ning, Yichong Li","doi":"10.1186/s13063-025-09349-w","DOIUrl":"10.1186/s13063-025-09349-w","url":null,"abstract":"<p><strong>Background: </strong>Cardiovascular and cerebrovascular diseases are the leading causes of death in the Chinese population, and hypertension is one of the key risk factors. However, the blood pressure control rate of hypertensive patients is low at present. The main factors include the limited capacity of primary care workers and poor self-management among hypertensives. The purpose of this program is to use a clinical decision support system (CDSS) and an Internet of Things-based comprehensive hypertension management system (CATCH) to provide decision support for the diagnosis and treatment of hypertension for primary care clinicians and to improve the standardisation of the diagnosis, monitoring, treatment, and continuous management of hypertension among them.</p><p><strong>Methods: </strong>This study is a stepped wedge cluster randomised controlled trial conducted in 12 community health centres in the Third People's Hospital of Longgang District, Shenzhen City, China. All participants who are registered in the community and with systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg at the screening clinic will be asked to participate in the study. The intervention is a CATCH composite of a hypertension auxiliary decision-making module, clinical diagnosis and treatment knowledge education system, and quality control system. All 12 clusters will be divided into 4 clusters and 5 stages according to a randomised method, with each stage lasting 3 months, ensuring that the entire trial will be completed within 12 months.</p><p><strong>Discussion: </strong>The CATCH trial uses CDSS and IoT to improve hypertension management in primary care. This stepped wedge trial enhances guideline adherence and patient outcomes through remote monitoring and quality control. All centres receive the intervention, ensuring equitable access to it. Results will guide future hypertension strategies.</p><p><strong>Trial registration: </strong>The trial was registered at the National Medical Research Registration and Record Filing Information System of China in December 2024, was retrospectively registered at the Chinese Clinical Trial Registry (ChiCTR) (Registration number: ChiCTR2500098845) https://www.chictr.org.cn/.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":"152"},"PeriodicalIF":2.0,"publicationDate":"2026-01-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146053832","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}
Pub Date : 2026-01-26DOI: 10.1186/s13063-026-09492-y
Edward H Brown, Nicholas C Peiper, Stephen Furmanek, Kelly C McCants
<p><strong>Background: </strong>Underrepresentation of racial and ethnic minorities, women, and certain age groups in clinical trials continues to threaten the validity of novel therapeutic interventions and exacerbate longstanding inequities in health outcomes. Despite attention and mandates across institutions and federal agencies to address these disparities, effective and actionable strategies have remained a subject of debate in the existing literature. This study provides preliminary findings from the Advancing Research Through Inclusivity, Sustainability, and Equity (ARISE) Program, a quality improvement initiative to improve representation of racial and ethnic minorities and other underrepresented populations (e.g., women, certain age groups) in clinical trials conducted in an urban hospital system. The primary objective of this study was to examine the racial and ethnic distribution of research participants enrolled in drug and device clinical trials from 2017 to 2024. The secondary objective was to integrate electronic health records and local census data to create benchmarks for comparative purposes.</p><p><strong>Methods: </strong>This study employed a successive-independent samples design to characterize the demographic distribution of 1767 adult research participants enrolled in a drug or device clinical trial from 2017 to 2024. Demographic data were integrated from electronic health records and summarized overall and by year. The z-test for independent proportions was used to compare the research participant demographics to the overall patient population (N = 2,062,865) and local census (N = 608,210). Effect size estimates were calculated using Cohen's h to determine practically significant differences between research participants, the overall patient population, and local census.</p><p><strong>Results: </strong>Research participants were more likely than the patient population to represent older age groups (55-74 years) and White race (83.1% vs 73.1%) but were comparable in terms of ethnicity and biological sex. When compared to local census data, research participants were more likely to represent older age groups, while increases in White participants and decreases in Black participants were observed. There were increases in the proportions of Black and female participants from 2017 to 2024, while White participation decreased. The proportion of Hispanic research participation fluctuated from 2017 to 2024 but remained below census and patient population levels (4.7% and 5.3%, respectively).</p><p><strong>Conclusions: </strong>The findings from this study will directly inform future strategies of the ARISE Program for setting enrollment goals and creating recruitment metrics that facilitate increased representation of racial and ethnic minorities and other health disparity populations in clinical trials. Future studies should integrate primary and secondary data to take into consideration the eligibility criteria from clinical t
{"title":"Integrating clinical trial data with electronic health records to improve diversity in research: findings from an urban hospital system.","authors":"Edward H Brown, Nicholas C Peiper, Stephen Furmanek, Kelly C McCants","doi":"10.1186/s13063-026-09492-y","DOIUrl":"10.1186/s13063-026-09492-y","url":null,"abstract":"<p><strong>Background: </strong>Underrepresentation of racial and ethnic minorities, women, and certain age groups in clinical trials continues to threaten the validity of novel therapeutic interventions and exacerbate longstanding inequities in health outcomes. Despite attention and mandates across institutions and federal agencies to address these disparities, effective and actionable strategies have remained a subject of debate in the existing literature. This study provides preliminary findings from the Advancing Research Through Inclusivity, Sustainability, and Equity (ARISE) Program, a quality improvement initiative to improve representation of racial and ethnic minorities and other underrepresented populations (e.g., women, certain age groups) in clinical trials conducted in an urban hospital system. The primary objective of this study was to examine the racial and ethnic distribution of research participants enrolled in drug and device clinical trials from 2017 to 2024. The secondary objective was to integrate electronic health records and local census data to create benchmarks for comparative purposes.</p><p><strong>Methods: </strong>This study employed a successive-independent samples design to characterize the demographic distribution of 1767 adult research participants enrolled in a drug or device clinical trial from 2017 to 2024. Demographic data were integrated from electronic health records and summarized overall and by year. The z-test for independent proportions was used to compare the research participant demographics to the overall patient population (N = 2,062,865) and local census (N = 608,210). Effect size estimates were calculated using Cohen's h to determine practically significant differences between research participants, the overall patient population, and local census.</p><p><strong>Results: </strong>Research participants were more likely than the patient population to represent older age groups (55-74 years) and White race (83.1% vs 73.1%) but were comparable in terms of ethnicity and biological sex. When compared to local census data, research participants were more likely to represent older age groups, while increases in White participants and decreases in Black participants were observed. There were increases in the proportions of Black and female participants from 2017 to 2024, while White participation decreased. The proportion of Hispanic research participation fluctuated from 2017 to 2024 but remained below census and patient population levels (4.7% and 5.3%, respectively).</p><p><strong>Conclusions: </strong>The findings from this study will directly inform future strategies of the ARISE Program for setting enrollment goals and creating recruitment metrics that facilitate increased representation of racial and ethnic minorities and other health disparity populations in clinical trials. Future studies should integrate primary and secondary data to take into consideration the eligibility criteria from clinical t","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":"148"},"PeriodicalIF":2.0,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146047195","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}
Pub Date : 2026-01-26DOI: 10.1186/s13063-025-09406-4
Léa Clabeau, Virginie Moulier, Bastien Kaczmarek, Marine Dalmont, Jean-Marie Batail, Noomane Bouaziz, Jérôme Brunelin, Benjamin Calvet, Christophe Daudet, Sonia Dollfus, Philippe Domenech, Dominique Drapier, Filipe Galvao, Bénédicte Gohier, Ghina Harika-Germaneau, Jérôme Holtzmann, Nemat Jaafari, Isabelle Jalenques, Dominique Januel, François Kazour, Andrew Laurin, Florian Letourneur, Arnaud Pouchon, Ludovic Samalin, Anne Sauvaget, David Szekely, Fabien Vinckier, Camille Le Clezio, Vincent Compere, Emmanuel Gérardin, Olivier Guillin, Pierre Quesada, Maud Rothärmel
Background: Major depressive disorder is a leading cause of disability worldwide, with treatment-resistant depression (TRD) affecting approximately one-third of patients and leading to increased morbidity and healthcare costs. Electroconvulsive therapy (ECT) remains a key treatment for TRD, but its efficacy is limited, and it is associated with cognitive side effects and delayed symptom relief. Repetitive transcranial magnetic stimulation (rTMS) shares action mechanisms with ECT and has shown potential in enhancing ECT efficacy in a previous trial. The STIMAGNECT 2 trial aims to evaluate whether an rTMS add-on protocol can improve ECT outcomes in TRD patients after 10 ECT sessions.
Methods: Eighty patients with TRD will be enrolled in a prospective multicentric double-blind randomized controlled trial. All patients will receive a total of 10 ECT sessions. Patients will be randomly assigned to an active or sham rTMS arm. The rTMS protocol (either active or sham) consists of 5 rTMS sessions over 4 days before the beginning of the ECT protocol, with an additional rTMS session the day before each ECT session from the 6th ECT session onward. The main outcome is the response rate following 10 ECT sessions, defined as the proportion of patients achieving a ≥ 50% reduction in their Hamilton Depression Rating Scale (HAMD, 21 items). Secondary outcomes include changes in depression severity (HAMD and QIDS-SR-16) at baseline, during the protocol (Day 4, Day 19, Day 26) and at the end of the protocol, as well as assessment of side effects (adapted UKU), cognitive function (memory, attention, visuospatial abilities, subjective cognitive complaint), autobiographical memory (TEMPau), and ECT session parameters such as seizure characteristics and anesthetic doses. Additionally, potential changes in regional gray matter density, cortical thickness, brain connectivity, and GABA levels will be compared between groups using several magnetic resonance imaging (MRI) sequences (3D, resting-state functional MRI, magnetic resonance spectroscopy).
Discussion: The aim of this trial is to optimize neurostimulation protocols using the synergistic effects of rTMS and ECT in order to improve the treatment of TRD.
Trial registration: ClinicalTrials.gov NCT06391723 Id RCB: 2023-A01813-42. The trial was registered on January 30, 2024.
背景：重度抑郁症是世界范围内致残的主要原因，难治性抑郁症（TRD）影响了大约三分之一的患者，并导致发病率和医疗费用增加。电惊厥治疗（ECT）仍然是治疗TRD的关键方法，但其疗效有限，并且与认知副作用和症状缓解延迟有关。重复经颅磁刺激（rTMS）与ECT有相同的作用机制，并在先前的试验中显示出增强ECT疗效的潜力。STIMAGNECT 2试验旨在评估rTMS附加方案是否可以改善10次ECT治疗后TRD患者的ECT结果。方法：80例TRD患者将被纳入一项前瞻性多中心双盲随机对照试验。所有患者总共将接受10次电痉挛治疗。患者将被随机分配到活动或假rTMS组。rTMS协议（活动或假）包括在ECT协议开始前4天内的5次rTMS会话，从第6次ECT会话开始的每个ECT会话的前一天额外的rTMS会话。主要结果是10次ECT治疗后的反应率，定义为汉密尔顿抑郁评定量表（HAMD， 21项）降低≥50%的患者比例。次要结局包括基线时、治疗过程中（第4天、第19天、第26天）和治疗结束时抑郁严重程度（HAMD和QIDS-SR-16）的变化，以及副作用（适应性UKU）、认知功能（记忆、注意力、视觉空间能力、主观认知主体性主体性主体性主体性认知主体性）、自传记忆（TEMPau）和ECT治疗参数（如癫痫发作特征和麻醉剂量）的评估。此外，还将利用磁共振成像（MRI）序列（3D、静息状态功能MRI、磁共振波谱）比较两组间区域灰质密度、皮质厚度、大脑连通性和GABA水平的潜在变化。讨论：本试验的目的是利用rTMS和ECT的协同效应来优化神经刺激方案，以改善TRD的治疗。试验注册：ClinicalTrials.gov NCT06391723 Id RCB: 2023-A01813-42。该试验于2024年1月30日登记。
{"title":"A prospective multicentre double-blind randomized controlled trial evaluating clinical, cognitive and neural effects of potentiation of electroconvulsive therapy by repetitive transcranial magnetic stimulation in patients with treatment-resistant depression (STIMAGNECT 2).","authors":"Léa Clabeau, Virginie Moulier, Bastien Kaczmarek, Marine Dalmont, Jean-Marie Batail, Noomane Bouaziz, Jérôme Brunelin, Benjamin Calvet, Christophe Daudet, Sonia Dollfus, Philippe Domenech, Dominique Drapier, Filipe Galvao, Bénédicte Gohier, Ghina Harika-Germaneau, Jérôme Holtzmann, Nemat Jaafari, Isabelle Jalenques, Dominique Januel, François Kazour, Andrew Laurin, Florian Letourneur, Arnaud Pouchon, Ludovic Samalin, Anne Sauvaget, David Szekely, Fabien Vinckier, Camille Le Clezio, Vincent Compere, Emmanuel Gérardin, Olivier Guillin, Pierre Quesada, Maud Rothärmel","doi":"10.1186/s13063-025-09406-4","DOIUrl":"10.1186/s13063-025-09406-4","url":null,"abstract":"<p><strong>Background: </strong>Major depressive disorder is a leading cause of disability worldwide, with treatment-resistant depression (TRD) affecting approximately one-third of patients and leading to increased morbidity and healthcare costs. Electroconvulsive therapy (ECT) remains a key treatment for TRD, but its efficacy is limited, and it is associated with cognitive side effects and delayed symptom relief. Repetitive transcranial magnetic stimulation (rTMS) shares action mechanisms with ECT and has shown potential in enhancing ECT efficacy in a previous trial. The STIMAGNECT 2 trial aims to evaluate whether an rTMS add-on protocol can improve ECT outcomes in TRD patients after 10 ECT sessions.</p><p><strong>Methods: </strong>Eighty patients with TRD will be enrolled in a prospective multicentric double-blind randomized controlled trial. All patients will receive a total of 10 ECT sessions. Patients will be randomly assigned to an active or sham rTMS arm. The rTMS protocol (either active or sham) consists of 5 rTMS sessions over 4 days before the beginning of the ECT protocol, with an additional rTMS session the day before each ECT session from the 6th ECT session onward. The main outcome is the response rate following 10 ECT sessions, defined as the proportion of patients achieving a ≥ 50% reduction in their Hamilton Depression Rating Scale (HAMD, 21 items). Secondary outcomes include changes in depression severity (HAMD and QIDS-SR-16) at baseline, during the protocol (Day 4, Day 19, Day 26) and at the end of the protocol, as well as assessment of side effects (adapted UKU), cognitive function (memory, attention, visuospatial abilities, subjective cognitive complaint), autobiographical memory (TEMPau), and ECT session parameters such as seizure characteristics and anesthetic doses. Additionally, potential changes in regional gray matter density, cortical thickness, brain connectivity, and GABA levels will be compared between groups using several magnetic resonance imaging (MRI) sequences (3D, resting-state functional MRI, magnetic resonance spectroscopy).</p><p><strong>Discussion: </strong>The aim of this trial is to optimize neurostimulation protocols using the synergistic effects of rTMS and ECT in order to improve the treatment of TRD.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06391723 Id RCB: 2023-A01813-42. The trial was registered on January 30, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":"149"},"PeriodicalIF":2.0,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146047213","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}
Pub Date : 2026-01-26DOI: 10.1186/s13063-026-09484-y
Qianqian Cao, Jin Han, Dongmei Tang, Rongqing Li, Jinxia Jiang, Li Zeng
Background: The high incidence of consciousness disturbance in patients with traumatic brain injury has become a public health and economic concern. Therefore, implementing effective rehabilitation to facilitate awakening in patients with disorders of consciousness is essential. Sensory stimulation, recognized as safe, effective, and affordable, is gaining attention for awakening patients. Additionally, involving family in sensory stimulation is believed to enhance consciousness levels in TBI patients with disorders of consciousness. Thus, we propose a multi-center randomized study to assess the effectiveness of sensory stimulation with family involvement in improving consciousness in TBI patients.
Methods: A multi-center randomized controlled trial with a 3-month follow-up is set in Shanghai and Taicang, Jiangsu, China. Control group participants will receive standard neurosurgical care, whereas the intervention group will get standard care plus a family-involved sensory stimulation program covering vision, hearing, touch, taste, smell, body position, and emotional inputs. The primary outcome is the patient's consciousness level, evaluated using the Glasgow Coma Scale (GCS). The secondary outcomes include the patient's consciousness level (assessed by the Coma Recovery Scale-Revised and the Full Outline of Unresponsiveness score) and the occurrence of complications in patients. Data were collected at baseline (T0) and at 1 week (T1), 1 month (T2), 2 months (T3), and 3 months (T4) from baseline.
Ethics and dissemination: The research protocol was approved by the Ethics Committee of Tongji Hospital of Tongji University, prior to commencement. Informed consent will be obtained from the immediate family members of all participants, as they lack decision-making capacity.
Trials registration: This study was approved by the Ethics Committee of Tongji Hospital of Tongji University (approval number: MR-31-23-050769). And we completed the registration in the Chinese Clinical Trial Registry (approval number: ChiCTR2400080063).
{"title":"Effect of family participation in sensory stimulation for patients with disorders of consciousness after traumatic brain injury prognosis: randomized controlled trial protocol.","authors":"Qianqian Cao, Jin Han, Dongmei Tang, Rongqing Li, Jinxia Jiang, Li Zeng","doi":"10.1186/s13063-026-09484-y","DOIUrl":"10.1186/s13063-026-09484-y","url":null,"abstract":"<p><strong>Background: </strong>The high incidence of consciousness disturbance in patients with traumatic brain injury has become a public health and economic concern. Therefore, implementing effective rehabilitation to facilitate awakening in patients with disorders of consciousness is essential. Sensory stimulation, recognized as safe, effective, and affordable, is gaining attention for awakening patients. Additionally, involving family in sensory stimulation is believed to enhance consciousness levels in TBI patients with disorders of consciousness. Thus, we propose a multi-center randomized study to assess the effectiveness of sensory stimulation with family involvement in improving consciousness in TBI patients.</p><p><strong>Methods: </strong>A multi-center randomized controlled trial with a 3-month follow-up is set in Shanghai and Taicang, Jiangsu, China. Control group participants will receive standard neurosurgical care, whereas the intervention group will get standard care plus a family-involved sensory stimulation program covering vision, hearing, touch, taste, smell, body position, and emotional inputs. The primary outcome is the patient's consciousness level, evaluated using the Glasgow Coma Scale (GCS). The secondary outcomes include the patient's consciousness level (assessed by the Coma Recovery Scale-Revised and the Full Outline of Unresponsiveness score) and the occurrence of complications in patients. Data were collected at baseline (T0) and at 1 week (T1), 1 month (T2), 2 months (T3), and 3 months (T4) from baseline.</p><p><strong>Ethics and dissemination: </strong>The research protocol was approved by the Ethics Committee of Tongji Hospital of Tongji University, prior to commencement. Informed consent will be obtained from the immediate family members of all participants, as they lack decision-making capacity.</p><p><strong>Trials registration: </strong>This study was approved by the Ethics Committee of Tongji Hospital of Tongji University (approval number: MR-31-23-050769). And we completed the registration in the Chinese Clinical Trial Registry (approval number: ChiCTR2400080063).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":"144"},"PeriodicalIF":2.0,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146053738","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}
Pub Date : 2026-01-26DOI: 10.1186/s13063-026-09462-4
Juan Yao, Fangming Shen, Yajing Chen, Wenlan Cai, Xinjian Lu, Zhen Wang, Bin Li, Jue Xie, Xiaoxiang Tan, Jie Sun
<p><strong>Background: </strong>Median sternotomy As per our journal style, article titles should not include capitalised letters unless these are proper nouns/acronyms. We have therefore used the article title "Ultrasound-guided Pecto-intercostal fascial plane block for chronic postoperative pain after cardiac surgery via median sternotomy: study protocol for a randomized controlled trial" as opposed to "Ultrasound-guided Pecto-intercostal Fascial Plane Block for Chronic Postoperative Pain after Cardiac Surgery via Median Sternotomy: study protocol for a randomized controlled trial". Please check if this is correct.remains the preferred incision technique for cardiac surgery. Consequently, postoperative pain is a prevalent complication following such procedures, potentially leading to delayed recovery and a diminished quality of life for patients. The parasternal intercostal fascial plane block (PIFPB) is a superficial regional anesthetic technique targeting the interfacial plane between the pectoralis major and internal intercostal muscles. Currently, no randomized controlled trials have evaluated the impact of PIFPB on chronic pain following cardiac surgery via median sternotomy. To address this knowledge gap, we conducted a prospective, randomized, double-blind, placebo-controlled trial specifically designed to evaluate the effect of preoperative PIFPB on chronic pain incidence in patients undergoing median sternotomy for cardiac surgery.</p><p><strong>Methods: </strong>This study protocol has been approved by the Ethics Review Committee of Zhongda Hospital, Southeast University. We plan to enroll 304 adult patients scheduled for cardiac surgery via median sternotomy under general anesthesia. Participants will be randomly allocated to one of two groups: the PIFPB group will receive a single injection of 40 ml of 0.375% ropivacaine hydrochloride administered, while the control group will receive an equivalent volume of 0.9% saline placebo. The primary outcome is the incidence of chronic pain at 3 months post-surgery.</p><p><strong>Discussion: </strong>This is a novel randomized controlled trial designed to evaluate the impact of preoperative ultrasound-guided single parasternal intercostal fascia plane block on the incidence of chronic post-surgical pain (CPSP) in patients undergoing cardiac surgery via median sternotomy. The study will comprehensively describe the severity of postoperative acute and chronic pain, as well as associated clinical outcomes, in this patient population. Our findings may provide a foundation for optimizing analgesic strategies in cardiac surgery via median thoracotomy, further elucidate the role of regional anesthesia in postoperative chronic pain development, and ultimately improve postoperative quality of life for these patients.</p><p><strong>Trial registration: </strong>The trial protocol was prospectively registered with the China Clinical Trial Registry on June 16, 2025, (trial identifier: ChiCTR2500104378).</
{"title":"Ultrasound-guided pecto-intercostal fascial plane block for chronic postoperative pain after cardiac surgery via median sternotomy: study protocol for a randomized controlled trial.","authors":"Juan Yao, Fangming Shen, Yajing Chen, Wenlan Cai, Xinjian Lu, Zhen Wang, Bin Li, Jue Xie, Xiaoxiang Tan, Jie Sun","doi":"10.1186/s13063-026-09462-4","DOIUrl":"10.1186/s13063-026-09462-4","url":null,"abstract":"<p><strong>Background: </strong>Median sternotomy As per our journal style, article titles should not include capitalised letters unless these are proper nouns/acronyms. We have therefore used the article title \"Ultrasound-guided Pecto-intercostal fascial plane block for chronic postoperative pain after cardiac surgery via median sternotomy: study protocol for a randomized controlled trial\" as opposed to \"Ultrasound-guided Pecto-intercostal Fascial Plane Block for Chronic Postoperative Pain after Cardiac Surgery via Median Sternotomy: study protocol for a randomized controlled trial\". Please check if this is correct.remains the preferred incision technique for cardiac surgery. Consequently, postoperative pain is a prevalent complication following such procedures, potentially leading to delayed recovery and a diminished quality of life for patients. The parasternal intercostal fascial plane block (PIFPB) is a superficial regional anesthetic technique targeting the interfacial plane between the pectoralis major and internal intercostal muscles. Currently, no randomized controlled trials have evaluated the impact of PIFPB on chronic pain following cardiac surgery via median sternotomy. To address this knowledge gap, we conducted a prospective, randomized, double-blind, placebo-controlled trial specifically designed to evaluate the effect of preoperative PIFPB on chronic pain incidence in patients undergoing median sternotomy for cardiac surgery.</p><p><strong>Methods: </strong>This study protocol has been approved by the Ethics Review Committee of Zhongda Hospital, Southeast University. We plan to enroll 304 adult patients scheduled for cardiac surgery via median sternotomy under general anesthesia. Participants will be randomly allocated to one of two groups: the PIFPB group will receive a single injection of 40 ml of 0.375% ropivacaine hydrochloride administered, while the control group will receive an equivalent volume of 0.9% saline placebo. The primary outcome is the incidence of chronic pain at 3 months post-surgery.</p><p><strong>Discussion: </strong>This is a novel randomized controlled trial designed to evaluate the impact of preoperative ultrasound-guided single parasternal intercostal fascia plane block on the incidence of chronic post-surgical pain (CPSP) in patients undergoing cardiac surgery via median sternotomy. The study will comprehensively describe the severity of postoperative acute and chronic pain, as well as associated clinical outcomes, in this patient population. Our findings may provide a foundation for optimizing analgesic strategies in cardiac surgery via median thoracotomy, further elucidate the role of regional anesthesia in postoperative chronic pain development, and ultimately improve postoperative quality of life for these patients.</p><p><strong>Trial registration: </strong>The trial protocol was prospectively registered with the China Clinical Trial Registry on June 16, 2025, (trial identifier: ChiCTR2500104378).</","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":"143"},"PeriodicalIF":2.0,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146053851","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}
Pub Date : 2026-01-26DOI: 10.1186/s13063-026-09435-7
Hui Liu, Hongling Yu, Yerong Yu
{"title":"Commentary on the \"How to improve the quality of euglycemic glucose clamp tests in long‑acting insulin studies\".","authors":"Hui Liu, Hongling Yu, Yerong Yu","doi":"10.1186/s13063-026-09435-7","DOIUrl":"10.1186/s13063-026-09435-7","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":"82"},"PeriodicalIF":2.0,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12833931/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146047202","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}
Background: Peripheral nerve injuries (PNI) commonly result in multiple dysfunctions in clinical practice. Repetitive peripheral magnetic stimulation (rPMS) and repetitive transcranial magnetic stimulation (rTMS) are non-invasive interventions for neuromodulation. Their benefits have been reported respectively in PNI rehabilitation, but little is known about their combined effect. Combined central-peripheral interventions were found to have better improvements than central- or peripheral-only intervention in numerous studies. Hence, we conducted a randomized controlled trial to assess the effect of rPMS combined with rTMS on postoperative median nerve injury (PMNI) and explore its mechanism.
Methods: In this prospective, single-center, randomized clinical trial, we will enroll 60 participants with PMNI and randomize them into four groups (conventional intervention group, rPMS + sham rTMS group, sham rPMS + rTMS group, and rPMS + rTMS group) at a 1:1:1:1 ratio. All participants will undergo interventions for 12 weeks and be assessed at 0, 6, and 12 weeks during the treatment. Measurements will include grip strength, side pinch, Semmes-Weinstein monofilament test (SW), two-point discrimination test (2PD), Purdue pegboard test (PPT), motor conduction velocity test (MCV), and sensory conduction velocity test (SCV). Moreover, functional near-infrared spectroscopy (fNIRS) will be used to explore brain mechanisms. Statistical analysis will be performed using SPSS software with the significance level set at p < 0.05.
Discussion: The results of this study will develop innovative magnetic stimulation techniques for the rehabilitation of PMNI.
Trial registration: This study prospective protocol was approved by the Medical Ethics Committee of Shanghai Jing'an District Central Hospital (ethical approval number 202437, study protocol version 1.0). The trial was prospectively registered at the Chinese Clinical Trial Registry on December 16, 2024, with the name "Effects of Repetitive Transcranial Magnetic Stimulation Combined with Repetitive Peripheral Magnetic Stimulation on Complete Postoperative Median Nerve Injury: Protocol of A Randomized Control Study" (registration number ChiCTR2400094038).
{"title":"Effects of rTMS combined with rPMS on complete postoperative median nerve injury: study protocol for a randomized control study.","authors":"Xianggui Chen, Jiali Lin, Zihang Chen, Yongli Zhang, Zhijie He, Panmo Deng, Shugeng Chen, Jie Jia","doi":"10.1186/s13063-026-09476-y","DOIUrl":"10.1186/s13063-026-09476-y","url":null,"abstract":"<p><strong>Background: </strong>Peripheral nerve injuries (PNI) commonly result in multiple dysfunctions in clinical practice. Repetitive peripheral magnetic stimulation (rPMS) and repetitive transcranial magnetic stimulation (rTMS) are non-invasive interventions for neuromodulation. Their benefits have been reported respectively in PNI rehabilitation, but little is known about their combined effect. Combined central-peripheral interventions were found to have better improvements than central- or peripheral-only intervention in numerous studies. Hence, we conducted a randomized controlled trial to assess the effect of rPMS combined with rTMS on postoperative median nerve injury (PMNI) and explore its mechanism.</p><p><strong>Methods: </strong>In this prospective, single-center, randomized clinical trial, we will enroll 60 participants with PMNI and randomize them into four groups (conventional intervention group, rPMS + sham rTMS group, sham rPMS + rTMS group, and rPMS + rTMS group) at a 1:1:1:1 ratio. All participants will undergo interventions for 12 weeks and be assessed at 0, 6, and 12 weeks during the treatment. Measurements will include grip strength, side pinch, Semmes-Weinstein monofilament test (SW), two-point discrimination test (2PD), Purdue pegboard test (PPT), motor conduction velocity test (MCV), and sensory conduction velocity test (SCV). Moreover, functional near-infrared spectroscopy (fNIRS) will be used to explore brain mechanisms. Statistical analysis will be performed using SPSS software with the significance level set at p < 0.05.</p><p><strong>Discussion: </strong>The results of this study will develop innovative magnetic stimulation techniques for the rehabilitation of PMNI.</p><p><strong>Trial registration: </strong>This study prospective protocol was approved by the Medical Ethics Committee of Shanghai Jing'an District Central Hospital (ethical approval number 202437, study protocol version 1.0). The trial was prospectively registered at the Chinese Clinical Trial Registry on December 16, 2024, with the name \"Effects of Repetitive Transcranial Magnetic Stimulation Combined with Repetitive Peripheral Magnetic Stimulation on Complete Postoperative Median Nerve Injury: Protocol of A Randomized Control Study\" (registration number ChiCTR2400094038).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":"150"},"PeriodicalIF":2.0,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146053843","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}
Background: Prostate cancer is the second most common cancer among men worldwide and is frequently managed with robot-assisted radical prostatectomy (RARP). Standard patient positioning during RARP, specifically the lithotomy and steep Trendelenburg positions with a head-down angle of 25°-45°, can lead to complications such as peripheral nerve injury, elevated intraocular pressure (IOP), dizziness, nausea, and vomiting. This study introduces an alternative "Z-shaped supine position," aimed at reducing postoperative position-related complications and improving patient comfort.
Methods: This single-center, randomized controlled trial will recruit 78 patients scheduled for RARP. Participants will be randomly assigned to either the standard RARP position group or the Z-shaped supine position group. The Z-shaped supine position involves 10°-15° hip flexion, 5°-10° knee flexion, and 20°-30° leg abduction, combined with a 20°-25° Trendelenburg tilt. This position is supported by an integrated shoulder and neck brace. Outcomes include the incidence of peripheral nerve injuries (primary outcome), intraoperative IOP, skin contact pressure, deep vein thrombosis, postoperative pain, and pressure injury. Assessments will be conducted preoperatively, intraoperatively, and postoperatively at multiple time points. Statistical analyses will include an intention-to-treat (ITT) approach and comparisons between the two groups.
Discussion: This study aims to validate the Z-shaped supine position as a safer alternative to standard positioning during RARP, with a focus on reducing perioperative complications while maintaining both functional and surgical outcomes.
Trial registration: Chinese Clinical Trial Registry ChiCTR2300072954. Registered on 28 June, 2023.
{"title":"Efficacy of Z-shaped supine position in robot-assisted radical prostatectomy: study protocol for a randomized controlled trial.","authors":"Yu Yaqian, Zhang Chuanliang, Zeng Guowei, Zhou Xuchuan, Xiao Ming, Hou Yifang","doi":"10.1186/s13063-026-09451-7","DOIUrl":"10.1186/s13063-026-09451-7","url":null,"abstract":"<p><strong>Background: </strong>Prostate cancer is the second most common cancer among men worldwide and is frequently managed with robot-assisted radical prostatectomy (RARP). Standard patient positioning during RARP, specifically the lithotomy and steep Trendelenburg positions with a head-down angle of 25°-45°, can lead to complications such as peripheral nerve injury, elevated intraocular pressure (IOP), dizziness, nausea, and vomiting. This study introduces an alternative \"Z-shaped supine position,\" aimed at reducing postoperative position-related complications and improving patient comfort.</p><p><strong>Methods: </strong>This single-center, randomized controlled trial will recruit 78 patients scheduled for RARP. Participants will be randomly assigned to either the standard RARP position group or the Z-shaped supine position group. The Z-shaped supine position involves 10°-15° hip flexion, 5°-10° knee flexion, and 20°-30° leg abduction, combined with a 20°-25° Trendelenburg tilt. This position is supported by an integrated shoulder and neck brace. Outcomes include the incidence of peripheral nerve injuries (primary outcome), intraoperative IOP, skin contact pressure, deep vein thrombosis, postoperative pain, and pressure injury. Assessments will be conducted preoperatively, intraoperatively, and postoperatively at multiple time points. Statistical analyses will include an intention-to-treat (ITT) approach and comparisons between the two groups.</p><p><strong>Discussion: </strong>This study aims to validate the Z-shaped supine position as a safer alternative to standard positioning during RARP, with a focus on reducing perioperative complications while maintaining both functional and surgical outcomes.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2300072954. Registered on 28 June, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":"147"},"PeriodicalIF":2.0,"publicationDate":"2026-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146053801","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}
Trial Forge Guidance 2 helps trial teams decide if another Study Within A Trial (SWAT) is needed to answer an existing research question. Five criteria are listed to assist decision-making. We are adding a sixth criterion, the Value of Information, to additionally consider the potential time and financial constraints of improving trial process evidence. The Value of Information criterion assesses each trial process based on its value of additional research and value of implementation. We consider evaluations of recruitment and retention strategies as exemplars of how such an approach could be applied to randomised evaluations of trial processes via SWATs. We applied the Value of Information Analysis to all recruitment strategies and categorised them according to their expected benefits in terms of improved recruitment, as well as the level of statistical uncertainty compared to other recruitment strategies. The same approach was followed for retention strategies. To support its use, we have developed an electronic tool that calculates and presents the criterion results for each available evaluation of recruitment and retention strategies. This will enable trial teams to apply the Value of Information criterion, along with the five existing criteria of Trial Forge Guidance 2, when deciding if further SWATs should be prioritised for a particular trial process strategy to provide evidence for the strategy's use, or not during a trial.
{"title":"Update to Trial Forge Guidance 2: addition of the Value of Information criterion.","authors":"Athanasios Gkekas, Adwoa Parker, Shaun Treweek, Elizabeth Coleman, Catherine Arundel, Frances Shiely","doi":"10.1186/s13063-026-09443-7","DOIUrl":"10.1186/s13063-026-09443-7","url":null,"abstract":"<p><p>Trial Forge Guidance 2 helps trial teams decide if another Study Within A Trial (SWAT) is needed to answer an existing research question. Five criteria are listed to assist decision-making. We are adding a sixth criterion, the Value of Information, to additionally consider the potential time and financial constraints of improving trial process evidence. The Value of Information criterion assesses each trial process based on its value of additional research and value of implementation. We consider evaluations of recruitment and retention strategies as exemplars of how such an approach could be applied to randomised evaluations of trial processes via SWATs. We applied the Value of Information Analysis to all recruitment strategies and categorised them according to their expected benefits in terms of improved recruitment, as well as the level of statistical uncertainty compared to other recruitment strategies. The same approach was followed for retention strategies. To support its use, we have developed an electronic tool that calculates and presents the criterion results for each available evaluation of recruitment and retention strategies. This will enable trial teams to apply the Value of Information criterion, along with the five existing criteria of Trial Forge Guidance 2, when deciding if further SWATs should be prioritised for a particular trial process strategy to provide evidence for the strategy's use, or not during a trial.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":"141"},"PeriodicalIF":2.0,"publicationDate":"2026-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12910824/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146041733","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}
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