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Ethics statement | This study was approved by the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences (AJUMS) (Ref. ID: IR.AJUMS.REC.1401.280). The objectives, stages, and conditions of the study were fully explained to all participants, and an informed consent form was obtained from each of them. | PMC10169697 | ||
Study design | The present study was a randomized controlled study conducted after tool development. It was described according to CONSORT (Consolidated Standards of Reporting Trials) Statement available at | PMC10169697 | ||
Settings | This study began in January 2022 and ended in December 2022. The design and development of the AGAH app took about 8 months. Data were collected for 3 months (from October to December 2022) in the operating rooms of 5 university hospitals affiliated with AJUMS. | PMC10169697 | ||
Interventions | The 3 stages of this study were design, implementation, and evaluation. Each of these steps is detailed below. | PMC10169697 | ||
Design phase | The process of designing the AGAH app is shown in | PMC10169697 | ||
Implementation phase | This study was piloted in the operating rooms of 5 university hospitals affiliated with AJUMS from October 2022 to December 2022 (1 academic semester). At the beginning of the semester, second- and third-year nurse anesthesia students were randomly assigned to intervention (AGAH app) and control (paper logbook) groups.... | PMC10169697 | ||
Evaluation phase | The intervention and control groups were evaluated and compared based on the variables of satisfaction and learning outcomes. After the intervention, a post-test satisfaction questionnaire was completed by the members of both groups. The learning outcomes of both groups were measured based on the total score of the pro... | PMC10169697 | ||
Participants | All 49 second- and third-year anesthesia nursing students of AJUMS, including 14 men (28.5%) and 35 women (71.5%) with a mean age of 21±3.65 years, entered the study. Sampling was done using the census method, and informed consent was obtained from the participants. Participants were excluded from the study if they fai... | PMC10169697 | ||
Outcomes | In this study, the following outcomes were investigated: (1) demographic characteristics, (2) the intervention and control groups’ level of satisfaction with the AGAH app and the paper logbook, respectively, and (3) the learning outcomes of the groups after completing the internship. | PMC10169697 | ||
Data sources and measurement | To measure the level of satisfaction of the students, a researcher-made satisfaction questionnaire was used. The first section of this questionnaire dealt with demographic information (age, sex, academic year, and overall grade point average). The second section consisted of 20 items scored based on a 5-point Likert sc... | PMC10169697 | ||
Bias | None. | PMC10169697 | ||
Study size | Sample size calculation was performed using G*Power ver. 3.0.10 (University of Düsseldorf), using the independent-samples Student t-test, 2-tailed alpha of 0.05, power (1-β) of 0.80, and effect size (Cohen d) of 0.8. The result indicated that a sample size of approximately 25 participants per group was required. Theref... | PMC10169697 | ||
Randomization | Forty-nine students were randomly assigned to the intervention and control groups. Each student was randomly assigned a code. Then, the codes were placed in a box. The first code drawn from the box conferred assignment to the intervention group, while the second code represented allocation to the control group. This pr... | PMC10169697 | ||
Blinding (masking) | No blinding was done. | PMC10169697 | ||
Statistical methods | IBM SPSS ver. 25.0 (IBM Corp.) was used for data analysis. The normality of data distribution was confirmed using the Shapiro-Wilk test. Data were analyzed using descriptive (mean, standard deviation, percentage, and frequency) and analytical (independent t-test and chi-square test) statistics. P-values less than 0.05 ... | PMC10169697 | ||
Results | PMC10169697 | |||
Participants | During the 3 months of the study, of the 49 nursing anesthesia students initially participating, only 39 (20 from the intervention group and 19 from the control group) completed all steps of the study ( | PMC10169697 | ||
Main results | The independent t-test was used to compare the mean scores for satisfaction and learning outcomes of the intervention and control groups. The results showed a statistically significant difference between the groups in the mean satisfaction score ( | PMC10169697 | ||
Discussion | PMC10169697 | |||
Key results | The aim of the present study was to design, implement, and evaluate a smartphone-based online electronic logbook (the AGAH app) used to evaluate the clinical skills of nurse anesthesia students in Iran and to compare it with a paper logbook. The results of this study indicated that the mean scores for satisfaction and ... | PMC10169697 | ||
Interpretation | The present study provides a solid answer to the question of how new and technology-based evaluation methods can constitute a suitable alternative to previous evaluation methods in clinical settings. The results showed that the use of a smartphone-based online electronic logbook could lead to higher satisfaction of nur... | PMC10169697 | ||
Comparison with previous studies | The findings of the present research provide support for previous studies on electronic logbooks. For instance, a study conducted by Tamblyn et al. [The above studies resemble the current research in the demonstrated effectiveness of converting paper logbooks into electronic ones. However, the research population of th... | PMC10169697 | ||
Limitations | Despite its strengths, the present study had a few limitations. First, the low internet speed and frequent disconnections may have affected the results. Additionally, the AGAH app was not compatible with the iOS operating system. Other limitations include the small sample size and the time limit for conducting the stud... | PMC10169697 | ||
Generalizability | The findings of the present study not only can help optimize the clinical evaluation of nurse anesthesia students, but also may be useful for students of other fields of medical sciences in Iran. The design of the AGAH app allows department heads and professors of other disciplines to define the relevant procedures and... | PMC10169697 | ||
Suggestions | The present study can be used as a guide to devise cost-effective and up-to-date clinical evaluation methods. Future studies are recommended to investigate the impact of online logbooks (such as the AGAH app) on other variables related to clinical evaluation or among students of other fields of medical sciences. Longit... | PMC10169697 | ||
Conclusion | The findings of this study indicate that smartphone technology can be used as a platform for improving the evaluation of nurse anesthesia students’ clinical skills, leading to increased satisfaction and improved learning outcomes. Through the design and development of a smartphone-based online electronic logbook (the A... | PMC10169697 | ||
Supplementary materials | Supplementary files are available from the Harvard Dataverse: Supplement 1. Design phase.Supplement 2. Satisfaction questionnaire.Supplement 3. Example of anesthesia skills evaluation checklist in the paper logbook.Supplement 4. Audio recording of the abstract. | PMC10169697 | ||
References | Flowchart of the study.Demographic characteristics of the participants (n=39)Values are presented as number (%) or mean±standard deviation.P-value obtained with the chi-square test.P-value obtained with the independent t-test.Comparison of satisfaction and learning outcome between the intervention and control groups (n... | PMC10169697 | ||
Background | Data on the routine use of video-assisted laryngoscopy in peri-operative intubations are rather inconsistent and ambiguous, in part due to small populations and non-uniform outcome measures in past trials. Failed or prolonged intubation procedures are a reason for relevant morbidity and mortality. This study aims to de... | PMC10111720 | ||
Methods | SECONDARY | In this randomized, controlled, three-armed parallel group design, multi-centre trial, a total of more than 2500 adult patients scheduled for perioperative endotracheal intubation will be randomized. In equally large arms, video-assisted laryngoscopy with a Macintosh-shaped or a hyperangulated blade will be compared to... | PMC10111720 | |
Discussion | DISEASE | This randomized controlled trial will provide a solid base of data in a field where reliable evidence is of major clinical importance. With thousands of endotracheal intubations performed every day in operating rooms around the world, every bit of performance improvement translates into increased patient safety and com... | PMC10111720 | |
Trial registration | ClincalTrials.gov NCT05228288. | PMC10111720 | ||
Protocol version | 1.1, November 15, 2021. | PMC10111720 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10111720 | ||
Background | PMC10111720 | |||
Rationale | obese, glottis | OBESE | Endotracheal intubation is the gold standard for airway management under general anaesthesia. Over the course of the past several years, video-assisted laryngoscopy (VAL) has more and more gained in importance in this field and has already found its way into the relevant guidelines for certain settings and situations l... | PMC10111720 |
Hypothesis and experimental approach | Based on the data available to date, it can be assumed that VAL is at least equivalent to direct laryngoscopy also in the context of elective intubations but could increase patient safety in special situations. Therefore, this trial implements a three-arm, parallel group, randomized-controlled design to investigate the... | PMC10111720 | ||
Benefit-risk assessment | All patients receive the medically necessary peri-operative care. According to current knowledge, randomization into one of the three study arms does not per se entail any altered risk for participants. Both conventional laryngoscopy and VAL are established as standard clinical procedures. The fact that, according to t... | PMC10111720 | ||
Choice of comparators | In this study, three different modalities of laryngoscopy for endotracheal intubation will be compared (s. Fig. Examples of different laryngoscopes to be used in each of the three study arms (from left to right): conventional laryngoscope with Macintosh blade, video-assisted laryngoscope with Macintosh-shaped blade, vi... | PMC10111720 | ||
Aims of the study | PMC10111720 | |||
Primary aim | The primary aim of this trial is to study whether VAL is non-inferior to conventional laryngoscopy for endotracheal intubation in the context of elective surgery under general anaesthesia. Non-inferiority hereby refers to the average rate of successful intubations at first attempt from all interventions in a study arm. | PMC10111720 | ||
Further aims | COMPLICATIONS | In addition, several other parameters will be collected, which, individually or in combination, can provide insights into the risk–benefit profile of the interventions examined. In case of previously proven non-inferiority as laid out in the primary hypothesis, substantial differences between the procedures regarding a... | PMC10111720 | |
Methods and design | PMC10111720 | |||
Design | This is a randomized controlled multi-centre study with a three-arm parallel study design (s. Fig. Flow diagramThe “conventional laryngoscopy” study arm serves as a control group in this experimental setup. The two study arms using VAL will initially be combined at the first stage of the analysis to show that the metho... | PMC10111720 | ||
Methods | PMC10111720 | |||
Setting | Pain | EMERGENCY | The main trial site is the Department of Anaesthesiology, Intensive Care Medicine, Emergency Therapy and Pain Therapy at the University Hospital of Wuerzburg. Further participating sites will be located at the departments of anaesthesiology of hospitals of primary and maximum care in Germany, Austria and Switzerland. D... | PMC10111720 |
Interventions | ’s mouth, critically ill | EVENT, CRITICALLY ILL | The preparations for induction of anaesthesia as well as establishing the necessary patient monitoring will take place in accordance with the stipulations of the anaesthetist in charge and with local standards. Randomization will take place electronically on the day of the intervention; the randomization result is comm... | PMC10111720 |
Sample size | The estimation of the appropriate sample size is based on the corresponding Null hypotheses of the primary hypothesis, i.e. the assumption that VAL is inferior to conventional laryngoscopy in terms of first-attempt success rate, irrespective of the kind of blade in use. From clinical experience and previously published... | PMC10111720 | ||
Recruitment | RECRUITMENT, COMPLICATIONS | Given the large number of surgical interventions performed under general anaesthesia at the study centres involved each day and only little restrictive inclusion and exclusion criteria, insufficient numbers of potential study participants are not to be expected. Because the additional burden on the participants while p... | PMC10111720 | |
Blinding | Patients and data analysts will be blinded regarding the allocation of interventions. The randomization result will be communicated to the care providers non-verbally in such a way that the patient will not take note. Before data will be evaluated, the identifying variable names will be made unrecognizable. For the stu... | PMC10111720 | ||
Biometry | The required socio-demographic data as well as data on the surgical procedure will be assessed by chart review beforehand and will be included in the study documentation as source data. All other necessary data are determined and recorded by the investigator or observer during the intervention in real time. The questio... | PMC10111720 | ||
Statistical analysis | H-VAL | EVENTS | The primary outcome is the rate of successful intubations at first attempt as a fraction of dichotomous events. In a first analysis step we test the hypothesis, that neither video assisted laryngoscopy with a Macintosh-shaped blade (M-VAL) nor video assisted laryngoscopy with a hyper-angulated blade (H-VAL) are inferio... | PMC10111720 |
(Serious) Adverse events (SAE / AE) | Death | As all kinds of laryngoscopes and blades used in this study are also widely used in routine clinical practice, we do not expect any trial-specific AEs. However, any definitive failure to successfully place an endotracheal tube using the allocated or subsequently any other device deemed suitable shall be documented as a... | PMC10111720 | |
Ethics, data privacy and data availability | All activities within this trial comply with the Declaration of Helsinki and the principles of Good Clinical Practice (GCP). | PMC10111720 | ||
Ethics approval | The German version of this protocol was approved by the Ethics committee at the Medical Faculty, University of Wuerzburg, Germany (No. 215/21-sc). Any protocol amendments or supplements require review by the responsible ethics committee and will be communicated to the study centres after approval by the committee. | PMC10111720 | ||
Informed consent | Informed consent will be obtained by trained investigators at the respective study sites. The necessary information material and consent forms will be provided by the sponsor of the trial. Patients who are not capable of giving consent and those under legal custody are excluded from participation in the study. | PMC10111720 | ||
Data privacy | Personal data of patients are collected only to the extent required by the study protocol. All data collected through observation of the intervention will be collected in a pseudonymized manner. Only excerpts from the anaesthesia protocol for documentation of vital signs during the intervention will be directly assigna... | PMC10111720 | ||
Data availability | The final data set will remain property of the sponsor. Other parties will not be entitled to have access to the data. The sponsor reserves the right to make individual or all primary data available in anonymized form to other scientists upon request for the purposes of reviewing the conducted and performing own subseq... | PMC10111720 | ||
Roles and responsibilities | In this investigator-initiated trial, the trial sponsor is involved in the study design. Researchers concerned with the preparation of this protocol, data collection and eventually seeking to publish the results are in part employed by the sponsor. The sponsor retains ultimate authority over these activities. | PMC10111720 | ||
Discussion | sore throat, hoarseness, trauma | SORE THROAT, SECONDARY, RECRUITMENT, BLIND | We propose here the protocol for a randomized, controlled, patient-blinded multi- centre trial on the routine use of VAL in a peri-operative anaesthesiologic setting. Although several studies in the broader research area have been conducted in the past, conclusive evidence enabling clear recommendations is still not av... | PMC10111720 |
Funding | Pain | EMERGENCY | This trial is funded through departmental funds of the Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine Pain, University Hospital Wuerzburg, and supported by the German Society for Anaesthesiology and Intensive Care. | PMC10111720 |
Acknowledgements | Not applicable | PMC10111720 | ||
Authors’ contributions | BS contributed to the design of the trial, analysed and interpreted the data, and drafted and revised the manuscript. DE, AM and PP contributed to the design of the trial and acquired the data. UM performed the sample size calculations and drafted the statistical analysis plan. MB and OH contributed to the design of th... | PMC10111720 | ||
Funding | Pain | EMERGENCY | This publication was supported by the Open Access Publication Fund of the University of Wuerzburg. Open Access funding enabled and organized by Projekt DEAL. This trial is funded through departmental funds of the Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine Pain, University Hospital Wuerzb... | PMC10111720 |
Availability of data and materials | Data will be available upon request from the corresponding author after completion of the trial. A model consent form and patients’ information as well as the Mayo High Performance Teamwork Scale and NASA-TLX questionnaires (all in German) as used in this trial can be obtained from the authors upon request. | PMC10111720 | ||
Declarations | PMC10111720 | |||
Ethics approval and consent to participate | All activities within this trial comply with the Declaration of Helsinki and the principles of Good Clinical Practice (GCP). This protocol was approved by the responsible ethics board:Ethics Committee of the Medical Faculty, University of Wuerzburg, ref. 215/21-sc, Jan 18, 2022.Informed consent will be obtained by trai... | PMC10111720 | ||
Consent for publication | Not applicable. | PMC10111720 | ||
Competing interests | The authors declare no competing interests. | PMC10111720 | ||
References | PMC10111720 | |||
Background and objectives | idiopathic frozen shoulder, pain | FROZEN SHOULDER | Frozen shoulder (FS) is characterized by pain and significant loss of active and passive shoulder motion. Strengthening exercises are among the standard exercises used for FS. Neuromuscular exercise (NME) effectively improved pain and the range of motion in shoulder. However, no prior research has looked into the effec... | PMC9854051 |
Methods | idiopathic frozen shoulder | Forty individuals with idiopathic frozen shoulder were randomly assigned to either the experimental group (NME with regular physical therapy, | PMC9854051 | |
Results | Two-by-two mixed analysis of variance (ANOVA) revealed a significant group × time interaction for VAS (F = 29.67; | PMC9854051 | ||
Conclusions | idiopathic FS, rotation and external rotation, pain | NME is superior to strengthening exercises in terms of pain and AROM of shoulder flexion, internal rotation and external rotation in individuals with idiopathic FS. NME could be used to treat individuals with FS. | PMC9854051 | |
Trial registration | Trial registration number: ChiCTR2100054453. Registration date: 17/12/2021. | PMC9854051 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12891-023-06173-8. | PMC9854051 | ||
Keywords | PMC9854051 | |||
Introduction | fibrosis, pain | DISEASE, FIBROSIS, ADHESIVE CAPSULITIS, FROZEN SHOULDER, PROGRESSIVE INFLAMMATION | Frozen shoulder (FS) or adhesive capsulitis is an unknown intrinsic disease associated with spontaneously progressive inflammation and fibrosis of the shoulder joint capsule, characterised by pain and significant loss of active and passive shoulder motion [Sensory and proprioceptive input may be reduced if the shoulder... | PMC9854051 |
Materials and methods | PMC9854051 | |||
Study design | MAY | This was a single-blinded, randomised controlled trial conducted in the rehabilitation medicine department of a regional hospital. Forty participants were recruited from December 2021 to May 2022. They were randomly assigned to either NME plus regular physical therapy (experimental group) or regular physical therapy wi... | PMC9854051 | |
Randomization and blinding | Eligible participants were randomly assigned to the experimental or control group by a blinded investigator using computer-generated random numbers through concealed opaque envelopes. An independent blinded therapist assessed participants and collected data at baseline and 8 weeks after treatment. After the baseline ex... | PMC9854051 | ||
Participants | idiopathic FS [, idiopathic frozen shoulder, shoulder pain | ADHESIVE CAPSULITIS | Forty participants who have been diagnosed with idiopathic frozen shoulder were recruited from a regional hospital for this study. The inclusion criteria include: (1) FS (adhesive capsulitis) diagnosed at the freezing or frozen stage. (2) symptoms such as shoulder pain, stiffness and joint mobility limitations (limited... | PMC9854051 |
Interventions | Participants in both the experimental group (EG) and the control group (CG) performed a 5-minute warm-up exercise in the form of wall climbing at the beginning and received 40 minutes of regular physical therapy. Participants from CG performed 20 minutes of strengthening exercises. Participants in EG performed NME for ... | PMC9854051 | ||
Regular physical therapy | Regular physical therapy included Maitland mobilization techniques, stretching exercises and active range of motion exercises [ | PMC9854051 | ||
Strengthening exercises | rotation and external rotation, abduction | Strengthening exercises included isometric and isotonic exercises. Theraband isometric exercises and 1–2-kg dumbbells isotonic exercises were performed for flexion, extension, abduction, internal rotation and external rotation in a standing and lying position. Ten seconds/set, 10 sets for each direction for isometric e... | PMC9854051 | |
NME | abduction | NME used the HUBER360NME for the left shoulder in external rotationNME for the left shoulder in abduction 90° and external rotationNME for the left shoulder in flexion 90° and external rotation | PMC9854051 | |
Outcome assessments | shoulder flexion, abduction, pain | After the treatment and at the beginning of the study, all outcomes were assessed. The same experienced therapist collected data on basic demographic factors such as age, gender, duration of symptoms, stage, affected side and clinical outcomes such as pain and active range of motion (AROM).Pain intensity was assessed u... | PMC9854051 | |
Sample size calculation | The sample size calculation was based on the time-by-group interaction of a two-by-two mixed analysis of variance (ANOVA). The effect size was estimated to be 0.25 with 80% power and an α-value of 0.05. G*Power v.3.1.9.2 was used for this calculation. The estimated required sample size was 17 individuals per group. Con... | PMC9854051 | ||
Statistical analysis | All statistical analyses were performed using SPSS version 19.0 | PMC9854051 | ||
Discussion | pain | This study aims to investigate the effects of NME compared to strengthening exercises on pain intensity and AROM in individuals with FS. Significant improvements in VAS, AROM of flexion, internal rotation, and external rotation in the experimental group have been observed in this study. | PMC9854051 | |
Evaluation of the effect of neuromuscular exercise on pain | pain | The results show that pain intensity improved significantly in individuals with FS after an intervention of 40 sessions of NME plus regular physical therapy. These results are consistent with the results of other studies [ | PMC9854051 | |
Evaluation of the effect of neuromuscular exercise on AROM | CHRONIC SHOULDER PAIN | A significant difference was found in the AROM of flexion, internal rotation, and external rotation between the group with NME plus regular physical therapy and the group with regular physical therapy plus strengthening exercises. Shoulder AROM improved after 5 weeks of neuromuscular control exercises in subjects with ... | PMC9854051 | |
Limitations of the study | First, the sample size in this study was relatively small. Second, it is unclear whether the frequency, intensity, and duration of NME by the motorized device were the best in this study, and there is no previous study to compare it with. Third, only the VAS score and AROM of the shoulder were measured in this study, a... | PMC9854051 | ||
Conclusions | pain | FROZEN SHOULDER | This study shows that NME performed with a motorized device in combination with regular physical therapy in the form of joint mobilization, stretching, and AROM at FS is more effective for pain relief and improvement of AROM compared with regular physical therapy with strengthening exercises. Considering the positive e... | PMC9854051 |
Suppliers |
Huber360 MD; LPG Systems.SPSS; IBM Corp. | PMC9854051 | ||
Acknowledgements | We would like to thank every individual who participated in this study. | PMC9854051 | ||
Authors’ contributions | L.W. and Y.C. designed the research study. L.W. participated in the data collection/analysis and writing of the manuscript. G.Y., R.Z., G.W., L.H. participated in the data collection and analysis. Y.C. provided experimental guidance during the study and revised the paper critically. All authors read and approved the fi... | PMC9854051 | ||
Funding | The study did not receive any specific funding from funding agencies in the public, commercial or non-profit sectors. | PMC9854051 | ||
Availability of data and materials | The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC9854051 | ||
Declarations | PMC9854051 |
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