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Methods for additional analyses (e.g. subgroup analyses) {20b}
stroke, haemorrhagic
STROKE
Subgroup analyses, e.g. based on age (< 65 years, 65–80 years and > 80 years), sex (male and female), stroke severity (NIHSS score; mild, 0–8 moderate, 9–15 and severe, > 15), stroke type (ischaemic vs. haemorrhagic), treatment with tissue plasminogen activator and/or thrombectomy (yes or no) and geographical region, w...
PMC10559468
Methods in analysis to handle protocol nonadherence and any statistical methods to handle missing data {20c}
All analyses will be conducted in accordance with the intention-to-treat principle. Multiple imputation of missing data will be employed in the primary analysis using multiple imputation by chained equation (MICE) [
PMC10559468
Plans to give access to the full protocol, participant-level data and statistical code {31c}
The study protocol, including statistical analyses, will be available in conjunction with the scientific publication. Upon study completion, anonymized data will also be available to the scientific community at large through publications. Moreover, any party may apply to the Chief Investigator for access to the full pr...
PMC10559468
Oversight and monitoring
PMC10559468
Composition of the coordinating centre and trial steering committee {5d}
stroke, TSC
STROKE
The University Hospital of Umeå is the coordinating centre where the Chief Investigator (the first author) and a trial management group (TMG) work. The coordinating centre oversees the fiscal management of the study, ethics approvals, subcontracts with other participating clinics and other financial and oversight respo...
PMC10559468
Composition of the data monitoring committee, its role and reporting structure {21a}
The data monitoring committee (DMC) comprises two RCT process controllers who are independent of the study sponsor and funder. The DMC will monitor clinical trial compliance, the completeness of the study data and data safety twice a year, in accordance with the Standard Operating Procedure (SOPs) and Consolidated Stan...
PMC10559468
Adverse event reporting and harms {22}
TSC
ADVERSE EVENTS, ADVERSE EVENT, EVENTS
Even though they are unlikely in this study, adverse events will be immediately reported to the TSC if classified as Related and Unsuspected Serious Adverse Events (RUSAEs), i.e. events that are unexpected in severity and seriousness and suspected to be related to the study intervention. The TSC will then report the ca...
PMC10559468
Frequency and plans for auditing trial conduct {23}
To increase the fidelity of the study, the DMC members who are independent of the sponsor will regularly (4 times while participating in the study) notify the participating clinics if there is a breach of protocol or GCP principles that is likely to significantly affect participant safety, health and wellbeing as well ...
PMC10559468
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Important protocol amendments will be made by the Chief Investigator following consultation with the TMG and the TSC. All changes to the protocol will be reviewed and approved by the Swedish Ethical Review Authority prior to their implementation. Amendments will then be communicated to research staff and participants b...
PMC10559468
Dissemination plans {31a}
Annual trial meetings will be organized for all unit-allied health professionals for exchanging experiences and spreading knowledge. Monthly newsletters and ongoing e-mail contact will also be used to update the study progress and facilitate communication during the study.Upon completion of the trial, investigators wil...
PMC10559468
Discussion
®, Stroke, ’, stroke, Rehabkompassen®, disability
ADVERSE EFFECTS, STROKE, RECRUITMENT, STROKE
Stroke is a leading cause of disability among adults worldwide, with a heavy burden for patients and their families as well as society [To meet these challenges, Rehabkompassen® was recently created and developed as a novel and unique digital follow-up tool to identify and graphically visualize a panoramic view of stro...
PMC10559468
Trial status
®
The Rehabkompassen® trial is currently being conducted under version 5.0 of the protocol (2023–06-26. We enrolled our first participant on 2022–02-07. The final participant is scheduled to be enrolled in December 2025 and will complete the study by the end of 2026.
PMC10559468
Acknowledgements
Not applicable.
PMC10559468
Authors’ contributions {31b}
XH is the Chief Investigator; she conceived the study, led the proposal and protocol development and wrote the first draft of the protocol. XH, KSS, EL, FN, OL, PL and KB contributed to the study design, development of the proposal and securing trial funding. PL is responsible for the statistical analysis, and FN is re...
PMC10559468
Funding {4}
ALF, Stroke
HEART, LUNG, STROKE
Open access funding provided by Umea University. This study is supported by the Swedish Research Council (Grant for clinical studies within therapy research 2022–00316 and Project funding within medicine and health 2022–00746), Forte (2020–00136), the Heart–Lung Foundation (2020676), Västerbotten County Council and Ume...
PMC10559468
Availability of data and materials {29}
Key study investigators will have access to the final trial dataset. Trial data will be made available to nonstudy investigators following the approval of a study collaboration request by TSC.
PMC10559468
Declarations
PMC10559468
Ethics approval and consent to participate {24}
-20
The proposed research is a multicentre pragmatic clinical study that includes humans and the handling of personal data. The entire study will be carried out in Sweden. Written, informed consent to participate will be obtained from all participants.Ethical approval and completion of the ethical approval for the proposed...
PMC10559468
Consent for publication {32}
Not applicable—no identifying images or other personal or clinical details of participants are presented here or will be presented in reports of the trial results. The participant information materials and informed consent form are available from the corresponding author on request.
PMC10559468
Competing interests {28}
®
As the corresponding author, author XH has created the paper version of the tool Rehabkompassen® and owns the registered trademark Rehabkompassen®. Author XH as the main applicant has obtained several Swedish national grants as stated in the Funding {4} above for the development and assessment of the tool.Together with...
PMC10559468
References
PMC10559468
Background
depression
There is increasing evidence that depression can be prevented; however, universal approaches have had limited success. Appropriate targeting of interventions to at-risk populations has been shown to have potential, but how to selectively determine at-risk individuals remains unclear. Workplace stress is a risk factor f...
PMC10485707
Objective
depression
This trial aimed to evaluate the efficacy of a smartphone-based intervention in reducing the onset of depression and improving related outcomes in workers experiencing at least moderate levels of stress.
PMC10485707
Methods
depression
A randomized controlled trial was conducted with participants who were currently employed and reported no clinically significant depression and at least moderate stress. The intervention group (n=1053) were assigned
PMC10485707
Results
depression caseness
There was no significant between-group difference in new depression caseness (
PMC10485707
Trial Registration
Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000178943; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378592
PMC10485707
Introduction
PMC10485707
Background
depressive disorder, MDD, psychiatric
DISEASE, DISORDERS
Major depressive disorder (MDD) is one of the most common psychiatric disorders worldwide and a leading cause of disease burden [To date, most responses to mental health problems, especially work-based interventions, have been reactive, focusing on individuals who are symptomatic or on sick leave [Determining how to ta...
PMC10485707
Objective
depression
Consequently, we sought to test whether a scalable selective prevention approach to address depression in those affected by workplace stress would be effective. This trial aimed to evaluate the efficacy of a new smartphone app–based intervention in reducing rates of new depression onset, symptomology, and related outco...
PMC10485707
Methods
PMC10485707
Study Design
A randomized controlled trial was conducted nationally in Australia, with 2 parallel arms comparing an app-based prevention intervention (
PMC10485707
Participants
depressed
Participants were required to be aged ≥18 years, currently employed, and an Australian resident. Participants were excluded if they did not own a smartphone or could not understand English. Given the overall aim of this study, it was necessary to recruit a sample of workers who were feeling stressed but not clinically ...
PMC10485707
Procedures
PMC10485707
Overview
RECRUITMENT
Participants were recruited using social media advertisements that ran for 27 days from March 2020 to April 2020. Separate recruitment via industry partners had to be abandoned owing to the COVID-19–related economic restrictions. Individuals who clicked a link on the advertisements were taken to a brief study descripti...
PMC10485707
Ethics Approval
Ethics approval for this study was obtained from the University of New South Wales Human Research Ethics Committee (HC190914).
PMC10485707
Informed Consent and Compensation
Participants provided informed consent after being presented with a web-based participant information statement detailing the aspects of data collection, storage, and use; study procedures; benefits and risks of participation; dissemination of results; confidentiality; and withdrawal of consent. Data were deidentified ...
PMC10485707
Control
The attention-control condition was a health and psychoeducation website (
PMC10485707
Outcome Measures
At baseline, demographic information was collected, including age, sex, occupational position and industry, previous help seeking, and prior experience of poor mental health. All outcome measures were administered at baseline and at 1-, 3-, and 6-month postbaseline time points.
PMC10485707
Primary Outcome
MDD
The primary outcome measure was the incidence of probable MDD aggregated across the follow-up time points. This was measured using the diagnostic algorithm from the PHQ-9 [
PMC10485707
Secondary Outcomes
Depressive, Anxiety, Work-related burnout, depressive symptoms
Depressive symptoms were measured using the PHQ-9 continuous scoring method, with scores ranging from 0 to 27 and cutoff points of 5, 10, 15, and 20 representing mild, moderate, moderately severe, and severe depressive symptoms, respectively [Anxiety symptoms were measured using the General Anxiety Disorder–7 (GAD-7) [...
PMC10485707
Data Analysis and Statistical Power
PMC10485707
Statistical Analyses
Data coding and analyses were carried out by the authors using available software packages including STATA (version 14.2; StataCorp) and SPSS Statistics (version 25.0; IBM Corp). Data on screening, refusals, and dropout were coded and reported according to the CONSORT (Consolidated Standards of Reporting Trials) guidel...
PMC10485707
Sample Size
As a population-based selective prevention intervention, the effect size of the intervention was anticipated to be relatively small. Analysis of previous
PMC10485707
Results
PMC10485707
Primary Outcome—New Depression Caseness
MDD, caseness
REGRESSION
Given the exclusion criteria, no participants met the established PHQ-9 algorithm criteria for a probable diagnosis of MDD at baseline. Mixed effects logistic regression of caseness with postbaseline occasions of measurement and group as crossed factors and a random participant intercept found no overall difference in ...
PMC10485707
Secondary Outcomes
PMC10485707
Other Secondary Outcomes
anxiety
REGRESSION, SECONDARY
There were statistically significant time effects across all time points for most secondary outcomes, showing a regression to the mean. For anxiety symptoms, a significant group-by-time interaction was found at 1-month follow-up (
PMC10485707
App Use
On average, users completed 7.68 (SD 9.26) unique challenges. Although a large portion of the intervention group (518/1053, 49.19%) completed ≤3 challenges, with rates continuing to decline over the full course of the 30-day challenge, 4.84% (51/1053) of the users completed the content in its entirety.Total app use (ch...
PMC10485707
App Feedback
App feedback was received from 468 users: 179 (38.2%) low engagers, 162 (34.6%) medium engagers, and 93 (27.1%) high engagers. The app was well received by respondents, with 81% (379/468) claiming that it had at least moderately improved their mental fitness and only 10.7% (50/468) claiming that they felt no improvemen...
PMC10485707
Discussion
PMC10485707
Principal Findings and Comparison With Prior Work
depression, depressive symptoms
This study evaluated the efficacy of a smartphone app to prevent depression in workers reporting elevated levels of stress. The app did not reduce the incidence of depression, defined as a “case,” but users showed small comparative reductions in depressive symptoms at 1- and 6-month follow-ups. Program adherence was re...
PMC10485707
Limitations
SECONDARY
The findings of this trial are hampered by low rates of app engagement. The issue of engagement is crucial to digital interventions broadly, presenting a barrier to optimal implementation and necessitating further research. Previous work in this area has highlighted a number of elements that might enhance engagement wi...
PMC10485707
Conclusions
Overall, workers experiencing at least moderate levels of stress who had used the This study was supported by funding from the Australian Government Department of Health through the Prevention Hub. SBH, DAJC, and MD were supported by funding from the iCare Foundation and New South Wales Health. SBH was supported by a N...
PMC10485707
Abbreviations
depressive, Anxiety
Assessment of Quality of Life 4-Dimension VersionBrief Resilience ScaleCopenhagen Burnout Inventorycognitive behavioral therapyConsolidated Standards of Reporting TrialsGeneral Anxiety Disorder-7intention-to-treatmajor depressive disorderPatient Health Questionnaire-9Single Item Stress Question5-item World Health Organ...
PMC10485707
Data Availability
The authors confirm that the data supporting the findings of this study are available within the article. If further data are required, reasonable requests in line with ethics approval can be made to the corresponding author (MD).
PMC10485707
Objective:
stroke
STROKE
To examine the effect of low-frequency acupoint electrical stimulation (LFES) on the surface electromyographic (sEMG) signals of the thumb-to-finger movement muscles in stroke patients, and to evaluate the clinical efficacy of LFES on hand function recovery after stroke.
PMC10681496
Methods:
Acupuncture, Stroke
STROKE, DEFICIT
Sixty patients who met the inclusion criteria were randomly assigned to a LFES group or an electroacupuncture (EA) group, with 30 patients in each group. Both groups received conventional treatment, and the EA group was treated with acupoints from the book of Acupuncture and Moxibustion, while the LFES group was treate...
PMC10681496
Results:
After treatment, both groups showed improvement in sEMG characteristic values, Brunnstrom motor function score, Lindmark hand function score, and Lovett muscle strength classification compared with before treatment, and the improvement in the LFES group was significantly better than that in the EA group (
PMC10681496
Conclusion:
stroke
STROKE
Both LFES and EA were effective in restoring thumb-to-finger movement function after stroke, as evidenced by the increased maximum value and root mean square values of the first dorsal interosseous muscle and the extensor pollicis brevis muscle, the decreased CSS score, the increased Brunnstrom motor function score, th...
PMC10681496
1. Introduction
neurological deficits, rupture, Stroke, necrosis
HYPOXIC, STROKE, NECROSIS
Stroke is a lesion caused by blockage or rupture of a blood vessel in the brain, resulting in ischemic and hypoxic necrosis of brain tissue, corresponding neurological deficits and consequent symptoms in the dominant area.Thumb-to-finger is one of the basic movements that the hand can complete, and clinically rehabilit...
PMC10681496
2. Research methodology
PMC10681496
2.2. Treatment protocol
Acupuncture, cerebrovascular disease, Stroke, → five-finger flexion → wrist dorsal extension
DISEASE, CEREBROVASCULAR DISEASE, STROKE
Patients in both groups received conventional treatment in the acupuncture department, and the Chinese guidelines for primary prevention of cerebrovascular disease in the 2021 edition of the Chinese Multidisciplinary Expert Consensus on Stroke Disease MonitoringEA group treatment: refer to the 13th Five-Year Plan textb...
PMC10681496
2.3. Observed indicators
The following subjective and objective indicators were measured before and after treatment in both groups.
PMC10681496
2.3.1. Objective index measurement.
CONTRACTION
Surface electromyographic eigenvalues: 2 main aspects, maximum value (MAX), and root mean square value (RMS). MAX reflects the maximum contraction strength of the measured muscle. RMS is the root mean square of the EMG transient amplitude over time, which reflects the average change in EMG signal and is therefore used ...
PMC10681496
2.3.2. Subjective scale collection.
muscle contraction, muscle paralysis
CONTRACTION
① ② ③ ④ Lindmark hand function score: 0 points: gripping action cannot be completed; 1 point: gripping action can be completed, but cannot resist tiny resistance; 2 points: can hold an object for 5s, but cannot resist medium resistance, or grip is not standard, uncoordinated; 3 points: grip is normal, can hold an objec...
PMC10681496
2.4. Clinical efficacy evaluation
Clinical efficacy was assessed using the nimodipine method as a percentage reduction in CSS score: [(pretreatment score − posttreatment score)/pretreatment score] × 100%. Basic healing: reduction rate ≥ 90%; significant improvement: 46%≤ minus rate < 90%; progress: 18% ≤ minus rate < 46%; The ratio of the sum of basic ...
PMC10681496
2.5. Statistical analysis
±
SPSS26.0 software was adopted for statistical analysis of the collected data. Count data were tested by 2, and measurement data were expressed as mean ± standard deviation (
PMC10681496
3. Research results
PMC10681496
3.1. General information statistics
DISEASE
There were no significant differences between the 2 groups in terms of gender, age and disease duration, which were not statistically significant and comparable. The comparison of gender, age, and course of disease between the 2 groups is shown in Table Comparison of gender age, and duration of disease.
PMC10681496
3.2. Comparison of surface electromyographic characteristic values before and after treatment between 2 groups of patients
PMC10681496
4. Discussion
upper limb spasm, stroke, hand motor function
STROKE, DISEASE, SEQUELAE, DYSFUNCTION
Thumb-to-finger dysfunction is a difficult point in the treatment of stroke sequelae, affecting upper limb function and grasping ability. In this study, thumb-to-finger dysfunction was mainly due to decreased activation of the extensor and flexor muscles of the fingersThe results showed that the 2 therapies improved th...
PMC10681496
5. Conclusion
Both FLES and EA showed efficacy in the reconstruction of motor function of the thumb-index finger movements, as evidenced by the increase in MAX and RMS values of the first interosseous dorsal muscle and thumb short extensor muscle, the decrease in CSS score, the increase in Brunnstrom motor function score, the decrea...
PMC10681496
Abbreviations:
stroke, Stroke
STROKE, STROKE
Chinese Stroke Clinical Neurological Deficit Scaleelectroacupuncturelow-frequency acupoint electrical stimulationModified Ashworth Scalemaximum valueroot mean square valueThe authors have no funding and conflicts of interest to disclose.The datasets generated during and/or analyzed during the current study are not publ...
PMC10681496
References
PMC10681496
Background
ATRIAL FIBRILLATION (AF)
Radiofrequency catheter ablation (RFCA) for patients with atrial fibrillation (AF) can generate considerable physical and psychological discomfort under conscious sedation. App-based mindfulness meditation combined with an electroencephalography (EEG)-based brain-computer interface (BCI) shows promise as effective and ...
PMC10193217
Objective
This study aimed to investigate the effectiveness of a BCI-based mindfulness meditation app in improving the experience of patients with AF during RFCA.
PMC10193217
Methods
pain, Anxiety, Fatigue
ADVERSE EVENTS
This single-center pilot randomized controlled trial involved 84 eligible patients with AF scheduled for RFCA, who were randomized 1:1 to the intervention and control groups. Both groups received a standardized RFCA procedure and a conscious sedative regimen. Patients in the control group were administered conventional...
PMC10193217
Results
BCI-based app–delivered mindfulness meditation, compared to conventional care, resulted in a significantly lower mean numeric rating scale (mean 4.6, SD 1.7 [app-based mindfulness meditation] vs mean 5.7, SD 2.1 [conventional care];
PMC10193217
Conclusions
BCI-based app–delivered mindfulness meditation effectively relieved physical and psychological discomfort and may reduce the doses of sedative medication used in RFCA for patients with AF.
PMC10193217
Trial Registration
NCT05306015
ClinicalTrials.gov NCT05306015; https://clinicaltrials.gov/ct2/show/NCT05306015
PMC10193217
Introduction
fatigue, pain, anxiety, cardiac arrhythmia
ADVERSE EVENTS, ATRIAL FIBRILLATION (AF), COMPLICATIONS, CARDIAC ARRHYTHMIA
Atrial fibrillation (AF) is recognized as the most common cardiac arrhythmia worldwide, with an estimated prevalence of 2%-4% in adults [Considering the longer general anesthesia preparation time, higher economic costs, and potential complications, conscious sedation is used for RFCA at most centers in China [Mindfulne...
PMC10193217
Methods
PMC10193217
Study Design
This was a single-center, 2-arm, parallel-group, prospective, pilot randomized controlled trial. Patients were randomized 1:1 to the intervention and control groups using a computer-generated randomization list. Due to the nature of the study design, neither program implementers nor patients could be blinded to the int...
PMC10193217
Participants
PMC10193217
Overview
cognitive complaints, pain
MALIGNANT TUMORS, SYSTEMIC DISEASE
Patients were eligible for the study if they were (1) diagnosed with AF, (2) at least 18 years old, (3) undergoing their initial RFCA procedure, and (4) willing to participate in the study. Patients were excluded if they had (1) severe systemic diseases such as malignant tumors, (2) a history of mental illness and cogn...
PMC10193217
Intervention Group
Patients in the intervention group received mindfulness meditation guidance delivered through a Chinese-language interface and voice app (Focus Zen, version 2.1.1) along with a BCI-based headband. A mobile phone and a Samsung tablet device with the preinstalled app were prepared in the cardiac catheterization laborator...
PMC10193217
Control Group
pain
The control group received routine care for their ablation procedure and was informed about the procedure of ablation and characteristics of impending pain in ablation, as in the intervention group. Psychological and supportive care were provided in accordance with the patients' needs. However, patients in the control ...
PMC10193217
Outcome Measurements
anxiety, fatigue, pain
Both the intervention and control groups were administered 2 surveys, one 30 minutes before ablation and one within 30 minutes after ablation, to assess pain intensity, fatigue, and anxiety using specific paper questionnaires. Demographic information and characteristics of participants were collected at baseline. The s...
PMC10193217
Statistical Analysis
Statistical analysis was performed using SPSS (version 22.0; IBM Corp) and based on the intention-to-treat principle with a 2-sided significance level of .05. Data were analyzed using descriptive statistics and checked for the normality of their distribution. Descriptive continuous variables are presented as mean (SD) ...
PMC10193217
Ethical Considerations
NCT05306015
This study was conducted at the cardiac catheterization laboratory of the First Affiliated Hospital of Nanjing Medical University, Nanjing, China, from April to September 2022. All study patients provided oral or written informed consent. This study was approved by the ethics committee of the First Affiliated Hospital ...
PMC10193217
Results
PMC10193217
Secondary Outcomes
SECONDARY
Between the intervention and control groups in ablation, there were no significant differences in the mean heart rate (mean 87.4, SD 15.7 [intervention group] vs mean 91.1, SD 16.4 [control group] beats per minute; There were no significant differences in parecoxib and dexmedetomidine use between the intervention and c...
PMC10193217
Discussion
PMC10193217
Principal Findings
fatigue, anxiety, pain
The purpose of this study was to evaluate the effectiveness of a novel BCI-based mindfulness meditation app for patients with AF to improve their physical and psychological status in RFCA. The selected app provides EEG feedback for mindfulness meditation, which may help patients relax and reduce unpleasant experiences ...
PMC10193217
Strengths and Limitations
A strength of this study is that it is the first randomized controlled trial, to our knowledge, to explore the effectiveness of a mindfulness meditation app together with a BCI-based wearable device among patients with AF during RFCA, which adds to the evidence base in the areas of meditation and mobile health. This st...
PMC10193217
Conclusions
fatigue, ZB, anxiety, pain, GS
ADVERSE EVENTS
In conclusion, this study shows that BCI-based app–delivered mindfulness meditation significantly relieved pain, anxiety, fatigue, and may reduce the doses of sedative medication used during RFCA for AF. Although no significant differences in hemodynamic parameters and the incidence of adverse events were observed, the...
PMC10193217
Abbreviations
Anxiety, Fatigue
atrial fibrillationState Anxiety Inventorybrain-computer interfaceBrief Fatigue InventoryConsolidated Standards of Reporting Trialselectroencephalographyradiofrequency catheter ablationperipheral oxygen saturation
PMC10193217
INTRODUCTION:
intraoperative blood oozing
To compare the effectiveness of the novel hemostatic peptide, TDM-621, with that of conventional hemostatic methods in treating intraoperative blood oozing during endoscopic submucosal dissection (ESD).
PMC9889198
METHODS:
ADVERSE EVENTS, EPITHELIAL TUMORS, SECONDARY
This multicenter, open-label, randomized controlled trial involved 227 patients with gastric and rectal epithelial tumors in whom ESD was indicated. Patients in whom the source of blood oozing was difficult to identify with waterjet washing during the procedure and required hemostasis with hemostatic forceps were rando...
PMC9889198
RESULTS:
The mean number of coagulations with hemostatic forceps was significantly reduced in the TDM-621 group (1.0 ± 1.4) compared with that in the control group (4.9 ± 5.2) (
PMC9889198