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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 pa... | 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... | 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 ... | 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 instr... | 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 need... | 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 ... | 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 ... | 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. ... | 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. T... | 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 subj... | 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).... | 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 phy... | 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 ... | 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... | 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.; Supervisi... | 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... | 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 previo... | 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 (he... | 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 candidias... | 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 no... | 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, Scy... | 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 inci... | 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 m... | 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 c... | 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... | 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 v... | 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... | 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 ... | 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 clinic... | 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 chemoradioth... | 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) declin... | 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 r... | 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 participa... | 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... | 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 th... | 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 “... | 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”... | 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 piri... | 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 med... | 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 secon... | 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 e... | 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... | 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,... | 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 a... | 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 violatio... | 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 dysphagi... | 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... | 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 bee... | 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... | 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 la... | 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 ad... | 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 Fukus... | PMC10102335 |
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