Non-randomized Design Research Articles

Bimanual Arm Trainer Versus Traditional Occupational Therapy Services in Upper Extremity Function.

Upper extremity (UE) dysfunction resulting from stroke significantly affects a person's ability to complete self-care activities, consequently diminishing functional independence. Effective interventions that improve UE function in persons with stroke are needed. To explore the effectiveness of the Bimanual Arm Trainer (BAT) compared with traditional occupational therapy treatment sessions (i.e., a control group) on improving UE function after acute ischemic stroke. Clinical trial, two-group, nonrandomized repeated-measures design. Inpatient rehabilitation facility. Twenty-seven persons with ischemic stroke and an Action Research Arm Test (ARAT) score ≤17. Minimum of three 10-min sessions on the BAT. ARAT, Upper Extremity Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA-UE). Both the intervention and control groups showed significant improvement on the ARAT from evaluation to discharge (main effect of time: p = .02). There was no statistically significant main effect of group and no significant Time × Group interaction (p = .63). FMA-UE scores also improved significantly in the intervention group from evaluation to discharge (p < .001). FMA-UE scores were not available for the control group. Both the intervention and control groups demonstrated significant improvements in UE function from evaluation to discharge. There were no statistically significant differences between groups, indicating that the BAT results in similar improvements in UE function, as would be expected in traditional occupational therapy. Further research is warranted to examine additional BAT programs, use different outcome measures, and assess participants over a longer time span. Plain-Language Summary: The Bimanual Arm Trainer (BAT) is a novel device that can be used in occupational therapy to improve arm function among stroke patients. There is limited research on BAT's effectiveness in improving arm function among stroke patients. In an acute inpatient rehabilitation setting, we compared outcome scores of patients who received traditional occupational therapy services with those who also used the BAT. Both groups achieved significant improvements in arm function from evaluation to discharge. We found that the addition of the BAT interventions did not significantly affect the outcome measure scores for either group. We conclude that more research is needed to examine additional BAT programs, use different outcome measures, and assess participants over a longer period of time.

Interventions to Improve the Occupational Performance of Youth With Persistent Postconcussion Symptoms: A Systematic Review.

Persistent postconcussion symptoms (PPCS) may negatively affect youth's occupational performance in activities of daily living, education, play and leisure, social participation, and rest and sleep. This review provides occupational therapists with evidence related to interventions for youth with PPCS. Searches were performed in Embase, PubMed, SportDiscus, CINAHL, and Web of Science. Inclusion criteria were as follows: studies published in English from January 1, 2013, to February 7, 2023; youth ages 3 to 18 yr old; PPCS for at least 2 wk after injury; interventions within the scope of occupational therapy; and outcomes related to areas of occupation. All levels of evidence (1-5) were included and graded for quality using the Oxford Centre for Evidence-Based Medicine (2009) levels of evidence. This review followed Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Twenty articles met inclusion criteria (7 randomized controlled trials, 1 nonrandomized controlled group design, 3 single-group designs, 5 case series, and 4 single-subject designs). Interventions reviewed were active rehabilitation, vision-related interventions, psychoeducation, cognitive-behavioral therapy (CBT) techniques, the Cognitive Orientation to daily Occupational Performance (CO-OP), and music therapy. Strong evidence supports CBT, with significant clinical outcomes in sleep and education. Moderate strength of evidence supports psychoeducation and active rehabilitation for improving functional outcomes. More evidence is needed to make clinical recommendations regarding vision-related interventions, the CO-OP, and music therapy. Occupational therapists should consider CBT, psychoeducation, and active rehabilitation to improve occupational performance among youth with PPCS. Plain-Language Summary: Some youth will have persistent symptoms that do not resolve within 2 weeks after a concussion. Because of these persistent symptoms, they may have difficulty completing everyday activities. This review evaluated evidence addressing the ability of youth with persistent postconcussion symptoms (PPCS) to complete everyday activities. The authors found that cognitive-behavioral therapy, psychoeducation (aimed at helping youth understand and cope with their concussion symptoms), and active rehabilitation (aerobic and coordination exercises, such as jumping jacks and ball skills) should be considered when working with youth (ages 3-18 years) with PPCS. Using these interventions in occupational therapy sessions may improve the ability of youth to complete their everyday activities after a concussion.

The potential effect of mobile application-based telerehabilitation on physical activity levels in heart failure patients: insights from the intelliot EU project

Abstract Background Regular physical activity is paramount in heart failure (HF) patients and, due to its well-established benefit in quality of life, functional capacity and prognosis, carries a Class I indication in international guidelines. However, satisfactory compliance rates remain suboptimal, which is largely attributable to unavailability or suboptimal utilization of comprehensive cardiac rehabilitation programs. Digital health application-based telerehabilitation, on the other hand, has emerged as a potentially valuable tools in enhancing risk factor control and lifestyle modification rates in this high-risk patient population. Purpose In this study, we aimed to investigate whether the use of a purpose-designed Internet of Things (IoT)-based e-health system could lead to a clinically relevant increase in physical activity in a cohort of patients with HF across the spectrum of left ventricular ejection fraction (LVEF). Methods Nineteen HF patients were enrolled in the study. Subjects' key clinical characteristics are summarized in Picture 1. All subjects were provided with: a) a set of medical devices with wireless connectivity, b) a state-of-the-art smartwatch and c) a latest-generation smartphone, to which a dedicated patient application was installed. The latter was coupled with a web-based platform designed for physician use, forming the patient-physician interface (PFI). On top of standard-of-care verbal and written exercise recommendations, study physicians also prescribed individualized, guideline-directed exercise regimens for each patient via the PFI, which, in turn, delivered to subjects notifications upon detection of deviations (Picture 2). The first month of participation -during which the smartwatch was used as an activity tracker but exercise notifications had not been activated- served as the baseline period; baseline physical activity level in steps per day was then compared to the respective value measured during each of the 5 following months. Results Mean baseline-to-peak increase in daily step count was calculated at 23.34% (-20.33 - 103.63%). A baseline-to-peak increase in physical activity level of at least 20% was observed in 9/19 patients, with 6 more demonstrating a baseline-to-peak increase in the order of magnitude of 15-19.99%. Only 3 patients failed to achieve any increase in daily step count average. However, after the study month in which the peak physical activity value was observed (typically in the 2nd-4th study month), mean daily step count declined to baseline again in all but 2 patients. Conclusions Despite the study's non-randomized design and small sample size, our results suggest that mobile application-based telerehabilitation constitutes a promising approach in HF patients’ care, as it could aid them achieve a clinically relevant increase in physical activity; this effect, however, can be transient, and this highlights the importance of continued physician oversight.Picture 1: Clinical characteristicsPicture 2: Exercise prescription example

The Effect of a Biofeedback-Based Integrated Intervention for Older Adults with Orthostatic Hypotension: A Secondary Analysis on Psychological Health Outcomes in a Non-Randomized Pilot Trial

Background/Objectives: Aging-related physical changes and dysfunctions in the autonomic nervous system (ANS) often lead to orthostatic hypotension (OH) in older adults. OH negatively impacts both the physical and psychological well-being of those affected. Previous studies have demonstrated that the biofeedback-based integrated program (BBIP), a multicomponent intervention focused on heart rate variability biofeedback, effectively improves OH, as well as symptoms related to ANS function. This substudy aims to examine the effects of the BBIP on psychological health outcomes among community-dwelling older adults with OH. Methods: This study employed a non-randomized controlled trial design with a convenience sampling strategy. A total of 51 older adults with OH were recruited from two senior welfare centers and randomly assigned to either the intervention group (n = 27) or the control group (n = 24). The intervention group participated in a 12-week BBIP, which included weekly biofeedback sessions and group education on lifestyle modification to alleviate OH. Telephone counseling was also provided to promote compliance. Results: The intervention group showed significant improvements in health-related quality of life, depression, anxiety, and fall efficacy after the 12-week BBIP, whereas the control group exhibited no significant changes. There was a significant reduction in the percentage of participants in the intervention group reporting problems in all five dimensions of the EQ-5D (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Conclusions: The BBIP was effective in improving the psychological health outcomes of older adults with OH. Future studies should explore the long-term effects of the BBIP using a larger sample size and a randomized controlled trial design.

Effect of plastic-free diet, education and Bisphenol A exposure feedback on urine BPA in adolescent

Abstract Background BPA is an endocrine disrupting chemical and is mostly taken orally. Adolescence is the critical sensitivity to these chemicals is maximum. This study was conducted to compare the effects of a plastic-free diet program, plastic-free diet education program and BPA exposure feedback on urine BPA levels in adolescents with high use of packaged products. Methods The first phase of the two-phase study is descriptive, the second phase is a single-centre, single-blind, three-arm non-randomized experimental design. The study was conducted at Antalya/Türkiye in the 2022-2023 academic year, and in the first stage, adolescents with high use of plastic packaged products and low attitudes towards healthy nutrition were identified. In the second stage, participants were assigned to the group-1 (n = 36), group-2 (n = 36) and group-3 (n = 36) by simple random sampling method. An eight-week plastic-free diet program was applied to the group 1, plastic-free diet education program and BPA exposure feedback was given to the group-2, and only BPA exposure feedback was given to the group-3. Plastic Packaged Product Usage Survey, Attitude Scale towards Healthy Nutrition, and spot urine samples were used to collect data. Results It was found that 2% of adolescents used low plastic packaging, 34% medium, 57% high, and 7% very high. Pre-posttest urine BPA levels ng/ml (µg/g creatinine) were 1.98 (2.54), 1.43 (1.51) in the intervention1 group, respectively; 1.91 (2.35), 1.43 (1.47) in the intervention2 group; It was found to be 1.97 (2.49) and 1.49 (1.66) in the intervention3 group. The effect sizes of pre-posttest BPA/creatinine values were calculated as 1.38, 1.13 and 1.09 in intervention1-2-3 groups, respectively. Conclusions All three interventions (plastic-free diet program, plastic-free diet education program and BPA exposure feedback) were effective in reducing urinary BPA levels, reducing plastic-packaged product use levels, and increasing attitudes towards healthy eating. Key messages • Since all three interventions are effective in reducing adolescents’ urinary BPA levels, it may be recommended to use the intervention appropriate to the field conditions. • In the post-tests, the use of plastic packaged products by adolescents in all three groups decreased and their attitudes towards healthy nutrition increased.

Dhikr Rateeb Siribee and its Effect in Reducing Anxiety Among the MPTT-I Aceh Congregation Members

The dissemination of information via social media has significantly impacted psychological issues such as stress, fear, and anxiety within society. This is exemplified by the MPTT-I congregation in Aceh, who frequently faces societal rejection regarding their dhikr practices. This study aims to evaluate the effectiveness of dhikr in alleviating anxiety among members of the Indonesian Sufism Study (MPTT-I &amp; Dhikr Rateb Seribe). This study uses a quantitative, quasi-experimental method with a nonrandomized pretest-posttest control group design. The study involved 20 subjects, evenly divided into experimental and control groups. The data collection used the Greenberger and Padesky anxiety scale. The results indicated a significant reduction in anxiety among the MPTT-I congregation following the implementation of the Dhikr. These findings suggest that dhikr is effective in reducing anxiety within the MPTT-I &amp; Dhikr Rateb Seribe community.

Benefit of dual bronchodilator therapy on exacerbations in former and current smokers with chronic obstructive pulmonary disease in real-world clinical practice: a multicenter validation study (TOReTO)

BackgroundDual bronchodilator therapy, consisting of a long-acting beta-agonist (LABA) and a long-acting muscarinic antagonist (LAMA), has proven effective for patients with chronic obstructive pulmonary disease (COPD). However, it remains uncertain whether there are efficacy differences between current and former smokers with COPD. This study aims to explore the effectiveness of LABA/LAMA therapies in both these groups.MethodsThe TOReTO trial assessed lung function, symptoms, health status, the occurrence of exacerbations, clinically significant exacerbations, and the use of LABA/LAMA therapies. These therapies include Tio/Olo, umeclidinium/vilanterol (Umec/Vi), and umeclidinium/vilanterol (Umec/Vi) are used in patients with COPD. The study examined the differences in outcomes between current and former smokers. To balance the baseline characteristics, propensity score matching (PSM) was employed.ResultsData from 967 patients were collected. After PSM, the time to the first acute exacerbation in current smokers was analyzed separately for the three treatment groups and was significantly different between them (p = 0.0457). Among, there are differences in the occurrence of acute exacerbation between treatment and smoking status in Umec/Vi (p = 0.0114). There is no significant difference in the treatment of former smokers among the three different groups of LABA/LAMA fixed-dose combinations (p = 0.3079). COPD-related symptoms remained stable throughout the treatment period. There were no significant differences in symptom scores, including CAT and mMRC, among the three groups at the end of the study.ConclusionsThe three fixed-dose combinations of LABA/LAMA showed no difference in reducing exacerbations in former smokers but did show differences in current smokers. This trend has clinical significance, and future research will be conducted to control influencing variables to validate this point. However, due to the non-randomized study design, these findings should be interpreted with caution.

Potential effect of immediate postpartum use of injectable contraception on lactogenesis

ObjectivesWe evaluated the effect of immediate postpartum use of depot medroxyprogesterone acetate (DMPA) on the timing of lactogenesis stage II (LS-II). Study DesignThe initial design randomly assigned adults who delivered a full-term infant in 2019-2021 to receive within 48 hours of delivery: 1) DMPA, 2) placebo injection, or 3) no injection. Due to low enrollment, we changed in 2021-2023 to a non-randomized design using matching at recruitment for obesity and delivery method and propensity score weighting for analysis. We combined data from both designs to compare immediate postpartum DMPA use (N=55) versus control (placebo or no injection) group (N=95). We defined noninferiority a priori as being met if the upper bound of a two-sided 95% confidence interval (CI) for mean difference in time to LS-II between groups was <6 hours. ResultsThe unweighted mean time to LS-II was 57.8 hours in the DMPA group (SD, 29.4) and 64.1 hours in the control group (SD, 36.1). Using propensity score weighting to make the groups comparable with respect to age, race, delivery method, and previous live births, the mean time to LS-II was 5.5 hours shorter (95% CI, -16.4, 5.5) for women in the DMPA relative to control group. ConclusionsWe found no evidence that DMPA use inhibits the onset of LS-II. Findings support immediate postpartum DMPA initiation among those intending to engage in human milk feeding. ImplicationsA controlled trial (N=150) did not detect any difference in time to lactogenesis stage II (“milk let-down”) between injectable contraception use within the first 48 hours postpartum and those without this exposure.

Effects of Modified Video-Implemented Script Training for Aphasia in the Three Variants of Primary Progressive Aphasia.

Primary progressive aphasia (PPA) is a neurodegenerative disorder characterized by worsening of speech and/or language. Script training intervention promotes automatized speech production via repeated practice of scripted content. This study evaluated the acceptability, feasibility, and effects of a modified version of Video-Implemented Script Training for Aphasia (VISTA) in the three PPA variants and compared outcomes by intervention modality (teletherapy vs. in person). Thirteen bilingual (Spanish-Catalan) participants were included (semantic variant, n = 5; logopenic variant, n = 5; nonfluent/agrammatic variant, n = 3; teletherapy, n = 7). Using a nonrandomized design, intervention was administered in participants' dominant language. Participants were trained on an individualized script twice per week, over 8 weeks. Performance on measures related to script accuracy, content, and subjective ratings of production quality was evaluated at baseline, immediately post, and at 3 and 6 months post-intervention. No significant differences were observed on the basis of intervention modality. Participants demonstrated significant improvements from pre- to post-intervention in script production, synonym production, keywords, and global quality on the trained script. Maintenance was observed when comparing performance at post-intervention relative to 3- and 6-month follow-up for script and synonym production. Significant improvement in production quality of the untrained topic was observed following intervention. Different patterns of benefit were observed by PPA variant. Modified VISTA was acceptable and effective across the three PPA variants, as evidenced by improvements on a broader array of outcome measures than those previously reported. Findings also provide further support for provision for teletherapy in individuals with PPA. https://doi.org/10.23641/asha.26999326.

Yoga Intervention and Inflammatory Homoeostasis in Breast Cancer Patients

Objectives: Yoga, renowned for its ability to maintain physical, mental and spiritual well-being, has recently gained prominence as a supportive therapy during conventional breast cancer (BC) treatment. This paradigm shift reflects a growing trend of people embracing yoga to enhance their overall health and aid in managing BC. The objective of this study was to determine the yoga intervention and inflammatory homoeostasis in newly diagnosed BC patients. Materials and Method: This study recruited 44 newly diagnosed BC patients at stages II, III and IV (without distant metastasis or other inflammatory diseases), all admitted for neoadjuvant chemotherapy followed by surgery. A prospective non-randomised control design was employed. Baseline assessments were conducted before the first chemotherapy cycle, with follow-ups before the 2nd and 3rd chemotherapy cycles, before surgery, and 2 months post-surgery. The outcome was compared with the control group. Results: The study showed significant within-subject effects in the yoga intervention group on serum tumour necrosis factor-alpha, interleukin (IL)-1-beta and IL-6 levels, while no significant changes were observed in the control group. Although between groups did not show statistically significant, the mean values indicated a consistent downregulation of proinflammatory markers over time in the yoga group. Conclusion: Incorporating yoga as a complementary therapy alongside conventional BC treatment significantly improved the health outcomes of BC patients by modulating proinflammatory markers.

Effects of cognitive training and group psychotherapy on cognitive performance of post COVID-19 patients: an exploratory and non-randomized clinical trial.

Cognitive complaints are common signs of the Post COVID-19 (PC) condition, but the extent and type of cognitive impairment may be heterogeneous. Little is known about neuropsychological treatment options. Preliminary evidence suggests cognitive symptoms may improve with cognitive training and naturally over time. In this clinical trial, we examined whether participation in a weekly group consisting of cognitive training and group psychotherapy is feasible and would exert beneficial effects on cognitive performance in PC and whether improvements were associated with intervention group participation or represented a temporal improvement effect during syndrome progression. 15 PC patients underwent an 8-week intervention. Cognitive performance was assessed before and after each intervention group participation. A control group of 15 PC patients with subjective neurocognitive or psychiatric complaints underwent two cognitive assessments with comparable time intervals without group participation. To attribute changes to the intervention group participation, interaction effects of group participation and time were checked for significance. This is an exploratory, non-randomized, non-blinded controlled clinical trial. Within the intervention group, significant improvements were found for most cognitive measures. However, significant time x group interactions were only detected in some dimensions of verbal memory and visuo-spatial construction skills. Significant time effects were observed for attention, concentration, memory, executive functions, and processing speed. The intervention setting was feasible and rated as helpful and relevant by the patients. Our results suggest that cognitive symptoms of PC patients may improve over time. Patients affected by both neurocognitive impairments and mental disorders benefit from group psychotherapy and neurocognitive training. The present study provides evidence for a better understanding of the dynamic symptomatology of PC and might help to develop further studies addressing possible therapy designs. The main limitations of this exploratory feasibility trial are the small sample size as well as the non-randomized design due to the clinical setting.

The efficacy of an intracoronary cocktail administration in preventing no-reflow during excimer laser coronary angioplasty in patients with in-stent restenosis: A pilot study. (ELCA- cocktail study)

BackgroundThe no-reflow phenomenon is a significant complication during excimer laser coronary angioplasty (ELCA) procedures, which can lead to adverse outcomes. This study explores the efficacy of intracoronary administration of a cocktail solution comprising nitroglycerin, heparin, and verapamil on preventing no-reflow during ELCA in patients with in-stent restenosis (ISR). MethodsThis study included patients undergoing ELCA with contrast infusion for ISR. Based on whether receiving the intracoronary cocktail solution during ELCA, participants were divided into two groups: the cocktail (+) group and the cocktail (−) group. The primary endpoint was the incidence of no-reflow, which was defined as the cessation of blood flow into the distal coronary artery in the absence of a clear angiographic explanation for impairment of flow. ResultsA total of 54 lesions in 51 patients were included. The mean age of the study population was 61.8 ± 9.7 years, with 84.3 % male. Baseline clinical characteristics were well-balanced. The incidence of no-reflow was significantly lower in the cocktail (+) group compared to the cocktail (−) group (0 % vs. 17.9 %, P = 0.024). No cases of hypotension, major bleeding or coronary perforation in either group. Major adverse cardiac events (MACE) within 6-month were no significant difference between the groups (4.0 % vs. 3.8 %, P = 0.977). ConclusionsThe pilot study suggests that intracoronary administration of a cocktail comprising heparin, nitroglycerin, and verapamil may reduce the incidence of no-reflow during ELCA in patients with ISR. However, given the limited sample size and the non-randomized design, these findings should be considered hypothesis-generating. Future validation needs to be confirmed through multicenter studies with larger sample sizes.

Hysterectomy versus Uterine Preservation for Pelvic organ prolapse Surgery (HUPPS): A prospective cohort study

One in five females will have surgery to treat pelvic organ prolapse in their lifetime. Uterine-preserving surgery involving suspension of the uterus is an increasingly popular alternative to the traditional use of hysterectomy with vaginal vault suspension to treat pelvic organ prolapse; however, comparative evidence with native tissue repairs remains limited in scope and quality. To compare 1-year outcomes between hysterectomy-based and uterine-preserving native tissue prolapse surgeries performed through minimally invasive approaches. We used a non-randomized design with patients self-selecting their surgical group to integrate a pragmatic, patient-centred, and autonomy-focused approach. Participants chose between uterine-preserving surgery or hysterectomy-based surgery, guided by neutral, evidence-based discussions and individualized decision-making, with support from fellowship-trained urogynecologists. Inverse probability of treatment weighting based on high-dimensional propensity scores was used to balance baseline differences across surgical groups in an effort to resemble a randomized clinical trial. A prospective cohort study of 321 participants with stage ≥2 prolapse involving the uterus who desired surgical treatment were recruited between 2020 and 2022 and followed to 1 year (retention >90%). Patients chose to receive uterine-preserving POP surgery through hysteropexy (n=151) or hysterectomy with vaginal vault suspension (n=170; reference group), with repair of anterior and/or posterior prolapse if indicated. The primary outcome was anatomic prolapse recurrence within one year, defined as apical descent ≥50% of the total vaginal length. Secondary outcomes were peri-operative, functional, clinical, and healthcare outcomes measured at 6 weeks and 1 year. Inverse probability of treatment weighted linear regression and modified Poisson regression were used to estimate adjusted mean differences (aMD) and relative risks (aRR), respectively. Apical anatomic recurrence rates at 1 year were 17.2% following hysterectomy and 7.5% following uterine-preservation, resulting in an adjusted relative risk of 0.35 (95% CI 0.15, 0.83). Uterine-preserving surgery was associated with shorter length of surgery (aMD -0.68 hours [-0.80, -0.55]) and hospitalization (aMD -4.34 hours [-7.91, -0.77]), less use of any opioids within 24 hours (aRR 0.79 [0.65, 0.97]), and fewer procedural complications (aRR 0.19 [0.04, 0.83]) than hysterectomy. Up to 1 year, uterine-preserving surgery was associated with lower risk of composite recurrence (stage ≥2 prolapse in any compartment or retreatment; aRR 0.47 [0.32, 0.69]) than hysterectomy, driven by anatomic outcomes. There were no clinically meaningful differences in functional or healthcare outcomes between surgical groups. This study adds real-world evidence to the growing body of research supportive of uterine-preserving surgery as a safe, efficient, and effective alternative to hysterectomy during native tissue prolapse repair. Given mounting evidence on safety, efficiency, and effectiveness of uterine-preserving surgery and its alignment with the preferences of approximately half of patients to keep their uterus, the standard of care should include routine offering and patient choice between uterine-preserving and hysterectomy-based surgery for pelvic organ prolapse.

Assessing the Impact of the Way of Saint James on Psychological Distress and Subjective Well-being: The Ultreya Study

This study aimed to examine the impact of a pilgrimage on the Way of St. James on psychological distress and subjective well-being, and to compare these outcomes with a control group on non-pilgrimage vacations. Additionally, the study explored psychological process variables that may mediate the pilgrimage's beneficial effects. A nonrandomized pretest-posttest design was used, involving 444 pilgrims and 124 controls. Participants completed baseline and post-experience self-reported measures of psychological distress, subjective well-being, and psychological processes (i.e., mindfulness, nonattachment, engaged living). A 3-month follow-up was conducted only in the pilgrim group. Mediation analyses examined psychological processes as potential mediators of pre-post change in the pilgrim group (vs. control). Within-group analyses revealed that the pilgrim group experienced improvements in psychological distress, subjective well-being, and psychological processes immediately post-experience, with most measures sustaining improvement at the 3-month follow-up. Compared to the control group, pilgrims showed significantly greater increases in positive affect, life satisfaction, and valued living, alongside greater reductions in anxiety, depression, and perceived stress. Valued living partially mediated the relationship between pilgrimage and positive affect, and fully mediated the effects on perceived stress, negative affect, life satisfaction, and subjective happiness. Pilgrimage on the Way of St. James effectively reduced psychological distress and enhanced subjective well-being, with greater benefits observed compared to a non-pilgrimage vacation control group. Consistent with the concept of pilgrimage as a transformative experience, significant improvements in valued living were noted, which mediated some of the positive outcomes post-pilgrimage. The Way of St. James may serve as a valuable complementary approach for alleviating distress and promoting well-being. Further studies exploring the effects of this pilgrimage on specific populations and using more robust study designs are warranted.Trial Registration ClinicalTrials.gov Identifier NCT04141813.

Enhancing Students' Conceptual Understanding of Newton Law with Conceptual Problem Solving Learning: An Experimental Study

This study aims to examine the effectiveness of Conceptual Problem Solving-based learning in improving student conceptual understanding of Newtonian mechanics. The quasi-experimental method with a nonrandomized control group pretest-posttest design was used to compare students conceptual in the experimental and control class. The subjects in this study were 69 first-year students of the Physics Education study program at one of the state universities in Yogyakarta. Force Concept inventories are used to assess students conceptual understanding of Newtonian mechanics. The findings revealed that there was significant difference in the increase in students conceptual understanding between the experimental and control groups. The increase in conceptual mismatch in experimental class students using CPS learning was higher (N-gain = 0.33) compared to control class students using direct instruction learning (N-gain = 0.11), although both groups experienced an increase. This study provides a real picture that the CPS technique can be used as a more successful strategy to improve the quality of physics learning, especially in improving knowledge of basic topics that are often difficult for students to understand, one of which is Newton's Law.

Providing access to cognitive-behavioral therapy for insomnia in cancer care: Preliminary results of an implementation study.

61 Background: Between 30 to 60% of cancer patients display insomnia symptoms. While cognitive-behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment for cancer-related insomnia, it remains underutilized due to its limited accessibility. To date, we are unaware of any study that has investigated the implementation of CBT-I in routine clinical care. Our prior work showed that a stepped care approach, combining a web-based CBT-I and 1-3 booster therapy sessions, was not significantly inferior in producing sleep improvements than a standard 6-session CBT-I. The main goals of the IMPACT (Insomnia in Patients with Cancer – Personalized Treatment) program are to assess the feasibility and efficacy of implementing this stepped care CBT-I in four cancer centers in Quebec City, Canada. Methods: The ongoing study uses a stepped wedge cluster non-randomized design implementing the stepped care CBT-I at various time intervals across cancer centers. All first-line cancer providers (e.g., nurses, oncologists, radio-oncology technologists, pharmacists) are met every 3-4 months to present/remind them of the rationale of the project and procedures to refer patients to the IMPACT program. Patients having a score ≥ 4 on the sleep item of the Edmonton System Assessment System-Revised (ESAS-R-sleep) receive a leaflet explaining the stepped care CBT-I and how to access the web-based program (first step). Patients with residual insomnia symptoms after completing this first step are offered 1-3 booster sessions with a clinical psychologist (second step). Uptake and retention rates are the main variables. Results: Across cancer centers, 11.9%-50.8% of patients having a score ≥ 4 on the ESAS-R-sleep item were referred to the IMPACT program. The most common reasons for not referring were: 1) the presence of comorbid anxiety or depression symptoms (they were referred instead to the psychosocial oncology team) and; 2) patients declining help. Registration rates were greater when a brief follow-up phone call was conducted to explain the IMPACT program in more detail (vs. giving only the leaflet). Across cancer centers, 10%-54.9% of referred patients registered with the web-based CBT-I, 83.3%-90% of them initiated it and 26%-42.3% completed it. The most common reasons for not completing the web-based CBT-I were: 1) sleep difficulties improved or remitted (36.2%); and 2) the program did not meet patients’ needs (23.4%). Among completers, 29%-56% had residual insomnia and were offered booster sessions. On average, sleep diary data collected during treatment (N=83) indicated a reduction of sleep-onset latency of 20 min and of wake after sleep onset of 45 min. Sleep efficiency increased from 70 to 85%. Conclusions: Although uptake and retention rates could be improved, these preliminary data suggest that stepped care CBT-I can be implemented in routine cancer care and is effective. Clinical trial information: NCT04817163 .

The Influence of the Project-Based Learning (PjBL) Model on Student's Science Process Skills and Critical Thinking

Applying the project-based learning model in learning can train and develop scientific attitudes and problem-solving skills so that students can increase creativity, innovation, and critical perspectives. This research aims to determine the effect of the project-based learning model on student's science process skills and critical thinking. The research subjects of class X Phase E. This research was quantitative research with a quasi-experimental research design with a non-randomized control-group pretest-posttest design. The instruments used are essay questions on science process skills and critical thinking. The test results were analyzed using Quade's rank analysis of covariance statistical test and the One Way Ancova test. The research results show that the average pretest-posttest score of experimental class students taught using the project-based learning model is higher than that of control class students taught using the problem-based learning (PBL) model. Hypothesis testing using Quade's rank analysis of Covariance and One Way Ancova tets informs that the use of the project-based (PjBL) model affects student's science process skills and critical thinking.

The Effect of Educational Games on Fine Motor Ability For Children Aged 4-5 Years in Kindergarten

Objective: This study aims to know the influence of educational games on the abilities of children 4–5 years old in the garden.​​ Method: Design used in study This is a nonrandomized pretest-posttest control design where two groups are group experiments and group control with a quantitative approach. These research subjects are Child Group A at Al Falah Assalam Kindergarten, which has as many as 26 students as class experiments, and Children Group A at Kindergarten Al Falah Darussalam, which has as many as 26 students as class control. Deep data analysis techniques use non-parametric statistics, such as the Mann-Whitney Test. Results: This research showed that educational games have influenced young children aged 4-5 years. This is known from the results of the posttest carried out in the control class, where the increase was not significant, like the results of the posttest carried out in the experimental class, which previously carried out treatment activities. Novelty: The novelty of this research is using educational games to play in real life so that young children can touch and feel. This educational game can be used to introduce not only letters but also numbers, shapes, and colors.

The relationship between workplace bullying and family functioning: A systematic review.

While the occupational and health-related consequences of workplace bullying have received extensive research attention, the effects of workplace bullying on the family domain have been largely ignored. Based on the PRISMA framework, the Scopus, Web of Science, PsycINFO, and PubMed databases were searched up to May 12, 2024, for articles on associations between workplace bullying and family functioning. A total of 1347 articles were identified, of which 37 were found after review to meet the criteria for inclusion. All the included studies found a direct or indirect association between workplace bullying and family functioning. Most studies are grounded in the conservation of resources (COR) theory, spillover theory, crossover theory, and work-family interface model. Negative affect (emotions), work-family conflict (WFC), and burnout were considered essential mechanisms explaining the links between workplace bullying and family functioning, with personal resources (demands) as the main moderators. Most studies focus on the one-way impact of workplace bullying on family functioning, mainly using cross-sectional, non-randomized self-report designs. Future research will benefit from using a longitudinal design, continued characterization of the workplace bullying-family functioning relationship, including its nature, direction, processes, and boundary conditions in various industrial and cultural contexts, together with the use of models for the integration of research findings.

Engaging healthcare teams to increase access to medications for opioid use disorder.

To assess the effectiveness of evidence-based quality improvement (EBQI) as an implementation strategy to expand the use of medications for opioid use disorder (MOUD) within nonspecialty settings. We studied eight facilities in one Veteran Health Administration (VHA) region from October 2015 to September 2022 using administrative data. Initially a pilot, we sequentially engaged seven of eight facilities from April 2018 to September 2022 using EBQI, consisting of multilevel stakeholder engagement, technical support, practice facilitation, and data feedback. We established facility-level interdisciplinary quality improvement (QI) teams and a regional-level cross-facility collaborative. We used a nonrandomized stepped wedge design with repeated cross sections to accommodate the phased implementation. Using aggregate facility-level data from October 2015 to September 2022, we analyzed changes in patients receiving MOUD using hierarchical multiple logistic regression. Eligible patients had an opioid use disorder (OUD) diagnosis from an outpatient or inpatient visit in the previous year. Receiving MOUD was defined as having been prescribed an opioid agonist or antagonist treatment or a visit to an opioid substitution clinic. The probability of patients with OUD receiving MOUD improved significantly over time for all eight facilities (average marginal effect [AME]: 0.0057, 95% CI: 0.0044, 0.0070) due to ongoing VHA initiatives, with the probability of receiving MOUD increasing by 0.577 percentage points, on average, each quarter, totaling 16 percentage points during the evaluation period. The seven facilities engaging in EBQI experienced, on average, an additional 5.25 percentage point increase in the probability of receiving MOUD (AME: 0.0525, 95%CI: 0.0280, 0.0769). EBQI duration was not associated with changes. EBQI was effective for expanding access to MOUD in nonspecialty settings, resulting in increases in patients receiving MOUD exceeding those associated with temporal trends. Additional research is needed due to recent MOUD expansion legislation.