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Supporting information | (XLSX)Click here for additional data file. | PMC10653471 | ||
1. Introduction | nausea, headaches | ADVERSE EFFECTS | Augmented reality (AR) has been shown to improve productivity in industry, but its adverse effects (e.g., headaches, eye strain, nausea, and mental workload) on users warrant further investigation. The objective of this study is to investigate the effects of different instruction methods (i.e., HoloLens AR-based and paper-based instructions) and task complexity (low and high-demanding tasks) on cognitive workloads and performance. Twenty-eight healthy males with a mean age of 32.12 (SD 2.45) years were recruited in this study and were randomly divided into two groups. The first group performed the experiment using AR-based instruction, and the second group used paper-based instruction. Performance was measured using total task time (TTT). The cognitive workload was measured using the power of electroencephalograph (EEG) features and the NASA task load index (NASA TLX). The results showed that using AR instructions resulted in a reduction in maintenance times and an increase in mental workload compared to paper instructions, particularly for the more demanding tasks. With AR instruction, 0.45% and 14.94% less time was spent on low- and high-demand tasks, respectively, as compared to paper instructions. According to the EEG features, employing AR to guide employees during highly demanding maintenance tasks increased information processing, which could be linked with an increased germane cognitive load. Increased germane cognitive load means participants can better facilitate long-term knowledge and skill acquisition. These results suggested that AR is superior and recommended for highly demanding maintenance tasks since it speeds up maintenance times and increases the possibility that information is stored in long-term memory and encrypted for recalls.The overall complexity of maintenance and assembly tasks grows as product mass customization increases [Traditionally, instructions for maintenance tasks are delivered to workers on paper with expert assistance [The recent developments in interactive multimedia mediums provide promising solutions for the weaknesses and limitations of the traditional paper-based instruction method. For instance, augmented reality (AR) technology is a powerful tool that overlays virtual information produced by computers into a real environment, which promotes experience and interaction [Cognitive load is defined as “the amount of cognitive effort being put into working memory at any particular time” [In comparison with traditional training methods, previous researchers focused mainly on the effectiveness of AR as a training or guiding tool based on task completion time and success rate. Previous research has shown that presenting task instructions via an AR display reduced errors and time to complete tasks while maintaining high levels of technology acceptance from operators [The electroencephalogram (EEG) is an emerging, noninvasive, affordable, and portable neuroimaging modality used to record voltage fluctuations occurring as ionic current flows inside the brain’s neurons [Previous studies have utilized EEG trends in various frequency bands to evaluate the cognitive characteristics of performance in different fields. Sassaroli et al. [This study aims to advance the body of knowledge relative to evaluating cognitive workload while using AR systems in the training of maintenance and assembly tasks. To accomplish this goal, both subjective and objective measurement methodologies are considered to evaluate cognitive workload during real-world representations of maintenance tasks. Therefore, the main objective of this study is to investigate the effects of different instruction methods (AR-based and paper-based instruction) and task complexity on cognitive workload and performance. The cognitive workload is evaluated by the EEG power spectrum density of alpha, beta, and theta in the frontal, central, occipital, temporal, and parietal brain regions and by perceived workload (NASA-TLX). The current study seeks to answer the following question: how do AR-based instruction methods with various demanding tasks affect human cognitive load (i.e., brain activity and perceived workload) and performance (completion time)? It was hypothesized that performing the experimental maintenance tasks with AR-based instructions would be linked with a higher cognitive load as participants must simultaneously attend to information in both real and virtual form. Yet, it was also anticipated that AR-instructions would improve performance time since they facilitate easier information availability as compared to traditional instructions. | PMC10536580 |
2. Materials and Methods | PMC10536580 | |||
2.1. Apparatus | BRAIN | The maintenance tasks were performed on a piston pump subsystem. This piston pump is part of the “GUNT” Practice Line for assembly, maintenance, and repair, which is designed for students and technicians’ training (set: MT 184, Assembly & Maintenance Exercise: Piston Pump). A screwdriver, a wrench, a soft hammer, a jig, and a bearing puller were all needed to complete the tasks on the piston pump. Two instruction methods (Microsoft HoloLens and paper instructions) were used to guide the participants to complete the maintenance tasks. The maintenance instructions for the two tasks were communicated via the Microsoft HoloLens AR system. The paper instruction manuals for the two tasks were developed based on the manual provided by the manufacturer (Gunt technology Ltd., Barsbüttel, Germany). A Live Amp wireless amplifier (Brain Products, GmbH, Gilching, Germany) with 32 channels (weighing 60 g) was used for amplifying and digitizing EEG signals. To hold the EEG electrodes, a black sub-inion cap (EASYCAP, Brain Products GmbH, Gilching, Germany) with an integrated chin made of soft, high-comfort fabric was used. A brain vision recorder system (Brain Products GmbH, Gilching, Germany) was used for recording EEG signals. | PMC10536580 | |
2.2. Participants | injury to the arms, legs, allergic reaction, sleep disturbance, articular pain | NERVOUS SYSTEM DISORDER, MUSCULOSKELETAL DISORDER, ALLERGIC REACTION | Twenty-eight healthy male university students with a mean age of 32.12 (SD 2.45) years from King Saud University, Riyadh, were recruited via opportunity sampling. The minimum, maximum, and median ages of the participants were 27, 35, and 32.5 years, respectively. A self-reported screening survey was adapted to exclude participants with a pre-existing orthopedic surgery, nervous system disorder, articular pain, a history of musculoskeletal disorder, injury to the arms, legs, or spine, or a heart and/or lung problem, an allergic reaction to any adhesive and gel materials used in this study, or sleep disturbance in the two weeks prior to the experiment. Moreover, each participant was also asked to avoid eating two hours before training or data collection. Participants were also instructed to have a normal amount of sleep (approximately six hours of sleep each night) and refrain from engaging in any excessive physical activity before the experimental sessions. Participants in the experiment were selected so that they had little to no background information about the task to be performed.The IRB’s approval for this experiment was obtained from the Human Participants Review Sub-committee, the Institutional Review Board, King Khalid University Hospital, the College of Medicine, and King Saud University. The approved written informed consent form (ethical approval code: E-19-4467) was readied and signed by each participant before participating in the experiment. | PMC10536580 |
2.3. Experimental Design | A 2 × (2 × 14) mixed design was implemented to represent the experimental design with one between-subject variable and one within-subject variable. The first independent variable, which was treated as a between-subject variable, is the instruction methods at two levels (i.e., AR-based instructions and paper-based instructions). The second independent variable, which was treated as a within-subject variable, is the task complexity with two levels (i.e., low-demanding task and high-demanding task). The dependent variables were the EEG power spectrum density of alpha, beta, and theta in the frontal, temporal, parietal, and occipital brain regions and the perceived workload (NASA-TLX). | PMC10536580 | ||
2.4. Maintenance Tasks | The maintenance tasks used in this study are the same as those used in Alhaag et al. [ | PMC10536580 | ||
2.5. Instruction Methods | PMC10536580 | |||
2.5.1. Paper-Based Instructions Method | The paper-based instructions were extracted from the manual of the piston pump that is used for troubleshooting and repair. For the two maintenance tasks, two paper-based instructions were designed and delivered on A4 sheets of paper, one page per step. Each step was composed of pictures, text information, and the needed tools. For the highly demanding task, the paper-based instructions consisted of 22 pages and 40 steps. The first page contained a list of all parts (disassembled) and their code numbers, as well as the objective of the task. Each of the following pages (page 2 to page 20) contained two of the 40 steps (see | PMC10536580 | ||
2.5.2. AR-Based Instruction Method | CAD | CAD | The first step in building the AR instructions was to create 1:1 CAD models for the piston pump using the SolidWorks software. After that, PTC Creo illustrate was used to build and edit the sequence animation for the AR experience. The 3D instructions for assembly, repair, and disassembly of the two tasks were created based on visual cues and animations. Step-by-step instructions were created using several motion effects (as applicable) for individual steps, such as fly-in/fly-out, fade-in/fade-out, shake, pulse, unscrew, etc. These effects were added to each step individually, and then all steps of one intended instruction were combined into one fluid motion. Also, other resources, such as animated hand tools like a screwdriver, wrench, arrow, and puller, were added. Then, the 3D instructions were published as a PLZ file to be imported by Vuforia Studio software to create the AR experience. Vuforia Studio is a web-based tool used to create and publish AR experiences and enables users to provide step-by-step work instructions and overlay 3D digital content on real-world equipment to provide contextual knowledge. In addition, the programming language JavaScript was used to develop the key features of the applications.Then, the created experiences for the maintenance tasks were published to the cloud-based “Vuforia Experience Service” with quick response (QR) codes and Things. Vuforia Experience Service represents a server used to store and deliver published AR experiences, which allow users to access them on Microsoft HoloLens 1 devices through the Vuforia View application. For displaying the AR instruction, the Vuforia View app stored on Microsoft HoloLens was used for scanning a specific Thing marker placed on the maintenance workplace 130 cm away from the participant. After the Thing Mark was identified, Microsoft HoloLens overlaid a 3D CAD model of the selected task on the user’s surroundings. In this method, the maintenance steps were presented as 3D animated models in the AR environment. The participants can interact with the 3D contents and control the playback of the animation by directing their gaze to the virtual buttons (e.g., play, next step, previous step, reset, name of tasks) placed above the 3D model and making a pinching gesture with their fingers. If the participant clicks the play button, a step-by-step animated sequence for the selected task is displayed. | PMC10536580 |
2.6. Cognitive Load Measurement | PMC10536580 | |||
2.6.1. Electroencephalography (EEG) Signal Response | muscle movements, blinks | BRAIN | To record the EEG signals, a standard protocol was followed to place the electrodes on the scalp based on the international 10–20 placement system [The EEG, EOG, and sternocleidomastoid EMG signals were acquired and amplified at a sampling rate of 1000 Hz with the help of a brain vision recorder system (Brain Products GmbH, Germany). The contact impedance between all electrodes and the skin was kept under 20 kΩ. Electrode impedances were adjusted before raw data collection by filling the electrodes with electrolyte gel. Electrolyte gel was applied by syringe to create a stable electrical connection between each electrode and the scalp. The raw EEG data contains artifacts that have non-neural origins and are usually the result of eye movements, eye blinks, jaw movements, and muscle movements. The recorded EEG signals were initially inspected visually for these suspicious artifacts and then preprocessed using EEGLAB [The EEG data were processed using wavelet packet analysis and decomposed using a six-octave wavelet, with the dB4 mother wavelet being chosen as the most appropriate function [ | PMC10536580 |
2.6.2. Subjective Response | For subjective workload, the NASA-TLX was utilized to assess participants’ perceived workload following each task on six dimensions (i.e., mental, physical, and temporal demands, performance, effort, and frustration) and the overall weighted workload [ | PMC10536580 | ||
2.7. Experimental Setup and Procedure | The study was conducted in the Industrial Engineering Department’s maintenance lab. The temperature, humidity, and light intensity at the center of the table in the laboratory were 21.4 °C, 18.2%, and 392.5 lux, respectively. The experimental zone was secure from vibrations or strong odors during the task’s execution. To attract participants, an announcement and invitation were issued and distributed at King Saud University. The participants were invited to participate in a pre-test session as well as two test sessions ranging from 1 to 4 h. Upon participant arrival, the purpose of the experiment was explained in detail, and the screening process was completed. The results of the health survey were reviewed and approved; if acceptable, the participant was asked to sign a consent form and fill out a demographic questionnaire. In addition, the participants were requested to provide background information and answer questions related to their existing AR experience. After that, their anthropometric data was collected.Next, participants were randomly assigned into two groups and given a briefing on how to use the instruction method assigned to their group. The first group received AR-based instructions, in which a Microsoft HoloLens1 was used to display relevant maintenance instructions and guide the participant to perform the maintenance tasks. In the AR-based instruction group, participants were given 10 to 15 min to familiarize themselves and learn how to handle, adjust, the HoloLens and interact with it [The participant returned to the lab the next day to perform the maintenance tasks with the help of the assigned instruction method from the previous day (AR-based or paper-based instructions). On this day, for example, participants in group 1 (the AR-based instruction group) were randomly assigned to perform the high- or low-demanding task with AR instructions. These tasks were randomly allocated to the participants in different sequences using a counterbalancing method to avoid the ordering effect of the tasks. The AB or BA sequences (A and B refer to high- and low-demanding tasks, respectively) were applied. In the AB sequence, half of the participants within group 1 were asked to perform a highly demanding task first (repairing a piston pump’s gearbox). The remaining participants were assigned to the BA sequence and were asked to perform the least-demanding task first. Two days later, participants returned to the lab to start the other half of the experiment, which is the task that was not performed in the first half (i.e., a low or high-demanding task), with AR instructions. Participants in group 2 (who used paper-based instructions) followed the same procedures as group 1.Before the performance of each training task, the EEG electrodes were placed on the participants’ skin. After that, three minutes of EEG signals were recorded at resting postures to be used as baseline data. During the training tasks, EEG signals were recorded. After the training tasks were completed, the signals were recorded again for three minutes, and the training time was recorded. Total training time is the time taken to complete the task while following the instructions. The camera system and stopwatch were used to record this time. Upon completing the task, the electrodes were removed, and the participants were requested to complete questionnaires to measure their subjective perception of the task and the technique of completing it in terms of perceived workload. | PMC10536580 | ||
2.8. Data Analysis | Statistical analyses were implemented using the SPSS Statistics software version 23.0 (IBM Corp, N.Y., USA). The significance level (type I error) was set to 0.05. The reliability of the statistical analysis was verified by checking the design assumptions of normality, homogeneity of variance, and continuity of data. To ensure that the normalcy assumption is true, a Kolmogorov-Smirnova test was performed [ | PMC10536580 | ||
3. Results | PMC10536580 | |||
3.1. Performance | The result of the mixed ANOVA revealed that there was a significant main effect of task complexity on the total training time ( | PMC10536580 | ||
3.2. Mental Workload | PMC10536580 | |||
3.2.1. Theta (θ) Power Spectrum Density | The statistical results shown in Further analyses were performed using paired | PMC10536580 | ||
3.2.2. Alpha (α) Power Spectrum Density | The instruction method was found to significantly affect α power at the frontal, central, parietal, occipital, and temporal regions (Further analyses were performed using paired | PMC10536580 | ||
3.2.3. Beta (β) Power Spectrum Density | The statistical results revealed that the main effect of the instruction method was statistically significant on β power for the central and occipital regions ( | PMC10536580 | ||
3.2.4. Perceived Workload (NASA-TLX) Scores | Perceived workload levels were assessed with the NASA-TLX workload questionnaire [ | PMC10536580 | ||
4. Discussion | The goal of this study was to find out how performance and cognitive workload are affected by different instruction methods (paper-based vs. AR-based instructions) and task complexity (high vs. low-demanding tasks) when using maintenance applications. Currently, monitoring the workload of AR system users is mainly subjective. Therefore, accurate and sensitive methodologies are required for assessing the workload of AR system users during maintenance operations. To the best of our knowledge, there are very few studies that integrate subjective and objective metrics to evaluate the mental workload of AR system users during maintenance operations. The work presented here focuses on how AR-based instruction methods with different levels of demanding tasks influence human performance and cognitive workload. The overall findings of this study mainly confirm the original hypotheses. | PMC10536580 | ||
4.1. Performance | User performance while using an AR instruction method was assessed against the paper instruction method using total training time. Maintenance training times varied significantly between tasks, with a significant increase from low-demanding to high-demanding regardless of instruction method type (i.e., a 50% increase). The training time for the high-demanding task was significantly higher than the low-demanding task in the AR-based instruction method (24.48 vs. 13.30 min) and the paper-based instruction method (28.76 vs. 13.36 min). Using AR instructions, the time was saved by 0.45% for the low-demanding task and 14.94% for the high-demanding task as compared to paper instructions. The study’s findings revealed that using AR-based instruction during high-demanding tasks significantly speeds up maintenance training when compared to paper-based instruction. It could be argued that paper-based instruction for this highly demanding task is time-consuming as it requires browsing papers and extracting different features. In contrast, the introduced AR-based instruction provides different functionalities that can be presented on demand (i.e., virtual and real contents). On the other hand, no advantage in training time was observed while using AR for the low-difficulty task with a small number of task steps. Thus, AR instructions showed great improvement in training time as the difficulty level increased.The findings of this study are in line with those in existing studies [ | PMC10536580 | ||
4.2. Mental Workload | The mental workload can be perceived as the ratio of available cognitive resources to external and task-related demands. The cognitive processes that are connected with mental workload begin with data reception and processing and end with motor response activation and motor pattern monitoring [ | PMC10536580 | ||
4.3. Perceived Workload (NASA-TLX) Scores | Compared to the AR-based instruction, the average physical workload, performance, and frustration ratings were significantly higher when the participants performed the high-demanding task using paper-based instruction. Utilizing the AR instruction technique for highly demanding tasks led to a reduction of 12.18% in physical workload, 8.69% for performance, and 60.14% for frustration. In addition, when the participants performed the low-demanding task using AR instruction as compared to paper-based instruction, the average temporal demand ratings were significantly higher and performance ratings were lower. Compared to the paper-based method, using AR instruction for the low-demanding task led to lower performance and frustration ratings by 27.64% and 24.97%, respectively, and more temporal demand by 43.63%. Overall, the AR-based instruction task was found to cause a reduction of 18.13% for performance, 50.82% for frustration, and 6.50% for overall mean scores. Also, the average mental and physical workloads and temporal and frustration ratings for the two instruction methods were found to increase as the task complexity increased.Previous research on the effect of AR tools on perceived workload and performance during training has yielded inconclusive results, with some researchers claiming that using AR to deliver visual guidance and task-relevant information reduced cognitive load and increased performance [ | PMC10536580 | ||
4.4. EEG Power Spectrum Density | HMD, visual with auditory) | EVENT | The results revealed that performing the high-demand maintenance task using AR instruction led to an increase in the theta power in the parietal region as compared to the low-demand task, but no change was detected between the high and low-demand tasks when participants used paper-based instruction. In addition, there was a significant change between paper-based and AR instructions while participants performed the most demanding task, but no significant difference was found between the least demanding tasks. The increased theta power at the parietal region, when the participants performed the highly demanding task using AR instruction, may be an indicator of attentional orienting to a task-relevant class of event. On the other hand, participants who performed the high- and low-demanding tasks using paper-based instruction used the same class of cues for processing the information. Related to α power, the findings revealed that for the AR method, the α power during the high-demanding task demonstrated significantly larger values than during the low-demanding task across all regions of interest. In addition, for paper-based instruction, the α power of the temporal and occipital regions for the high-demanding task increased significantly relative to the low-demanding task but remained approximately the same over the frontal, central, and parietal regions. The results showed that at a low-demanding task, the α power in the central region for AR groups was found to be significantly increased relative to paper-based instruction but not significantly increased in the parietal, frontal, temporal, and occipital regions. These increases in alpha power are possibly due to sensory inhibition or internal processing demands. The drastic increase in alpha power attributed to the execution of the mental demand during the AR experience is remarkable. When compared to paper-based instruction, β power was found to be reduced in the central and occipital regions during AR instruction. In addition, the β power values were found to decrease as task complexity increased for all regions of interest, no matter what the instruction methods used. The increase of theta and alpha and the decrease of beta have probably resulted from the perceived intrinsic load that participants interpret as the intricacy of the objective affordances concerning their abilities to handle the maintenance task (i.e., their prior knowledge). As the task load increases, so does the amount of resources used, and more of the available capacity is used [The findings of this study are in line with previous studies, which reported that θ and α activities may be associated with memory, cognition, and attention [The overall findings of this study revealed that the use of AR instruction caused an increase in mental workload. Such an increase could be interpreted as a more germane cognitive load, which is desirable as it is associated with learning new skills and other information. So, AR fosters the construction of schemata (GCL) and mental models by activating the cognitive processes of the participants and encouraging them to invest more effort in learning. The germane load during AR is increased due to incorporating new information, as well as the development and updating of schema, which takes up some of the memory [Furthermore, the increased mental workload during AR usage may arise from the fact that delivering AR instructions is a novel method and participants have to learn new interaction techniques, which activates the cognitive processes of the participants to invest more effort into learning, raising mental effort. Hence, using AR as an instruction method, participants could better facilitate long-term knowledge and skill acquisition, manage their working memory load, and learn successfully. During the AR instruction method, the information is processed in working memory and stored in long-term memory, and knowledge, in accordance with schema theory, is stored and arranged in the mind in the shape of schemata. Also, during AR, the participants spent a greater amount of their mental resources on processes that were irrelevant to the actual task, like repressing instruction through animation, visual cues, and arrows. To overcome this, it is preferable to show an instruction visually when put together with animation. While presented instruction combined with animation requires visual resources, auditory instruction uses the phonological system of working memory [The current study has some limitations that are worth noting. The design was limited to a standing posture. The participants were restricted to standing during the task performance. Therefore, the effects of different postures (e.g., sitting and standing) should be investigated in the future. Second, upper body kinematics were not monitored in this study. Tracking inter-individual kinematic differences may aid in explaining observed differences in stiffness responses to complex tasks and instruction methods. In addition, all participants were male students. Future works will include female and other physiological signals (i.e., autonomic nervous system and upper arm muscle activity). Moreover, the target users were also novices, so it would be better to recruit experienced participants or experts to make the evaluations and comparisons more complete. Furthermore, the range of the participants’ ages was quite narrow, so it would be interesting to do more research on a broader age group in the future. The results and conclusions of this study were reached in light of the particular interfaces utilized for this user study (visual cues with animation), and the usage of different variations of the interface (visual with auditory), technology (HMD, HHD), and research designs (between, within, or mixed design) may yield different results and conclusions. Finally, this study also illustrated very effectively that the benefits promised by AR for maintenance applications will not be realized automatically. | PMC10536580 |
5. Conclusions | This study evaluated the effects of instruction methods and task complexity on cognitive and perceived workloads in maintenance applications. The results supported the hypotheses that the AR method is more suitable, efficient, and effective to display maintenance instructions than the paper method; that AR instructions lead to faster maintenance times than paper instructions; and that AR instructions lead to a greater increase in mental workload than paper-based instructions, especially for the highly demanding task. Using AR instructions, the time was saved by 0.45% for the low-demanding task and by 14.94% for the high-demanding task as compared to paper instructions. It is argued that paper-based maintenance instruction for the highly complex task is time-consuming (i.e., viewing a paper and extracting different features). In contrast, the introduced AR-based instruction provides different functionalities that are presented on demand. Thus, the benefit of using AR for the low-difficulty task (with a small number of task steps) was relatively small. As the difficulty level increased, the advantages of applying AR to an instruction system became more obvious. Thus, in similar cases of higher task complexity, AR is recommended to be utilized. Furthermore, AR could enhance cognitive abilities to process information by easing information access and keeping working memory capacity free for use. Overall, the use of AR to guide workers through high-demanding maintenance tasks increased information processing, which could be connected to germane cognitive load due to learning. The findings suggested that AR instruction increased the germane cognitive load, which is the portion of cognitive load that assists in learning new skills and other information. AR for a high-demanding task allows for using cognitive or metacognitive prompts to hustle the participant in the right direction or to give the participant cues on how to best process the maintenance instructions. So, AR fosters the construction of schemata (GCL) and mental models by activating the cognitive processes of the participants to invest effort into learning, raising mental effort.Overall, this study shows that augmented reality should be used for high-demand maintenance tasks because it cuts down on maintenance time and makes it more likely that information will be stored in long-term memory and encrypted for later use. The results of this study can help manufacturing stakeholders better understand the benefits of AR technology as an instruction tool for manual tasks. Furthermore, the findings of this study could aid manufacturers of AR instruments in fine-tuning their products to overcome some of the limitations encountered. Also, the results of this study are important for the advancement of knowledge relative to cognitive workload evaluation while using AR systems in maintenance and assembly tasks. | PMC10536580 | ||
Author Contributions | Conceptualization, M.H.A. and M.Z.R.; Data curation, F.M.A. (Faisal M. Alessa) and M.H.A.; Formal analysis, M.H.A.; Funding acquisition, F.M.A. (Faisal M. Alessa); Investigation, M.H.A.; Methodology, F.M.A. (Faisal M. Alessa), M.H.A. and M.Z.R.; Project administration, M.H.A.; Resources, I.M.A.-h. and M.Z.R.; Supervision, F.M.A. (Faisal M. Alessa), I.M.A.-h. and M.Z.R.; Validation, F.M.A. (Faisal M. Alessa), M.H.A., I.M.A.-h., M.Z.R. and F.M.A. (Fahad M. Alqahtani); Writing—original draft, F.M.A. (Faisal M. Alessa) and M.H.A.; Writing—review & editing, M.H.A., I.M.A.-h., M.Z.R. and F.M.A. (Fahad M. Alqahtani). All authors have read and agreed to the published version of the manuscript. | PMC10536580 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Human Participants Review Subcommittee of the Institutional Review Board at King Khalid University Hospital, College of Medicine, King Saud University (protocol code E-19-4467 and date of approval 23 January 2020). | PMC10536580 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10536580 | ||
Data Availability Statement | All data supporting reported results are included in the manuscript. | PMC10536580 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10536580 | ||
References | NASA-Tlx | The gearbox and pump housing of the piston pump in a fully assembled state.Examples of the paper-based instructions for the highly demanding maintenance task (Gearbox of piston pump).Examples of the paper-based instructions for the low-demanding maintenance task (Pump housing).Samples of AR instruction for removing duo-piston during gearbox maintenance as viewed by Microsoft HoloLens.EEG, EOG, and EMG Electrodes placement.Average total training time for all levels of instruction methods and task complexity. Error bars represent a 95% confidence interval. Columns connected with lines and “*” marks are significantly different from each other.θ power for the parietal region for all levels of task complexity and instruction methods. Error bars represent a 95% confidence interval. Columns connected with lines and “*” marks are significantly different from each other.α power for (List of the maintenance steps for the high-demanding task (piston pump).List of the maintenance steps for the low-demanding task (pump housing).Mean (SD) and statistical results for θ, α, and β power of all regions of interest (i.e., Frontal, central, parietal, occipital, and temporal) across experimental tasks. Bolded Mean (SD) and statistic results for perceived workload (NASA-Tlx) scores across experimental tasks. Bolded | PMC10536580 | |
ABSTRACT | candidemia, candidiasis | CANDIDEMIA, CANDIDIASIS | Trial Registration: NCT04148287.The authors declare a conflict of interest. Jose A. Vazquez received grant support from Cidara, Scynexis and was a consultant for Cidara, Scynexis, F2G, Amplyx. Michael R. Hodges, Eric Ople, Pamela Wedel were employees of Amplyx (now a Pfizer Inc subsidiary). Michael R. Hodges was previously an employee of Pfizer and holds Pfizer stock. Paul A. Bien and Margaret Tawadrous are employees of Pfizer and hold Pfizer stock. Iwona Oborska was a consultant for Amplyx, previously a Pfizer employee, and Pfizer shareholder. Fathima Paruk has served on the speaker bureaus for Thermofischer Scientific, Pfizer, Biomerieux, MSD and Dr Reddy's. Peter G. Pappas received grant support from Astellas, Gilead, Mayne, Cidara, Scynexis and provided advisory and consultancy services to Amplyx, Mayne, Scynexis. Kenneth Boffard has no conflicts of interest to declare.Fosmanogepix (FMGX), a novel antifungal available in intravenous (IV) and oral formulations, has broad-spectrum activity against pathogenic yeasts and molds, including fungi resistant to standard of care antifungals. This multicenter, open-label, single-arm study evaluated FMGX safety and efficacy for treatment of candidemia and/or invasive candidiasis caused by | PMC10190264 |
KEYWORDS | PMC10190264 | |||
RESULTS | PMC10190264 | |||
Disposition, demographics, and exposure. | candidemia, death, ≤28 | CANDIDEMIA, ACUTE MYELOID LEUKEMIA | The study enrolled 9 participants from 2 sites in South Africa (15 participants were planned for enrollment). However, the study was terminated early due to the impact of the COVID-19 pandemic on patient enrollment. The intent-to-treat and safety populations each included all 9 enrolled participants with candidemia (henceforth, study population). Eight participants completed a full course of treatment, and one did not complete treatment due to death. Seven participants completed the study through the 4-week follow-up, with an additional death reported during the follow-up period.Demographics and baseline characteristics for enrolled participants were consistent with the epidemiology of Demographics and baseline characteristicsSD, standard deviation.yrs, years.BMI, body mass index.APACHE, acute physiology and chronic health evaluation.ICU, intensive care unit.The mean (SD) duration of treatment with FMGX was 19 (5.83) days, ranging from 11 to 27 days; most participants (5/9 [55.6%]) received FMGX for >14 days but ≤28 days. All participants received FMGX via IV infusion; none were switched to the oral formulation. PK sampling was sparse and relatively few PK samples were collected, precluding a model-based compartmental analysis. However, a linear, two-compartment population PK model-based on previous phase I studies provided an adequate fit for the MGX concentrations observed. The PK data collected indicated that all participants had systemic exposures to MGX (median [range] total drug plasma AUC over duration of therapy: 93 [64.4 to 182] mg·h/L), consistent with prior exposure data from Phase 1 and Phase 1b studies in healthy volunteers and in patients with acute myeloid leukemia. MGX AUC:MIC ratios were also determined (median [range] total drug plasma AUC:MIC ratio over duration of therapy: 7147 [5194 to 12112] mg · h/L). Attainment of the total-drug plasma AUC:MIC ratio ED | PMC10190264 |
MATERIALS AND METHODS | candidemia, candidiasis, hepatic impairment | HEPATIC IMPAIRMENT, CANDIDEMIA, CANDIDIASIS, STERILE | This multicenter, open-label, non-comparative, single-arm study (NCT04148287), evaluated the safety and efficacy of FMGX for the treatment of candidemia and/or invasive candidiasis caused by Eligible participants (males and females, ≥ 18 years of age) had an established diagnosis of candidemia and/or invasive candidiasis caused by Mycological and clinical diagnoses criteria were: ≥ 1 positive culture from blood or other normally sterile site for Exclusion criteria included severe or moderate hepatic impairment (total bilirubin > 3x upper limit of normal and alanine aminotransferase or aspartate aminotransferase > 5x upper limit of normal); concomitant use of strong CYP inhibitors; investigator-assessed life expectancy <7 days; diagnosis of | PMC10190264 |
Treatment. | infection, candidiasis | INFECTION, CANDIDIASIS, SECONDARY, ADVERSE EVENT | Participants were treated with FMGX within 12 h of study enrollment (Study Design. For participants with invasive candidiasis, maintenance dosing was to continue until there was at least 1 negative tissue culture or aspirate/fluid. For participants with a deep-seated site of infection from which a tissue culture was not obtainable, maintenance dosing was to continue until after the resolution of the attributable clinical signs of infection recorded at baseline, and as applicable, radiological improvement associated with the site of infection. BID, twice daily; EOST, end of study treatment; FMGX, fosmanogepix; IV, intravenous; PO, orally; QD, once daily.Plasma samples for pharmacokinetic (PK) analysis of FMGX and MGX levels were collected at baseline (pre-dose), twice weekly during treatment, at EOST/early termination (ET), and 2 weeks after EOST. Adverse events (AEs) were recorded from the date of informed consent through study completion, and coded (using Medical Dictionary for Regulatory Activities [MedDRA] version 22.0).The primary efficacy endpoint was the percentage of participants with DRC-assessed treatment success at EOST, defined as clearance of Secondary efficacy parameters included all-cause mortality through Day 30, and time to first negative blood culture. The DRC also assessed treatment success at 2 and 4 weeks after EOST. Investigator-assessed secondary parameters included percentage of participants with successful mycological outcomes, treatment success at EOST and 2 and 4 weeks after EOST, and the number of participants with TEAEs. | PMC10190264 |
Data availability. | Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See | PMC10190264 | ||
ACKNOWLEDGMENTS | We thank all investigators, staff, and patients for participating in study-related activities and procedures. Milli Kapoor (PhD, employee of Pfizer) assisted with The study was funded by Amplyx, now a subsidiary of Pfizer Inc.Jose Vazquez received grant support from Cidara, Scynexis and was a consultant for Cidara, Scynexis, F2G, Amplyx. Michel R Hodges, Eric Ople, Pamela Wedel were employees of Amplyx (now a Pfizer Inc subsidiary). Michel R Hodges was previously an employee of Pfizer and holds Pfizer stock. Paul A. Bien and Margaret Tawadrous are employees of Pfizer and hold Pfizer stock. Iwona Oborska was a consultant for Amplyx, previously a Pfizer employee, and Pfizer shareholder. Fathima Paruk has served on the speaker bureaus for Thermofischer Scientific, Pfizer, bioMérieux, MSD and Dr Reddy's. Peter Pappas received grant support from Astellas, Gilead, Mayne, Cidara, Scynexis and provided advisory and consultancy services to Amplyx, Mayne, Scynexis. Kenneth Boffard has no conflicts of interest to declare. | PMC10190264 | ||
REFERENCES | PMC10190264 | |||
Background | weight gain, GDM | GDM, GESTATIONAL DIABETES MELLITUS | Previous studies have demonstrated that excessive gestational weight gain (GWG) increases the risk of gestational diabetes mellitus (GDM). This study aimed to determine the effect of using health coaching on the prevention of GDM in overweight pregnant women. | PMC10664614 |
Methods | GDM, overweight, gestational diabetes | GDM, SECONDARY, GESTATIONAL DIABETES | In this quasi-experimental study, 64 eligible overweight women at 12–14 gestational weeks were randomly divided into 2 groups: the coaching group and the control group (usual care group). The intervention group received 8 weeks of the phone coaching program, which integrated GWG and physical activity to reduce the incidence of GDM. The Pregnancy Physical Activity Questionnaire (PPAQ) was used to assess physical activity during pregnancy. The occurrence of gestational diabetes was determined based on the 75-g 2-hour oral glucose tolerance test (OGTT) at 24–28 weeks of gestation. The primary outcome was the incidence of GDM, and the secondary outcomes included physical activity, GWG, and neonatal and maternal birth outcomes. | PMC10664614 |
Results | GDM | GDM | The incidence of GDM in the control and intervention groups was 24.1% and 22.6%, respectively. The relative risk (RR) was 0.93 (95% CI, 0.37–2.34; | PMC10664614 |
Conclusions | gestational diabetes | GESTATIONAL DIABETES | The findings and implications of this research could significantly contribute to maternal health and gestational diabetes prevention. Additional support from a midwife coach resulted in better GWG. More studies are needed to assess the impact of health coaching as a component of usual care and its long-term effect on maternal and neonatal outcomes. | PMC10664614 |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12905-023-02750-0. | PMC10664614 | ||
Keywords | PMC10664614 | |||
Background | GDM | GDM, GESTATIONAL DIABETES MELLITUS, DISEASES | Gestational diabetes mellitus (GDM) is a condition that involves impaired glucose and carbohydrate metabolism during pregnancy [Nowadays, different interventions are used to prevent GDM, including lifestyle changes [Health coaching is a unique approach that can widely improve health behaviors in patients with chronic conditions and is a tool to change unhealthy behaviors that lead to preventable diseases [ | PMC10664614 |
Methods | weight gain, GDM, gestational diabetes | GDM, COMPLICATIONS, GESTATIONAL DIABETES | This study was conducted between April 2022 and November 2022 at 2 obstetrics and gynecology clinics in Babol City, Iran. The Research Ethics Committee of Babol University of Medical Sciences approved this study (code: IR.MUBABOL.REC.1401.016).Inclusion criteria were a pre-pregnancy BMI of 25 kg/mA sample size of 32 in each group was calculated based on, a 50% reduction in the incidence of gestational diabetes with significance level (alpha) of 0.05 (two-tailed) and 80% statistical power by G-power software [Of the 92 eligible pregnant women referred to the clinics, 28 were excluded according to exclusion criteria. In total, 64 women signed the written informed consent form. The women were randomly assigned to 2 groups: the usual care group and health coaching intervention group (1:1) according to the block of 4 using computer-generated random numbers. However, in a quasi-experimental design, true randomization may not be feasible due to various constraints and ethical considerations, but this study had the rationale for using a quasi-experimental design based on the existing literature, ethical considerations factors. In addition, due to the intervention methods of the 2 groups, blinding was not feasible, and the study was open-label. The dropout of the study was 6.3% (1 subject in the intervention group and 3 subjects in the control group; Fig.
Consort fellow diagram of the participantsBoth groups received standard prenatal care to ensure the safety of the mother and fetus, including risk assessment, physical examination, patient education, health promotion, and therapeutic intervention by 2 attending obstetricians. In the intervention group, in addition to standard prenatal care, 4 telephone call-based coaching sessions were conducted every 2 weeks (16–22 weeks of pregnancy), and each session lasted 30–45 min by a midwife coach (undergraduate midwife coach); however, it is important to note that standard prenatal care was not provided during the coaching sessions.The health coaching protocol is based on the GROW (Goals, Reality, Options, and Will) coaching model to help pregnant women define their goals. In each session, the participant gave personal feedback on their nutrition and exercise habits during the last 5 days. Briefly, the goals of the coaching sessions include (1) promoting a positive attitude through education and skill development, (2) providing verbal and written access to evidence-based information about lifestyle (how to control weight and how to gain ideal weight during pregnancy and undertake at least 30 min of moderate regular exercise 3 to 4 days a week), (3) minimizing dangerous lifestyles and consume evidence-based healthy diets (such as fruits, high-fiber, whole-grain products, and vegetables), (4) optimizing weight control management, (5) problem-solving methods and activity planning, and (6) promoting active monitoring of weight gain during pregnancy and considering it important in preventing complications, including GWG.All participants with a BMI of 30 kg/mDuring the intervals between coaching sessions, the intervention group received short messages on various topics, such as recording weight changes, encouraging goal achievement, re-emphasizing positive lifestyle changes, and encouraging self-evaluation of the situation. Throughout the study, the participants were encouraged to identify obstacles to achieving their goals and to develop strategies to overcome them, with the help of the coaching program. This approach enabled them to make positive changes in their lifestyle and successfully achieve their weight management goals.The primary outcome was the incidence of GDM for both groups. Diagnosis of GDM was made based on at least 1 abnormal value report of glucose 2 h after 75-g oral glucose tolerance test (OGTT) at 24–28 gestation weeks, and a fasting glucose (0 h) value ≥ 92 mg/dL, 1-hour ≥ 180 mg/dL, or 2-hour ≥ 153 mg/dL (2011) [Baseline socio-demographic and clinical characteristics were collected at enrollment using a checklist. Anthropometric measurements and physical activity levels of all participants were collected at both baseline and after the intervention period using the Pregnancy Physical Activity Questionnaire (PPAQ) and anthropometry measurements. Data on maternal and neonatal outcomes and birth weight were obtained from the medical records of the women. Finally, participants were asked about their experience with phone health coaching during pregnancy.PPAQ is a standard self-reported questionnaire devised by Taber et al. for assessing physical activity of pregnant women [The participant’s weight was measured using a Seka scale (Germany) without shoes and with minimal clothing and an accuracy of 100 g. The measurements were taken at the initial antenatal visit (baseline) and again at 24 to 28 weeks. Height was measured using an inflexible tape measure mounted on the wall with an accuracy of 1 cm. Measurements were taken without shoes in a standing position with their heels attached to the wall and looking forward. The weight gain was changes in weight from baseline to 24–28 weeks gestation and also changes from baseline to birth. The body mass index was calculated using the formula of weight in kilograms divided by the square of the body height in meters, in accordance with the definition of the World Health Organization. | PMC10664614 |
Statistical analyses | GDM | GDM, REGRESSION | SPSS version 22 (SPSS Inc., Chicago, IL., USA) was used for statistical analysis. The normality of data was tested using the Shapiro-Wilk W test, and continuous variables had a normal distribution. Descriptive statistics were used to describe continuous variables, and frequency distributions were used for categorical variables. To ensure the desirability of the random allocation process, the basic variables of the participants were checked in both groups after collecting the data in the first stage. The effect of health coaching during the follow-up period on GDM (each inappropriate glucose value) was expressed by calculating the relative risk (RR) at 95% CI. A multiple regression approach for analysis of covariance (ANCOVA) was used to assess the differences in physical activity and GWG between the pre-trial and post-trial phases in the 2 groups with controlling the effect of variables such as age, pre-pregnancy weight, and pre-pregnancy BMI as a covariate.Also, we used chi-square and Student | PMC10664614 |
Discussion | GDM among overweight, gestational diabetes, polycystic ovary syndrome, GDM, overweight, preterm labor, preeclampsia | OBESE, GESTATIONAL DIABETES, POLYCYSTIC OVARY SYNDROME, GDM, PRETERM LABOR, TYPE 2 DIABETES, PREECLAMPSIA | This quasi–experimental study investigated the effectiveness of an 8-week phone coaching program, which integrated GWG and physical activity, in reducing the incidence of GDM in overweight or obese pregnant women. The program was delivered by a midwife coach through 4 telephone sessions, each lasting 30–45 min. However, the study found that the program did not result in a significant reduction in the incidence of GDM when compared to the control group. However, the intervention group reported high satisfaction with phone health coaching during pregnancy. This intervention focused on promoting a healthy diet during pregnancy, GWG, and moderate regular exercise throughout pregnancy to prevent GDM. Most published studies used the health coaching intervention to control and treat type 2 diabetes and GDM [Our findings are consistent with those of a meta-analysis that included 23 studies with a total of 8,877 overweight or obese women aimed to prevent GDM. According to this meta-analysis, the physical activity and/or diet interventions (alone or in combination) were less effective than placebo in reducing the risk of GDM [There are several potential explanations for the lack of significant effects of our intervention on the prevention of GDM among overweight or obese women. A meta-analysis [In our study, maternal and neonatal outcomes were desirable in both groups, with no adverse outcomes. Only 2 cases of low birth weight and preterm labor were observed in the control group. In both groups, the cesarean delivery rate was almost equal. In the intervention group, there were 2 cases of normal vaginal birth after cesarean section. A Cochrane review of 15 trials found no evidence of a difference between the control and lifestyle intervention groups in maternal outcomes, such as cesarean section and preeclampsia in treating women with GDM [There are some limitations in this study. First, this study used a non-probability sampling method, while future studies that use random sampling can provide stronger evidence on this intervention. Second, this study had a single-center design with a short intervention. Third, risk factors of gestational diabetes are varied so the risk factors can affect the incidence of gestational diabetes in our participants; however we considered the gestational diabetes risk factors in our exclusion criteria and excluded women with a higher risk of gestational diabetes. We suggest future studies consider having polycystic ovary syndrome of participants and dietary pattern of pregnant women. Moreover, further studies with longer interventions that include both the first and second trimesters of pregnancy can provide more relevant results. According to a meta-analysis, the prevention of GDM in overweight or obese pregnant women may require interventions that target both the first and second trimesters of pregnancy. Third, we did not assess compliance with a healthy dietary pattern, which will impact the association of the coaching intervention with GDM; however, our coaching intervention aimed to promote a healthy diet that supports both GWG and the prevention of GDM, as this was a key goal of the coaching sessions. Finally, participants in the control group might have taken information on physical activity and control weight from the participants in the intervention group, which might cause a confirmation bias. | PMC10664614 |
Conclusions | GDM, gestational diabetes | GDM, GESTATIONAL DIABETES | Despite the limitations, the findings implications of this research could significantly contribute to maternal health and gestational diabetes prevention. We showed that additional support from a midwife coach resulted in better GWG, but it did not affect the prevention of GDM. Considering that a few studies have been conducted to investigate the effect of health coaching on GDM, it is recommended to assess the impact of health coaching as a component of standard prenatal care, as well as to assess GDM and its long-term effects on maternal and neonatal outcomes. | PMC10664614 |
Acknowledgements | We acknowledge all participating pregnant women for taking part in this study. The authors thank professionals of two obstetrics and gynecology clinics in Babol City, Iran for assistance our study. We also greatly appreciate of Babol University of Medical Sciences in supporting of this work. | PMC10664614 | ||
Authors’ contributions | SE, FM | MAD, FM, FB, and AA designed the study. FM, AA, and SE had main responsibility for data collection. MAD and FM were major contributors for analyses, interpretation of the data, and drafted the manuscript. All authors reviewed the manuscript and approved the final draft. | PMC10664614 | |
Funding | This study was supported by Babol University of Medical Sciences. [grant number: 724134023). | PMC10664614 | ||
Data Availability | All data generated or analyzed during this study are included from preliminary studies are available from the corresponding author on reasonable request. | PMC10664614 | ||
Declarations | PMC10664614 | |||
Informed consent | Informed consent was obtained from all individual participants included in the study. | PMC10664614 | ||
Ethics approval and consent to participate | The study was reviewed and approved by the ethics committee of Babol University of Medical Science (Ethic ID: IR.MUBABOL.REC.1401.016). All the participants signed written informed consent forms. This study was conducted in accordance with the 1964 Declaration of Helsinki guidelines. | PMC10664614 | ||
Consent for publication | Consent for Publication as “NOT APPLICABLE”. | PMC10664614 | ||
Competing interests | The authors have no conflicts of interest relevant to this article. | PMC10664614 | ||
List of abbreviations | weight gainGestational diabetes mellitusPregnancy | Gestational weight gainGestational diabetes mellitusPregnancy Physical Activity QuestionnaireOral glucose tolerance testRrelative riskNeonatal intensive care unitBody mass indexInstitute of Medicineanalysis of covariance | PMC10664614 | |
References | PMC10664614 | |||
Introduction: | dysphagia, swallowing dysfunction, HNC, head and neck cancer, Dysphagia | DYSPHAGIA, DYSPHAGIA, HEAD AND NECK CANCER | Dysphagia is often caused by radiotherapy (RT) in patients with head and neck cancer (HNC), and reduced tongue pressure (TP) is often associated with swallowing dysfunction in the oral stage. However, the evaluation of dysphagia by measuring TP has not yet been established in HNC patients. Herein, we conducted a clinical trial to evaluate the usefulness of TP measurement using a TP-measuring device as an objective indicator of dysphagia induced by RT in HNC patients. | PMC10313278 |
Methods and Analysis: | dysphagia, oropharyngeal or hypopharyngeal cancer | DYSPHAGIA, SECONDARY | This ELEVATE trial is a prospective, single-center, single-arm, non-blind, non-randomized trial to evaluate the usefulness of a TP measurement device for dysphagia associated with the treatment of HNC. Eligible participants include patients with oropharyngeal or hypopharyngeal cancer (HPC) undergoing RT or chemoradiotherapy (CRT). The TP measurements are conducted before, during, and after RT. The primary endpoint is the change in the maximum TP values from before RT to 3 months after RT. Moreover, as secondary endpoints, the correlation between the maximum TP value and the findings of video-endoscopic and video-fluoroscopic examinations of swallowing will be analyzed at each evaluation point, as well as changes in the maximum TP value from before RT to during RT and at 0, 1, and 6 months after RT. | PMC10313278 |
Discussion: | dysphagia | DYSPHAGIA | This trial aimed to investigate the usefulness of evaluation by measuring TP for dysphagia associated with HNC treatment. We expect that an easier evaluation for dysphagia will improve rehabilitation programs for dysphagia. Overall, we expect this trial to contribute to the improvement of patients’ quality of life (QOL). | PMC10313278 |
1. Introduction | dysphagia, tumor, damages, cancer, sarcopenia, HNC, head and neck cancer, neurological diseases, Dysphagia | DYSPHAGIA, TUMOR, NEUROLOGICAL DISEASE, ADVERSE EVENTS, CANCER, SARCOPENIA, FUNCTIONAL DISORDERS, HEAD AND NECK CANCER, DYSPHAGIA | Earlier, surgery was the mainstay of treatment for head and neck cancer (HNC); however, treatment algorithms have changed to include postoperative or definitive chemoradiotherapy (CRT).While the number of cancer survivors is increasing, they often suffer from functional disorders, and their quality of life (QOL) declines after treatment.The normal swallowing process is generally classified into oral, pharyngeal, and esophageal stages according to the location of the bolus.Radiotherapy (RT) is an important treatment modality for HNC; however, it damages the tumor as well as healthy oral and pharyngo-laryngeal tissues. Dysphagia is developed in approximately half of the patients with HNC as acute and late adverse events (AEs) by RT.The usefulness of TP measurement has recently been demonstrated in evaluating swallowing function in patients with neurological diseases and sarcopenia.In this trial, we aim to investigate the usefulness of the TP measurement device as a quantitative evaluation method for dysphagia in HNC patients. Our findings will help improve rehabilitation programs for dysphagia and contribute to the improving the QOL of patients. | PMC10313278 |
2. Methods | PMC10313278 | |||
2.1. Study design | dysphagia, VF, cancer, hypopharyngeal, oropharyngeal, Cancer | DYSPHAGIA, CANCER, ADVERSE EVENT, CANCER | This clinical trial, currently ongoing at Nara Medical University Hospital, is a prospective, single-center, single-arm, non-blind, non-randomized clinical trial involving patients with oropharyngeal (OPC) or hypopharyngeal (HPC) cancer who undergo CRT or RT as the standard cancer treatment. Participants will undergo rehabilitation for dysphagia (RD) and several examinations, including TP measurement, VE, VF, cervical computed tomography, ultrasound examination, blood test, chest radiography, electrocardiogram, and respiratory function test. Moreover, AEs will be evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0, as proposed by the National Cancer Institute. | PMC10313278 |
2.2. Inclusion criteria | ONCOLOGY | Patients with OPC or HPC who underwent CRT or RT as primary treatment, including those who underwent neoadjuvant chemotherapy before CRT or RT.Age range: 18 to 85 years (regardless of gender).Eastern Cooperative Oncology Group performance status of 0 or 1.Patients who have provided written informed consent to participate in this study by themselves or through their surrogates. | PMC10313278 | |
2.3. Exclusion criteria | dysphagia, tooth, ’ | DYSPHAGIA, DISEASE | Patients who cannot understand the investigators’ indications.Patients who cannot maintain the TP probe in an appropriate position using their front tooth.Patients who are unable to apply pressure on the TP probe.Patients with dysphagia caused by past treatment for HNC.Patients with severe dysphagia due to a history of central system disease.Patients who are deemed unsuitable as research subjects by the investigator. | PMC10313278 |
2.4. Discontinuation criteria | CANCER PROGRESSION | Patients whose TP is difficult to measure due to other conditions (cancer progression and/or AEs) during or after treatment.Patients who decline study participation.Patients who avail the offer to withdraw consent.Patients who do not meet the eligibility criteria after registration.Patients who are unable to come to the hospital due to relocation or other reasons.The entire study is discontinued.The study has been discontinued for other reasons that the investigators deemed appropriate. | PMC10313278 | |
2.5. Protocol of intervention | SECONDARY | CRT or RT is the primary treatment for patients with OPC or HPC. However, concurrent chemotherapy regimens are not regulated. Adjuvant therapies, such as chemotherapy and secondary treatment using immune checkpoint inhibitors, are acceptable if needed. | PMC10313278 | |
2.5.1. Method of TP measurement. | TONGUE | After the participants are fully informed, TP is measured 3 times at each evaluation point by a TP measurement device (JMS Tongue pressure measurement device. JMS Co., Ltd.), and the maximum TP values are recorded. After treatment, the change in TP value is analyzed. If TP measurement is impossible, it is recorded as “Impossible” accompanied by a description of the reason. | PMC10313278 | |
2.5.2. Data collection. | Patient data will be collected before, during, and after RT, and at 0, 1, 3, and 6 months after the final date of RT (Table Overview of observation, clinical examination, and evaluation.“Before RT (Baseline)” is defined as the date between the acquisition of written informed consent and the beginning of RT. “During RT” is defined as the date between 1 month ± 7 days after the first day of RT. “0 months after RT” is defined as the date from the final day of RT to 7 days after that. “1 month after RT” is defined as the date between 1 month ± 7 days after the final day of RT. “3 months after RT” is defined as the date between 3 months ± 14 days after the final day of RT. “6 months after RT” is defined as the date between 6 months ± 14 days after the final day of RT. | PMC10313278 | ||
2.5.3. Evaluation of VE. | epiglottis | VALLECULA | The findings of the VE will be evaluated by the Hyodo score.The Hyodo score is defined as follows:The salivary pooling degree at the vallecula and piriform sinuses.No poolingPooling at the only vallecular.Pooling in the vallecula and piriform sinuses, but no penetration into the larynx.Pooling in the vallecula and piriform sinuses and penetration into the larynx.The glottal closure reflex induced by touching the epiglottis or arytenoid.Marked reflex by 1 touch.Slow and/or weak reflex by 1 touch.Reflex by 2 or 3 touches.No reflex despite several touches.The location of the bolus at the swallowing reflex initiation as assessed by “white-out” timing.Pharyngeal.Vallecula.Piriform sinuses.No swallowing reflex.The extent of pharyngeal clearance after blue-dyed water is swallowed.No residue.Pharyngeal residues remain but are absent after 2 or 3 swallows.Pharyngeal residues remain but there is no penetration into the larynx.Pharyngeal residues remain and there is penetration into the larynx. | PMC10313278 |
2.5.4. Evaluation of VF. | VF, Esophageal stage, expectoration | ASPIRATION, DISEASES, TRANSITION, TONGUE, SOFT PALATE | The evaluation of the VF has not yet been established. The VF findings will be described from the perspective below.Oral stage.The contrast medium is kept in oral.Transition of the contrast medium from oral to pharyngeal.Pharyngeal stage.Soft palate elevation and velopharyngeal function.The residual of the contrast medium at the vallecula and piriform sinuses.Aspiration and expectoration.Laryngeal elevation.Laryngeal closure.Pharyngoesophageal Segment Opening.Tongue Base Retraction.Esophageal stage.Esophageal clearance and peristalsis.Counterflow in the esophagus.Diseases of and around the esophagus. | PMC10313278 |
2.5.5. Rehabilitation for dysphagia. | The participants will undergo RD to prevent or recover from functional decline in swallowing. RD was routinely scheduled as a protocol intervention during RT. The patients underwent the rehabilitation program in the morning and evening as follows:Ice massage of the oral region (5 sets).Chin push-pull maneuver (10 seconds, 10 sets).Walking (3 minutes). | PMC10313278 | ||
2.6. Endpoints | PMC10313278 | |||
2.6.1. Primary endpoint. | The primary endpoint was the change in maximum TP value from baseline to 3 months after RT. | PMC10313278 | ||
2.6.2. Secondary endpoint. | VF | SECONDARY | The secondary endpoints are listed as follows:Changes in the maximum TP value from baseline to during RT as well as at 0, 1, and 6 months after RT. We performed the same analysis for the primary endpoint for each evaluation time.The findings of VE by the Hyodo score at each evaluation point.The findings of VF at each evaluation point. | PMC10313278 |
2.7. Sample size consideration | The study aims to enroll 40 patients with OPC or HPC who will be treated with CRT or RT over 4 years. The target number of cases was set based on feasibility, given that approximately 12 patients are treated annually with these therapies at the institution. If the average ± SD expected to change in the primary endpoint maximum TP is estimated to be 15.0, the width of the 95% confidence interval (CI) will be appropriately 4.0 ± 2.0 based on a previous study. | PMC10313278 | ||
2.8. Statistical analysis | SECONDARY | The “Full Analysis Set” is defined as the population that excludes study participants for whom no data on the maximum TP value are available. Analyses of the primary and secondary endpoints will be performed using the full analysis set.All analyses will be performed after the data for all endpoints have been collected, reviewed, and fixed. | PMC10313278 | |
2.8.1. Primary endpoint. | The average and 95% CI of the changes in the maximum TP value from baseline 3 months after RT will be analyzed as the primary endpoint. Moreover, the ratio of patients with “Impossible” will be calculated. | PMC10313278 | ||
2.8.2. Secondary endpoint. | dysphagia, VF, Dysphagia | DYSPHAGIA, SECONDARY, DYSPHAGIA | The average and 95% CI of the changes in the maximum TP value from baseline during RT, as well as 0, 1, and 6 months after RT will be analyzed as secondary endpoints. The ratio of patients with “Impossible” will be calculated as well.The change in the Hyodo score between the baseline and each evaluation point will be analyzed. The averages and 95% CI for the changes will be calculated. Moreover, the scatterplot and Pearson correlation coefficient between the Hyodo score and maximum TP value will be calculated.Dysphagia was evaluated based on the findings of VF at each evaluation point and the ratio of dysphagia among all participants, and the 95% CI of that will be calculated. Moreover, for participants in the group with dysphagia, the average and the 95% CI of both the maximum TP values and Hyodo score will be calculated.For all the above endpoints, subgroup analyses will be conducted by subject characteristics (e.g., background information) to explore factors that may be useful in determining future research and treatment strategies. | PMC10313278 |
2.9. Interim analysis and monitoring | No interim analysis will be scheduled for this trial. However, the trial will be monitored by independent conductors to ensure that it is being conducted safely and in accordance with the protocol and that the data are being collected accurately. An audit will be conducted if the monitoring reveals significant violations of relevant rules and regulations or deviations from the protocol. | PMC10313278 | ||
3. Discussion | dysphagia, VF, muscle damage, HNC | DYSPHAGIA | The primary objective of this trial was to evaluate the usefulness of the TP measurement device for dysphagia in patients with HNC. The tongue plays a significant role in the oral stage of swallowing, and a decrease in TP may result in dysphagia.In clinical practice, VE and VF are usually performed to evaluate dysphagia, and their utility has been established.In this trial, we evaluated the changes in TP affected by RT, since muscle damage by RT has already been reported and decreased TP could result in dysphagia in HNC patients.Measuring TP as a new method for evaluating swallowing function in HNC patients can provide several benefits. Firstly, the evaluation of swallowing function by measuring TP will enable the reduction of patient burden because the method of TP measurement is noninvasive, simpler, and safer than the VE and VF methods. Also, it allows easy assessment of swallowing function anywhere without the need for endoscopy or an X-ray device. Secondly, the TP measurement device provides objective and quantitative data that can be easily shared with medical staff to determine the extent of a patient dysphagia. Thirdly, objective swallowing data also helps in evaluating the effectiveness of RD. We expect that an easier evaluation of RD effectiveness will improve rehabilitation programs for dysphagia.Overall, we expect this trial to contribute to the improvement of patients’ QOL. | PMC10313278 |
Acknowledgments | We thank the staff of the Department of Otolaryngology-Head and Neck Surgery of Nara Medical University and the Institute for Clinical and Translational Science of Nara Medical University Hospital, especially Masahiro Isogawa, for assisting in refining the protocol. | PMC10313278 | ||
Abbreviations: | dysphagia, head and neck cancer | DYSPHAGIA, HEAD AND NECK CANCER, RECRUITMENT | adverse eventsconfidence intervalchemoradiotherapyhead and neck cancerhypopharyngeal canceroropharyngeal cancerquality of liferehabilitation for dysphagiaradiotherapytongue pressurevideo endoscopyvideo fluoroscopyThe datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.The results of this trial will be disseminated in peer-reviewed scientific journals and conference presentations.The study began in April 2022. Patient recruitment has not yet been completed, and the intervention program is ongoing. The follow-up and data collection will be completed in December 2025. The results are expected in December 2026.Ethical issues and consent to participate: This trial was reviewed and approved by the Nara Medical University Certified Review Board (CRB5200002) in March 2022. The trial was registered with the Japan Registry of Clinical Trials (jRCTs052220011). All investigators involved in this trial complied with the Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects and the Clinical Trials Act of the Ministry of Health, Labor and Welfare in Japan. The investigators provided a sufficient explanation of the trial. All the patients provided written informed consent to participate in this study.The authors declare that this study was funded by JMS Co., Ltd. Moreover, this study is supported by the Clinical Research Promotion Program grant from Nara Medical University (Project ID: JHR2100008).The authors have no conflicts of interest to disclose.How to cite this article: Tanaka A, Uemura H, Kimura T, Nishimura A, Aoki K, Otsuka S, Ueda K, Kitahara T. Evaluation of usefulness of tongue pressure measurement device for dysphagia associated with treatment of patients with head and neck cancer (ELEVATE). Medicine 2023;102:26(e33954). | PMC10313278 |
References | PMC10313278 | |||
Background | diabetes, Diabetes | DIABETES, SHIGA, TYPE 2 DIABETES, DIABETES | Edited by: Celestino Sardu, University of Campania Luigi Vanvitelli, ItalyReviewed by: Yukihiro Fujita, Shiga University of Medical Science, Japan; Nigusie Gashaye Shita, Debre Markos University, EthiopiaThis article was submitted to Clinical Diabetes, a section of the journal Frontiers in EndocrinologyLaughter has been reported to have various health benefits. However, data on the long-term effects of laughter interventions on diabetes are limited. This study aimed to investigate whether laughter yoga can improve glycemic control among individuals with type 2 diabetes. | PMC10102335 |
Methods | TYPE 2 DIABETES | In a single-center, randomized controlled trial, 42 participants with type 2 diabetes were randomly assigned to either the intervention or the control group. The intervention consisted of a 12-week laughter yoga program. Hemoglobin A1c (HbA1c), body weight, waist circumference, psychological factors, and sleep duration were evaluated at baseline and week 12. | PMC10102335 | |
Results | Intention-to-treat analysis showed that participants in the laughter yoga group experienced significant improvements in HbA1c levels (between-group difference: −0.31%; 95% CI −0.54, −0.09) and positive affect scores (between-group difference: 0.62 points; 95% CI 0.003, 1.23). Sleep duration tended to increase in the laughter yoga group with a between-group difference of 0.4 hours (95% CI −0.05, 0.86; | PMC10102335 | ||
Conclusions | TYPE 2 DIABETES | A 12-week laughter yoga program is feasible for individuals with type 2 diabetes and improves glycemic control. These findings suggest that having fun could be a self-care intervention. Further studies with larger numbers of participants are warranted to better evaluate the effects of laughter yoga. | PMC10102335 | |
Clinical trial registration | PMC10102335 | |||
Introduction | diabetes, Diabetes | DIABETES, TYPE 2 DIABETES, DIABETES | Diabetes is a chronic condition that requires lifelong self-management for metabolic control, such as healthy eating, regular physical activity, and self-monitoring of the blood glucose levels, as well as taking medication as prescribed (Previous studies have also found that individuals with type 2 diabetes had poor adherence to exercise and a healthy diet (In this study, we focused on laughter as an enjoyable diabetes self-care intervention. Laughter has been demonstrated to have various health benefits, such as reducing stress (We previously reported that the combination of laughter and exercise decreased hemoglobin A1c (HbA1c) levels among older adults (Laughter yoga is now used in many countries (Therefore, this 12-week randomized controlled trial investigated the effects of laughter yoga on glycemic control and psychological well-being in individuals with type 2 diabetes. | PMC10102335 |
Materials and methods | PMC10102335 | |||
Study design and participants | Diabetes | TYPE 2 DIABETES, DIABETES | This study was a single-center, two-group, randomized controlled trial designed to evaluate the effects of laughter yoga on individuals with type 2 diabetes. The intervention was conducted at Osaka University from October 2015 to December 2015. The study protocol was approved by the Scientific Ethics Committee of Fukushima Medical University (no. 2028). The Declaration of Helsinki was followed, and reporting in this article is aligned with the Consolidated Standards of Reporting Trials standards. All participants provided oral and written informed consent. This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry (no. UMIN000047164).Participants were recruited at the Diabetes Center of Osaka University Hospital, between August 2015 and September 2015. Three diabetologists evaluated their outpatients for study eligibility and approached patients meeting the eligibility criteria. Eligible patients received a flyer and the study was explained. Patients were recruited in order of their visit until the number of participants reached the target sample size. The inclusion criteria were outpatients aged 40 years or older with type 2 diabetes, HbA1c levels ranging from 6.1% to 7.9%, and changes in HbA1c levels < 1.0% during the last 3 months before baseline measurements. The glycemic control target is set at HbA1c <7.0% in Japan and modification of treatment (including intensive pharmacotherapy or insulin treatment) is needed when HbA1c level exceeded 8% (Before randomization, the participants were informed that similar laughter yoga sessions would be held after the study period for those who were allocated to the control group to reduce the reporting bias. | PMC10102335 |
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