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RESULTS
PMC10802776
Description of the population
The first subject was enrolled, randomized, and assessed on January 13, 2020; the last subject was screened on July 22, 2020 ( Enrollment, randomization, and follow-up regarding the effect of vertical positioning on lung aeration.The baseline characteristics of the participants are shown in Baseline characteristics
PMC10802776
Primary outcome
LUNG
The LUS values across different study time points are shown in Study outcomesLung ultrasound score in different postures Lung ultrasound score across different verticalization interventions. Lung ultrasound scores of patients receiving invasive mechanical ventilation through an endotracheal tube in different postures.
PMC10802776
Secondary outcomes
hypotension, orthostasis, SD, tachycardia
ADVERSE EVENTS
The median tidal volumes for passive orthostasis and the sitting position were 436mL (IQR 395 - 507) and 435mL (IQR 380 - 480), respectively (p = 0.47). The mean respiratory rates for passive orthostasis and the sitting position were 24.7 (SD 6.1) and 24.2 (SD 6.0), respectively (MD -0.47; 95%CI - 4.1 - 3.1; p = 0.78)....
PMC10802776
Feasibility
RECRUITMENT
There were no significant protocol deviations during the study regarding recruitment procedures, informed consent, intervention administration, or outcome assessment. All included subjects met all the inclusion criteria, and none had any exclusion conditions. Informed consent was obtained from all participants. Althoug...
PMC10802776
DISCUSSION
critically ill, orthostasis
ADVERSE EVENTS, CRITICALLY ILL
The present crossover randomized clinical trial comparing the effect of passive orthostasis using a tilt-table with a standard sitting position on lung aeration in mechanically ventilated critical care patients found no difference between the interventions. Although no difference in lung aeration was found between the ...
PMC10802776
CONCLUSION
orthostasis
Considering the findings, our study does not allow us to draw generalized conclusions. Even so, we speculate that the verticalization of the chest performed through sitting and passive orthostasis positioning does not generate changes in lung aeration, as assessed by ultrasound. We emphasize that such findings need to ...
PMC10802776
REFERENCES
PMC10802776
Background
Coronary chronic total occlusion (CTO) interventions are more complex than general percutaneous coronary intervention (PCI) procedures. However, only a few nursing methods are specifically applied to patients undergoing CTO interventions. And the conventional nursing effect is not ideal, urgent need to explore more eff...
PMC10688462
Objective
anxiety
ADVERSE EVENTS
This study aimed to investigate the effectiveness of a checklist-based nursing care process in patients undergoing Coronary chronic total occlusion (CTO) interventions, including duration of care, patient anxiety, improved patient satisfaction, and occurrence of adverse events.
PMC10688462
Methods
A total of 120 CTO patients undergoing percutaneous coronary intervention (PCI) were selected at our hospital and divided into an intervention group (
PMC10688462
Results
ADVERSE EVENTS
The intervention grouphad significantly shorter preoperative nursing care time and significantly lower the total number of adverse events than the control group (
PMC10688462
Conclusion
anxiety, ’
ADVERSE EVENTS
The application of the checklist-based nursing care process in patients with CTO intervention can significantly reduce the preoperative nursing care time, reduce patient anxiety, improve patients’ and doctors’ satisfaction with nursing care, and effectively reduce the occurrence of adverse events caused by nurses’ omis...
PMC10688462
Trial registration
The protocol of the trial was registered retrospectively of Chinese Clinical Trial Registry (registration number ChiCTR2200056804, reg date17/02/2022).
PMC10688462
Keywords
PMC10688462
Background
Q-wave, non-occlusive disease, anxiety
ADVERSE EVENTS, CEREBROVASCULAR ACCIDENT, CORONARY ARTERY DISEASE
Coronary chronic total occlusion (CTO) is a common type of lesion in patients with coronary artery disease, and percutaneous coronary intervention (PCI) serves as one of the primary treatment methods for CTO patients [Traditionally, PCI for non-occlusive disease was considered a low-risk procedure for patients with sta...
PMC10688462
Methods
PMC10688462
Study design
Our study began with the formulation of the checklist.The design of the checklist was based on the latest version of the 2020 Chinese Interventional Guidelines, CTO Guidelines, and related literature, combined with the current situation of the department where the work was conducted, to develop a list of nursing tasks ...
PMC10688462
Sample and setting
Patients who underwent CTO intervention in the Department of Cardiology, Shengjing Hospital, China Medical University, in Shenyang, China, from December 2020 to July 2021, were selected.The inclusion criteria were as follows: [The exclusion criteria were as follows: [
PMC10688462
Interventions
Anxiety
ADVERSE EVENTS
Intervention group: The checklist-based nursing care process was used to provide care and education to patients with CTO before and after PCI, and the specific contents and methods are as follows. A paper version of the checklist-based nursing process required for the study was also printed. After the patient with CTO ...
PMC10688462
Measurements
bleeding, anxiety, site injury, postoperative urinary difficulties, hematoma
ADVERSE EVENTS, BLEEDING, HEMATOMA
Preoperative nursing care time. This refers to the sum of time spent by the primary nurse on all matters related to preoperative preparation, which was timed by the primary nurse herself.The less total preoperative nursing care time, the less the work time.Occurrence of adverse events due to nurse’s omission or inadequ...
PMC10688462
Validity and reliability of instruments
Cronbach’s α of SAS was 0.932.The content validity index of the nursing care checklist for CTO patients was 0.82, and internalconsensus reliability Cronbach’s α coefficient was 0.859. The content validity index of theDoctors’ Satisfaction with Nursing Care Questionnairewas 0.85, and internalconsensus reliability Cronba...
PMC10688462
Randomization
BLIND
Doctors use random sequence software to generate 1 to 120 random serial numbers. Random serial numbers and then in the order in which the patients were treated, from front to back. Odd-numbered patients were included in the intervention group, while even-numbered patients were included in the control group. In order to...
PMC10688462
Sample size
Group sample sizes of 43 and 43 achieve 90% power to reject the null hypothesis of equal means when the population mean difference of preoperative nursing care time is 5 min and - with a standard deviation for both groups of 7 min and with a significance level (alpha) of 0.050. Assuming a 20% potential dropout rate, th...
PMC10688462
Statistical analysis
SPSS 26.0 software was used for statistical analysis. Measurement data were expressed as (‾x ± s), and the t test was used for comparison between groups. Count data were expressed as number of cases or percentage, and the χ2 test was used for comparison between groups. The difference was considered significant at
PMC10688462
Result
PMC10688462
The basic information between the two groups
Among the 120 patients, 109 completed the study, and 11 patients did not complete the questionnaire due to early discharge from the hospital. The final intervention group included 56 patients with mean age of (65.05 ± 10.14) years, and the control group included 53 patients with mean age of (65.02 ± 10.73) years. No si...
PMC10688462
Preoperative nursing care time
The average preoperative nursing care time in the intervention group was 37.61 ± 5.15 min, which was much lower than the 50.98 ± 5.61 min in the control group. In the intervention group, 71.4% and 28.6% of the patients had preoperative nursing time < 40 and 40–50 min, respectively, and all patients had preoperative nur...
PMC10688462
Occurrence of adverse events
dysuria, bleeding, hematomas, vomiting
PRESSURE SORE, BLEEDING, HEMATOMAS, ADVERSE EVENTS, ADVERSE EVENT
Preoperatively, the intervention group had indwelling venous access in the wrong limb and one venous access blockage, while the control group had two non-indwelling venous accesses, two indwelling venous accesses in the wrong limbs, and three blocked venous accesses. Intraoperatively, vomiting and defecation did not oc...
PMC10688462
Patient anxiety
anxiety
Most patients in both groups had different levels of anxiety before surgery, and the difference in SAS scores was not significant (P > 0.05).There was no significant difference in the number of people with no anxiety, mild anxiety, moderate anxiety and severe anxiety (P > 0.05). The postoperative SAS scores decreased i...
PMC10688462
Doctor and patient satisfaction
ADVERSE EVENTS
The doctor and patient satisfaction scores of the intervention group were higher than those of the control group. The implementation of the checklist-based nursing care was effective in enhancing doctor and patient satisfaction with nursing care, and a significant difference was found between the two groups ( The basic...
PMC10688462
Discussion
Anxiety, anxiety, depression, acute coronary syndrome, defecation difficulties, intraoperative vomiting or defecation
ADVERSE EVENTS, ADVERSE EVENT, PRESSURE SORE, ACUTE CORONARY SYNDROME
At present, there is no unified standard and consensus on the nursing care process before and after PCI procedures in China, and various medical units have discussed the nursing care methods for patients undergoing PCI procedures from different nursing perspectives [This study showed that the nurses in the intervention...
PMC10688462
Clinical implementation
confusion
ADVERSE EVENTS
The nursing checklist used in this study can be applied to the perioperative care of clinical CTO patients undergoing PCI. Nurses refer to the checklist to implement nursing measures for patients one by one, and mark the completed items before completion to avoid omissions and confusion. Its content is clear and concis...
PMC10688462
Research recommendation and future considerations
This study is the first time that Checklist-based Nursing has been applied to the care of patients undergoing CTO interventional operation. Therefore, more randomized controlled trials should be conducted using other feasible nursing methods to identify the best and most effective nursing methods for CTO interventional...
PMC10688462
Research strengths and limitations
coronary artery disease
VASCULAR DISEASE, CORONARY ARTERY DISEASE, COMPLICATIONS
In Chinese studies, studies on improving nurses’ work efficiency before and after PCI are rarely found in the literature, and there are even fewer nursing processes solely for CTO patients. Starting from the nurses themselves, this study is the first to apply the checklist to patient nursing for CTO interventional proc...
PMC10688462
Acknowledgements
Not applicable.
PMC10688462
Authors’ contributions
Made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data: Xia Ge, Zhe Zang, Haiyang Wu. Involved in drafting the manuscript or revising it critically for important intellectual content: Xia Ge, Jiayi Xie. All authors read and approved the final manuscript.
PMC10688462
Funding
This research was funded by a grant from Shengjing Hospital of China Medical University.
PMC10688462
Data Availability
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
PMC10688462
Declarations
PMC10688462
Ethics approval and consent to participate
The purpose of this study is to establish a perfect nursing process, so that nurses can improve nursing efficiency in their work, without causing any loss to patients and without relevant invasive operations. This study followed the Declaration of Helsinki [
PMC10688462
Consent for publication
Not applicable.
PMC10688462
Competing interests
The authors declare that they have no competing interests.
PMC10688462
References
PMC10688462
Background
AUD
DISORDER, SECONDARY, LITTLE
Alcohol Use Disorder (AUD) is one of the most stigmatized diagnosis, and stigma imposes a major barrier to treatment seeking. There is a need to develop interventions that can reduce stigma and increase treatment seeking. Little is known about the effects of video materials. The aim of this study was to investigate eff...
PMC10552234
Methods
REGRESSION, BLIND
This is a three-armed double blind randomized controlled study. The study included 655 Danish adults. Data was collected at a study webpage, and the survey could be completed anywhere with Internet access. After informed consent and completing baseline measures, participants were randomized, 1:1:1 ratio, to a video (vi...
PMC10552234
Results
In total n = 616 completed follow-up (video 1 n = 215; video 2 n = 192; video 3 n = 209). Randomization to video 1 and 3 decreased public stigma measured with “Difference, Disdain & Blame Scales”, while video 2 increased stigma. Video 2 compared to 1: 2.262 (95% CI 1.155; 3.369)
PMC10552234
Conclusions
ADVERSE EFFECTS
Videos can have an immediate effect on level of public stigma. Other types of interventions are needed to increase motivation and reduce self-stigma. To avoid adverse effects in future interventions, the use of theoretical frameworks and stakeholder involvement is emphasized.
PMC10552234
Supplementary Information
The online version contains supplementary material available at 10.1186/s12889-023-16811-4.
PMC10552234
Keywords
Open access funding provided by Karolinska Institute.
PMC10552234
Background
psychiatric disorder, AUD, SUD
DISORDER
Alcohol use disorder (AUD) is the most prevalent substance use disorder (SUD), directly affecting 100.4 million individuals worldwide [Even though AUD is common, it is among the most highly stigmatized psychiatric disorder in the Western world [Stigma has a range of negative consequences for individuals with AUD. On a ...
PMC10552234
The role of mass media campaigns
In Denmark, 98% of the population use the Internet, and 84% are active on social media [Interventions based on education and on increasing social contact between groups have been shown to be effective in reducing public stigma [Mass media campaigns have the potential both to reduce stigma and also increase treatment se...
PMC10552234
The RESPEKT campaign
RESPEKT
SECONDARY
The Danish NGO-organization “Alkohol & Samfund” [English: “Alcohol & Community”] and the private Foundation “Trygfonden” [aimed at supporting research and prevention-initiatives], in cooperation with media / PR agencies and local alcohol treatment services, have developed a media campaign, “RESPEKT,” which has been bro...
PMC10552234
Methods
PMC10552234
Study-design
BLIND
This is a three-armed double blind randomized controlled study.
PMC10552234
Participants
The participants, adults 18 years and older, were recruited via convenience sampling.
PMC10552234
Procedure
A study webpage was launched in year 2020, after the RESPEKT mass media campaign period was completed [ The RESPEKT video featuring the boy and father at the football ground [The RESPEKT video featuring the boy and father at home [A video beginning: “Are you worried that you drink too much? Have others told you that, o...
PMC10552234
Data collection
DISORDER, ABUSE
Data was collected at the study webpage, and submitted to the REDCap database hosted by OPEN [The baseline measures included: Demographic data on gender, age, education, marital status, children, country of birth and occupational status.Alcohol use, assessed with Alcohol Use Disorder Identification Test – consumption (...
PMC10552234
Data analyses
MP
REGRESSION
Characteristics of participants at baseline were reported for the overall sample and separately for the three exposure groups. Counts and proportions were reported for categorical characteristics.The numerical data on public stigma, motivation to change one’s own alcohol use, motivation to talk to someone else about th...
PMC10552234
Results
Of 848 participants who entered the study, 72% (n = 655), completed the baseline measures and were randomized (Fig.  Consort flow diagramThe majority of participants were female (75%) and the mean age was 43 (SD 14). A majority, 68%, had an employment, while circa 20% were students (Table  Demographic of participants w...
PMC10552234
Post hoc analyses
PMC10552234
Motivation to change own alcohol use – grouped according to level of motivation
All groups, but participants with low motivation at baseline randomized to group 1, decreased their motivation to change one’s alcohol use from pre to post measure (Table  Post hoc analyses of within and between group differences in motivation to change one’s own alcohol use. Participants grouped according to level of ...
PMC10552234
1.3.2. Post hoc analyses
PMC10552234
Motivation to change own alcohol use – grouped according to level of alcohol use
There was a decrease in motivation to change one’s alcohol use in all groups, except among participants with low-risk alcohol use randomized to video 1 (Table  Post hoc analyses of within and between group differences in motivation to change one’s own alcohol use. Participants grouped according to level of alcohol use ...
PMC10552234
Discussion
PMC10552234
Level of public stigma
The a priori hypothesis, that Video 1 is set in a context common for many in the general Danish population - children and parents at football. This can potentially question the stereotype that individuals with AUD are different from others [Video 2 depicted a father with probably severe AUD, asleep on a sofa. While the...
PMC10552234
Motivation to change one’s own alcohol use
Overall, the Available evidence on both mass media campaigns aiming to reduce alcohol and tobacco harm, show that campaign messages including reasons to make a change, so called “why-messages”, and messages that address long-term harms of alcohol, are more effective in strengthening motivation to change, compared to ca...
PMC10552234
Motivation to seek treatment for AUD
Participants randomized to video 2, decreased their A recent cross-sectional survey showed a positive association between engaging in social media posts of others change of alcohol use or treatment seeking for AUD, and own self-reported treatment seeking [
PMC10552234
Motivation to talk to someone else about their alcohol use
SECONDARY
The social network around individuals with AUD was a secondary target group of the RESPEKT campaign. Social support is an important factor for seeking AUD treatment [
PMC10552234
Self-stigma
Nor were any effects on
PMC10552234
Strengths and limitations
The use of self-report measures, can pose an increased risk of socially desirable answers. A stigma questionnaire measuring differentness was used, which is considered to impose less risk of bias [Moreover, the study focused on immediate effects of randomization to different videos. This exposure may not be transferabl...
PMC10552234
Conclusions
Video materials focusing on recovery and reducing the perception of differentness have an immediate effect on decreasing public stigma associated with AUD. The unexpected detrimental effects highlight the need for careful considerations, use of theoretical frameworks and stakeholder involvement in the development of vi...
PMC10552234
Acknowledgements
Not applicable.
PMC10552234
Author contributions
SWF conceptualization, methodology, data curation, statistical analysis, writing original draft preparation. AM methodology, statistical analysis, writing reviewing, editing. RB methodology, writing reviewing, editing. ANS conceptualization, methodology, writing reviewing, editing.
PMC10552234
Funding
TrygFonden, grant number 129450. The funding source had no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.Open access funding provided by Karolinska Institute.
PMC10552234
Data Availability
The data underlying this article cannot be shared publicly due to the privacy of individuals that participated in the study. The data will be shared on reasonable request to the corresponding author.
PMC10552234
Declarations
PMC10552234
Ethics approval and consent to participate
The study was approved by the Research Ethics Committee at the University of Southern Denmark on the 14th of January 2021, registration number: 20/70424. All participants gave their informed consent to participate. The study was performed in accordance with the Declaration of Helsinki.
PMC10552234
Consent for publication
Not applicable.
PMC10552234
Competing interests
We have no conflict of interest to report.
PMC10552234
List of abbreviations
Alcohol Use DisorderAlcohol Use Disorder Identification Test ConsumptionCompletely Automated Public Turing test to tell Computers and Humans ApartConfidence IntervalsCommunity Reinforcement and Family TrainingSubstance Use DisordersVisual Analogue Scale
PMC10552234
References
PMC10552234
Subject terms
TYPE 2 DIABETES
Transcutaneous electrical nerve stimulator (TENS) has been demonstrated to be beneficial in glycemic control in animal models, but its application in humans has not been well studied. We randomly assigned 160 patients with type 2 diabetes on oral antidiabetic drugs 1:1 to the TENS study device (n = 81) and placebo (n =...
PMC9932095
Introduction
diabetic chronic complications, type 2 diabetes, postprandial hyperglycemia
TYPE 2 DIABETES
Despite numerous treatment options available, many patients with type 2 diabetes fail to achieve glycemic targets, leading to a significantly increased risk for diabetic chronic complications and related morbidity/mortalityTranscutaneous electrical nerve stimulator (TENS) is an approach that applies electrical impulses...
PMC9932095
Results
PMC9932095
Secondary outcome
The proportion of subjects achieving HbAFPG at each visit for ITT and PP populations are shown in Supplementary Table According to subgroup analysis (Supplementary Table
PMC9932095
Other outcomes
tumor necrosis
TUMOR NECROSIS
The 7-point SMBG was measured immediately before breakfast, lunch, and dinner, two hours after each meal, and at bedtime, at week 0, 4, 12 and 20. In the TENS group, the 7-point SMBG maintained relatively more stable GV compared to the placebo group, as reflected by the significant difference of MAGE at week 20 between...
PMC9932095
Discussion
hyperglycemia, hypoglycemic, Hypoglycemia, diabetes
HYPERGLYCEMIA, DIABETES, BLIND, EVENTS, TYPE 2 DIABETES, HYPOGLYCEMIA
This was a phase 3, prospective, double blind, randomized, placebo-controlled, multi-center, pivotal study to investigate the efficacy and safety of TENS in improvement of glycemic control in patients with type 2 diabetes. The primary efficacy endpoint is to compare the HbAHowever, according to the subgroup analysis, w...
PMC9932095
Methods
PMC9932095
Study design and participants
type 2 diabetes
TYPE 2 DIABETES, BLIND
This was a multi-center, prospective, double blind, randomized, placebo-controlled trial of transcutaneous electrical nerve stimulator (TENS) to improve glycemic control in patients with type 2 diabetes (ClinicalTrials.gov Identifier: NCT03102424). The study and all experimental protocols were approved by Institutional...
PMC9932095
Study intervention
traumatic scars
DIABETES MELLITUS
Study visits occurred every 2 or 4 weeks depending on the study phase. The study device “Dragon Waves Resonant Home Care” Transcutaneous Electronic Nerve Stimulator (Taiwan Resonant Waves Research Corporation, Taipei, Taiwan) is a small portable, battery-operated device equipped with wires and 2 patches, and the impuls...
PMC9932095
Outcome assessments
tumor necrosis, TNF-α
TUMOR NECROSIS
Primary efficacy variable was the change in HbAWe also measured the changes in biomarkers C-reactive protein (CRP), adiponectin, tumor necrosis factorα (TNF-α), fibroblast growth factor-21 (FGF-21), as the exploratory assessments. CRP was determined by latex enhanced immunoturbidimetric assay (ADVIA 1800, ADVIA Chemist...
PMC9932095
Measurements and definitions
There were three analysis populations: intention-to-treat (ITT) population, per-protocol (PP) population, and safety population. Both ITT and PP populations were applied to efficacy analyses, while safety population was used in the analysis of safety variables. Definition of the three populations is detailed in the Met...
PMC9932095
Statistical analysis
The statistical analysis and data management including double data entry, data verification, data validation was performed periodically after receiving case report forms from sites. The statistical analyses were conducted using SAS
PMC9932095
Supplementary Information
The online version contains supplementary material available at 10.1038/s41598-023-29791-7.
PMC9932095
Acknowledgements
We thank Professors June-Tai Wu, Pei-Lung Chen, Chi-Tai Fang, and Dr. Yu-Ling Huang for their critical review and valuable discussion about this manuscript. We sincerely thank the clinical trial participants for their precious contribution of time and effort to the study.
PMC9932095
Author contributions
J.Y.L., H.Y.O., and L.M.C. developed the concept for this article. C.Z.W., C.Y.Y., J.Y.J., C.H.L., Y.D.J., T.J.C., Y.C.C., W.C.W., H.Y.L., Y.F.D., C.H.L., H.C.H., K.J.T., N.C.Y., S.Y.L., N.C.Y., S.Y.L., H.I.Y. enrolled their patients into this study. M.L.H. performed the FGF-21 assay. J.Y.L., H.Y.O., and L.M.C. analyze...
PMC9932095
Funding
LIVER DISEASE
This clinical trial was funded by the Liver Disease Prevention and Treatment Research Foundation, the Taiwan Resonant Waves Research Corporation and a grant (106-EC-17-A-22-I5-0-005) from the Ministry of Economics, Taiwan. The study machines and glucose meters used in this trial were provided by the Taiwan Resonant Wav...
PMC9932095
Data availability
The data that support the findings of this study are available from Bestat Pharmaservices Corporation, but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the corresponding author upon reasonabl...
PMC9932095
Competing interests
The authors declare no competing interests.
PMC9932095