Pilot Study Research Articles

A Non-Randomized Pilot Trial of Brain-WISE: A Group-Based Program for Brain Health and Dementia Risk Reduction in Community Settings.

BackgroundAddressing modifiable risk factors can potentially prevent 45% of cases of dementia. Here, we present the development of Brain-WISE, a low-intensity, group-based intervention to improve brain health in community settings. We conducted preliminary testing to refine intervention materials and procedures, assess acceptability and adherence, and evaluate preliminary effects.Methods143 community-dwelling adults aged 56-93 completed the non-randomized pilot trial. The 6-session intervention included psychoeducation, discussion/activities, and health screenings. Adherence was measured by attendance and acceptability was measured with questionnaires. Brain health knowledge and motivation to improve brain health were assessed before and after the program.ResultsAcross 6 cohorts, attendance was 80% - 97% and 96% of participants agreed that the program was worthwhile. Knowledge (d = 0.83, P < .001) and motivation (d = 0.43, P < .001) increased significantly.ConclusionsThe Brain-WISE program displayed good adherence and acceptability and evidence of an effect on knowledge and motivation. Further testing is warranted.

A randomized pilot and feasibility trial of live and recorded music interventions for management of delirium symptoms in acute geriatric patients

BackgroundDelirium is an acute shift in attention and arousal, usually triggered by acute illness or surgery in older dementia patients. Prognosis is poor, and pharmacological options are limited; non-pharmacological interventions and music show promise.MethodsThis randomised pilot and feasibility trial tested feasibility, acceptability, fidelity, and safety of music interventions (MIs) for delirium patients and assessed preliminary effectiveness and suitability of the selected effect outcomes. Participants from an acute geriatric ward were randomised to Preferred Recorded Music (PRM) and Preferred Live Music (PLM), delivered for 30 min over three consecutive days. Feasibility outcomes included recruitment rate, retention, adherence, deviations, and treatment fidelity. Clinical outcomes were trajectory of delirium symptoms (arousal, attention, cognition), delirium duration, hospital stay length, and medication intake. Post-intervention and between groups changes in delirium symptoms were compared using mixed linear regression models for the repeated measurements. Mann-Whitney test and Fishers exact test were used for length of stay and medication use, respectively.Results26 participants (PLM = 14; PRM = 12), median age 87, most with hypoactive delirium were recruited at a rate of three participants per month. Retention rates for PLM and PRM were 64% and 33% respectively and adherence to PLM and PRM intervention protocols were 83% and 58%, respectively. Total adherence to the assessment protocols was 44%. PLM was delivered as intended, (treatment fidelity 93%), and PRM did not satisfy treatment fidelity (83%). All delirium symptoms except arousal improved on day 3 compared to baseline, with statistically significant improvement in attention. No conclusive pre-post or between-group differences were detected for any outcomes; confidence intervals were wide.ConclusionsFeasibility of recruitment, interventions and assessments was indicated, and greater acceptability, safety and fidelity of the PLM intervention compared with the PRM. Adoption of external assessors is warranted in future trials, to mitigate slow recruitment and low adherence. Wide confidence intervals for most measures and comparisons indicate that the possible effect of the MIs on delirium cannot be excluded. The trial was registered at Clinical Trials, ID: NCT05398211, on 31/05/2022.

Effect of BCG vaccination on immune-regulatory markers and glycemic control in children with new-onset type 1 diabetes mellitus (T1DM): A randomised double-blinded placebo-controlled pilot trial

Effect of BCG vaccination on immune-regulatory markers and glycemic control in children with new-onset type 1 diabetes mellitus (T1DM): A randomised double-blinded placebo-controlled pilot trial

Inconsistency between abstract and main text reporting is common in pilot randomized controlled trials of surgical interventions: A methodological survey.

Inconsistency between abstract and main text reporting is common in pilot randomized controlled trials of surgical interventions: A methodological survey.

Exploring 24-Hour Movement Behaviors in Early Years: Findings From the SUNRISE Pilot Study in Tunisia.

The International Study of Movement Behaviors in the Early Years(SUNRISE) was conducted in Tunisia to assess the proportion of preschoolers who met the World Health Organization guidelines for physical activity, sedentary behavior, and sleep. The study also evaluated the feasibility of the methods for the SUNRISE study. Five kindergartens were recruited from urban and rural areas in Tunisia. Physical activity and sleep duration were assessed using a waist-worn ActiGraph. Screen time and sleep quality were assessed via an interview-administered parent questionnaire. The NIH Toolbox was used. A total of 112 preschoolers were assessed (50 boys, age = 4.1 [0.58]). Only 18% of children met all recommendations of the World Health Organization guidelines, while 53% met the sedentary screen time (in minutes per day), and 41% met physical activity recommendation (in minutes per day). Eighty-one percent of children met the sleep duration recommendation (in minutes per day). There was good compliance with the ActiGraph protocol. This pilot study provided important insights into the feasibility of the study and the movement behaviors of Tunisian preschool children. The results suggest there is a need to promote healthy levels of physical activity and sedentary screen time in children, which should be a priority in public health initiatives, including preschool curricula, in Tunisia.

Effectiveness and feasibility of family and peer challenge intervention with wearable technology on physical activity among middle schoolers in Utah: A pilot trial

Effectiveness and feasibility of family and peer challenge intervention with wearable technology on physical activity among middle schoolers in Utah: A pilot trial

Exploring the mechanisms of action of probiotics in depression: Results from a randomized controlled pilot trial.

Exploring the mechanisms of action of probiotics in depression: Results from a randomized controlled pilot trial.

Robotic beds for the treatment of positional obstructive sleep apnea - A randomized cross-over pilot trial.

Interventions leading to avoidance of supine position and thus reducing the likelihood of upper airway collapse during sleep are a treatment approach for positional obstructive sleep apnea (POSA). The aim of this randomized cross-over trial was to assess the effect of two actuated beds (trunk-elevation and sideward-tilting) on OSA severity and sleep fragmentation in POSA. After baseline polysomnography, adult patients with POSA were randomly assigned to two nights of intervention in the intelligent sleep apnea bed ISABel1 and ISABel2. In the case of obstructive apnea or hypopnea, ISABel1 elevated the upper body by 50° and ISABel2 induced a unilateral bed tilt of 40°, with both interventions lasting 10min. Sustained trunk elevations without sliding down (ISABel1) and position change from supine to non-supine (ISABel2) were defined as successful interventions. Six adult men (57±11 years, BMI 28±4kg/m2, AHI 39±15/h) with POSA were included. Neither trunk elevation (ISABel1) nor side tilt (ISABel2) - approximately 10 interventions per night - significantly reduced apnea-hypopnea index (AHI), whereas trunk elevation showed a tendency to reduce supine AHI. Actuated beds had no effect on sleep efficiency and arousals. Only 13% of side tilts in ISABel2 resulted in a successful shift to a non-supine position. The time to the next respiratory event after bed movement was longer in the trunk elevating bed than in the side-tilting bed. Trunk elevating beds decrease supine AHI and both side-tilting and trunk elevating beds increase the time to the next obstructive apnea or hypopnea.

The safety and feasibility of transcranial direct current stimulation and exercise therapy for the treatment of cervicogenic headaches: A randomized pilot trial.

Our primary objective was to evaluate the safety and feasibility of transcranial direct current stimulation combined with exercise therapy for the treatment of cervicogenic headache. Our exploratory objectives compared symptoms of headache, mood, pain, and quality of life between active and sham transcranial direct stimulation combined with exercise therapy. Cervicogenic headache arises from injury to the cervical spine or degenerative diseases impacting cervical spine structure resulting in pain, reduced quality of life, and impaired function. Current standard-of-care treatments such as radiofrequency ablation, pharmacotherapy, manual therapy, and exercise therapy lack efficacy for some patients. Transcranial direct current stimulation is a neuromodulation technique that has shown promise in treating chronic pain conditions by positively altering neuronal activity but has not been evaluated as treatment for cervicogenic headache. This double-blind, sham-controlled, randomized, feasibility trial recruited 32 participants between the ages of 18 and 65 years that met the International Classification of Headache Disorders third edition criteria for cervicogenic headache. Participants were randomized to receive either active or sham transcranial direct current stimulation both combined with daily exercise therapy over 6 weeks. Transcranial direct current stimulation was applied over the primary motor cortex ipsilateral to worse pain for 20 min at 2 mA with a 30 s ramp up/down period. Recruitment, retention, and adherence were evaluated for feasibility. Safety was assessed through serious and minor adverse events and an adverse effect questionnaire. Clinical outcome measures assessed headache, pain, quality of life, and mood symptoms at pre-treatment, post-treatment, and 6- and 12-weeks post-treatment. A total of 97 participants were contacted to participate with 32 recruited, 16 randomized into each group, and 14 completing the treatment protocol in both groups. Within each group 12 (active) and nine (sham) completed treatment within the proposed 6 weeks (three sessions per week), others received 18 sessions but took longer. Exercise therapy was completed on an average of 87% of days for both groups. Transcranial direct current stimulation was safe, with no serious adverse events and one minor adverse event in the active group. Itching was a more common post-intervention complaint in the active group (64% active vs. 43% sham). Exploratory analysis revealed significant group × time interactions for average headache pain from pre- to post-treatment (β = -1.012, 95% confidence interval [CI] -1.751 to -0.273; p = 0.008), 6-weeks (β = -1.370, 95% CI -2.109 to -0.631; p < 0.001), and 12-weeks (β = -1.842, 95% CI -2.600 to -1.085; p < 0.001) post-treatment, and for neck pain from pre- to post-treatment (β = -1.184, 95% CI -2.076 to -0.292; p = 0.010) and 12-weeks (β = -1.029, 95% CI -1.944 to -0.114; p = 0.028) post-treatment favoring active vs. sham. There were no significant group × time interactions for quality of life or mood. The combination of transcranial direct stimulation and exercise therapy is safe and feasible for treating cervicogenic headache. While some promise has been shown for reducing headache and neck pain, larger scale trials with adequate power are needed to confirm these findings.

Transcranial Direct Current Stimulation (tDCS) in the Treatment of Youth Depression: Integrating Literature Review Insights in a Pilot Clinical Trial

Background: Youth (ages 16–25) is a key window for mental health interventions, as depression rates significantly increase during this developmental stage. However, transcranial direct current stimulation (tDCS) application in youth depression remains underexplored. To reduce the uncertainty of a future trial, we conducted a review and a pilot randomised controlled trial (RCT) of tDCS for youth depression. Methods: Following the PRISMA guidelines, the first part of this study was a review across databases including PubMed, MEDLINE, PsychInfo, CINAHL, Open Access Theses and Dissertations (OATD), WanFang Data, Chinese Medical Journal, and clinical trial registries up to 20 November 2024, on tDCS treatment for youth depression. The second part of this study was a double-blind pilot RCT assessing feasibility, by comparing active tDCS (five daily 30 min 2 mA anodal tDCS applications over the left dorsolateral–pre-frontal-cortex (DLPFC) with sham tDCS. Feasibility outcomes included recruitment, data collection, attendance, retention and randomisation. Outcomes also included depression severity using the Hamilton Depression Rating Scale (HDRS), safety, tolerability, acceptability, and adequacy of blinding. Mann–Whitney U tests were used for between-group comparison. Results: Fourteen eligible studies were identified, with a pooled HDRS reduction of −9.6 (95% CI: −11.2 to −8.1, p &lt; 0.001), though high risks of bias indicated a research gap. Using parameters derived from the review, we conducted a pilot RCT in which 20 youths were screened and 8 were randomised (aged 16–24; 3 females, 5 males). All randomised participants completed their assigned sessions without dropout or protocol discontinuations. Blinding was adequate, and participants’ willingness to engage improved over time. Both groups showed reductions in HDRS, with a greater mean reduction in the active group (−4.75 ± 2.96) compared to the sham group (−3.75 ± 3.78). No serious adverse events occurred, with only mild headaches and tingling reported. The tolerability profile was comparable. However, the decentralised administration of sessions may have introduced inconsistent tDCS applications. Conclusions: This review highlights a lack of RCTs on tDCS for youth depression. Our pilot trial demonstrates the feasibility of a sham-controlled design in youth depression, justifying larger-scale trials to evaluate the efficacy of tDCS in this population.

A randomised pilot trial for bedtime procrastination: Examining the efficacy and feasibility of the Reducing Evening Screen Time online intervention (REST-O).

A randomised pilot trial for bedtime procrastination: Examining the efficacy and feasibility of the Reducing Evening Screen Time online intervention (REST-O).

Impact of sterile Aedes aegypti males releases on vector dynamics: insights from Malaysian field trials

BackgroundThe Sterile insect technique (SIT) has been successfully used in agricultural pest control, leading to interest in its application for public health, particularly in controlling Aedes mosquitoes in the USA, Italy, Cuba, and Greece. Malaysia has conducted a small-scale SIT pilot trial since 2019 for dengue control. This study evaluates mosquito populations in treated and untreated sites through three objectives: (1) comparing mean larvae per trap (MLT) and dengue cases for Ae. aegypti and Aedes albopictus; (2) estimating survival rates and wild populations using mark-release-recapture (MRR); and (3) analysing spatial distribution in treated and untreated sites.MethodsAe. aegypti males, irradiated at 55 Gray, were released in three locations: Pangsapuri Kota Laksamana (KT), Malacca (19 months), Pangsapuri Taman Tasik Utama (TTU), Malacca (8 months), and the Customs, Immigration, and Quarantine Complex (CIQ), Johor (7 months). Statistical analyses assessed SIT effectiveness, including T-tests for larval density and ovitrap indices, Mulla’s formula and relative variance (RV) for population reduction, and the Lincoln Index for estimating wild male populations and probability of daily survival.ResultsWeekly releases of sterile Ae. aegypti males at doses of 1278–7942 males/ha achieved a sterile-to-wild male ratio of 5.85 and a mean daily survival rate of 0.61, leading to significant reductions in larval densities: 76.25% in Kota Laksamana (KT), 96.74% in Taman Tasik Utama (TTU), and 89.00% in CIQ Gelang Patah, thereby supporting dengue control efforts. In KT, the MLT was initially low but increased, although with suppression < 90%, there was a reduce of dengue cases throughout the release period. The MRR’s mean survival rate (± standard deviation) in KT was 0.61 (± 0.08). The spatial clustering of Ae. aegypti was observed in central blocks during the high MLT period. However, larval densities rebounded after releases ceased. Spatial clustering revealed no initial clustering, though clustering patterns emerged over time in KT.ConclusionsSIT effectively suppressed Ae. aegypti populations and supported dengue control. Optimizing sterile-to-wild male ratios, spatial distribution, and monitoring strategies is essential for sustainable vector control. These findings provide insights for scaling up SIT field trials, with future efforts focusing on refining release and monitoring strategies to enhance SIT as an effective dengue control tool.Trial registration NMRR-17–2652-39,099 “Field evaluation of Sterile Insect for Aedes aegypti Suppression.”

Empowerment among treatment-engaged individuals living with schizophrenia in Tanzania

PurposeAs low-resource settings move to address the treatment and social service gap for people living with schizophrenia (PLWS), person-centered and recovery-oriented interventions should monitor impacts on empowerment. This study explores empowerment and associated factors among PLWS in Tanzania.MethodsThis study uses endline data from the Culturally Adapted Family Psychoeducation for Adults with Psychotic Disorders in Tanzania (KUPAA) pilot trial. Participants included 66 dyads of PLWS and caregivers recruited from two tertiary-level hospitals. The main outcome variable of interest was empowerment (Rogers 28-item Empowerment Scale), and the main exposure variable was Participation in Society (Domain 6 of the WHO Disability Assessment Schedule, WHODAS 2.0). Key psychosocial correlates of interest included hopefulness, general self-efficacy, internalized stigma, and family functioning. Bivariate and multivariable analyses were used to explore variable relationships.ResultsThere were 21 women and 40 men with a mean age of 32 years. Bivariate analyses revealed greater participation in society (p < 0.0003) was correlated with greater empowerment, higher hopefulness (p < 0.0001) and higher self-efficacy (p < 0.0001). Lower empowerment was correlated with higher self-stigma (p < 0.0001) and worse family functioning (p < .001). Multivariable models indicated more participation in society was associated with higher empowerment, but when hope, self-efficacy, internalized stigma, and/or family functioning were added to the models, those factors were more strongly correlated with empowerment than participation in society.ConclusionEmpowerment is increasingly being recognized as an important outcome of psychosocial interventions. Understanding empowerment and its possible effects on recovery-centered outcomes is important when thinking of future interventions for PLWS in low-resource settings. Future recovery-oriented interventions and research should both consider including empowerment measurement among PLWS and incorporate their lived experiences in psychosocial treatment programming.

Therapeutic Efficacy of an Isotonic Saline Solution Enriched with Mullein, Thyme, and Long-Chain Polyphosphates in Pediatric Acute Rhinitis: A Randomized Controlled Trial

Background and aim. Acute rhinitis (AR) is a common condition in children, primarily of viral origin, causing nasal congestion, rhinorrhea, and discomfort, with a significant impact on quality of life and economic burden. Current treatments are limited to symptomatic relief, with nasal irrigation being the primary non-pharmacological intervention. This study aimed at evaluating the efficacy and safety of Elysium Naso-gola—an isotonic saline solution enriched with mullein (Verbascum thapsus), thyme (Thymus vulgaris), propolis, and long-chain polyphosphates—in reducing symptom severity and duration in pediatric AR. Methods. A randomized, double-blind, placebo-controlled pilot trial was conducted on 60 children (aged 4–14 years) with AR. Participants were randomized into two groups: the active group received Elysium Naso-gola, while the placebo group received a sterile isotonic saline solution, both administered as nasal sprays four times daily for seven days. Symptom severity was assessed at baseline (T0), day 5 (T1), and day 10 (T2) using the I-NOSE questionnaire and Visual Analog Scale (VAS). The primary outcome was symptom reduction at T1, while secondary outcomes included nasal obstruction improvement and complete symptom resolution at T2. Results. At baseline, both groups exhibited comparable symptoms severity. At T1, the active group showed a significant reduction in I-NOSE scores compared to placebo group (p &lt; 0.05), with a marked decrease in nasal obstruction severity. VAS scores also indicated a greater improvement in nasal breathing in the active group. At T2, complete symptom resolution was achieved in 60% of patients treated with Elysium Naso-gola, compared to only 5.3% in the placebo group (p &lt; 0.01). No adverse events were reported, and treatment adherence was high in both groups. Conclusions. The findings suggest that Elysium Naso-gola is a safe and effective non-pharmacological treatment for pediatric AR, providing faster symptom relief and higher resolution rates. Larger multicenter trials are warranted to confirm these preliminary results and further explore its role in pediatric respiratory care.

Recovery of Non-Ferrous (Cu & Ni) and Precious (Au) Metals from Waste Random Access Memory (RAM)

ABSTRACT Random access memory (RAM) of printed circuit boards (PCBs) is an integral component of most electronic devices. It is one of the vital electronic component that poses significant environmental challenges when discarded but economically significant as it contains non-ferrous and precious metals. The objective of the present work proposes a promising hydrometallurgical process flow sheet to recover copper (Cu), nickel (Ni) and gold (Au) metals from RAM PCBs using mechanical pre-treatment with selective leaching followed by solvent extraction and adsorption techniques. Leaching parameters were optimized for maximum dissolution and extraction of base metals. More than 99% leaching of Cu and Ni were achieved selectively using 1 M H₂SO₄ and 10% HNO₃ leaving Au in residue. Leaching kinetics was found to fit well with the shrinking core models, respectively. These models detailed an appropriate results based on the relative velocity between both solid and liquid properties during leaching steps. Notably, activation energies were determined to be 3.535 kJ/mol for Cu and 2.628 kJ/mol for Ni. Furthermore, four-stage counter-current extraction employing 40% LIX 84-IC at pH 2.5 having O/A ratio of 1/1 resulted in more than 99% copper extraction, with negligible Ni co-extraction leaving nickel in the raffinate. Selective leaching of the leached residue followed by charcoal adsorption and fusion at high temperature was investigated to achieve gold (Au) recovery above 99%. This hydrometallurgical scalability suggests that these processes can be adapted for larger operations; pilot trials, which will help, refine the process and assess its feasibility in a real world, industrial scenario.

Teaching programming through mathematics: the PyGgb platform

We introduce the free web-app PyGgb – the combination of the well-known programming language Python and the dynamic mathematics system GeoGebra. Motivated by the desire to provide an introduction to Python coding in the familiar context of mathematics and geometry, PyGgb allows GeoGebra constructions to be created using Python code. We outline some example use-cases of PyGgb in the classroom. Feedback from pilot trials of PyGgb in online and classroom settings has been positive, and further trials are planned.

A Neonatal Nurse-Controlled Model of Analgesia to Manage Post-Operative Pain in the Surgical Neonate: A Pilot Randomised Controlled Trial.

To test the feasibility and acceptability of a newly developed model of neonatal nurse-controlled analgesia to manage pain in the post-operative infant. The study utilised a single-centre two-arm parallel, unblinded randomised controlled external pilot trial design. The pilot trial was conducted in a surgical neonatal tertiary intensive care unit in Brisbane, Australia. Eligible infants were randomised to receive either post-operative pain management care via a model of neonatal nurse-controlled analgesia or standard care. Feasibility and acceptability were the primary outcomes. Seven feasibility outcomes were assessed by a traffic light system to delineate progression to a larger trial. Acceptability and clinical utility of the model of care by staff were assessed by feedback from an anonymous questionnaire that was administered at the completion of the trial period. Secondary outcomes included parental attitudes and perceptions of post-operative pain management to help establish primary outcomes for a larger randomised controlled trial. Overall staff found the formalised model beneficial for managing post-operative pain but found the complexity of the model and ability to titrate analgesia based only on documented pain scores barriers requiring further consideration. Three of the seven feasibility outcomes failed to reach 'greenlight' targets to progress to a larger trial with adherence to the model, and the proportion of eligible infants not recruited was allocated a 'redlight'. Secondary outcomes were comparable and support future study. This pilot feasibility study has shown that a model of neonatal nurse-controlled analgesia can be safely implemented and utilised in the post-operative care of the surgical neonate. Further exploration of the barriers to model adherence and recruitment is warranted before a future larger trial is undertaken. Though not all primary outcomes reached an acceptable range for further progression, this pilot feasibility study provided invaluable learning and has provided direction for future research into the provision of a family integrated and responsive model of analgesia. This study is reported in line with the Consolidated Standards of Reporting Trials (CONSORT): Extension to randomised pilot and feasibility trial and the TIDieR Checklist (Template for Intervention, Description and Replication). No patient or public contribution was utilised for this study. ACTRN12623000643673-the trial was prospectively registered.

Comparing two caregiver-delivered music listening interventions for community-dwelling people with dementia: A randomised controlled crossover pilot trial.

Objectives: To facilitate access to music-based interventions (MBIs) for people with dementia in the community, it is necessary to develop MBIs that can be used by people with dementia and their informal caregivers at home. In this pilot trial, we aimed to establish whether using slow and fast music of positive valence in a caregiver-delivered MBI results in differential effects. Methods: 17 person-with-dementia-and-caregiver dyads were randomised. Dyads underwent 6-week periods of two music listening interventions, 'MBI A' (consisting of fast, positively valenced music) and 'MBI B' (slow, positively valenced music). The order of these was crossed-over. Half of the dyads also completed a control intervention (6-week care-as-usual). People with dementia listened on tablets or CDs provided. Quantitative assessments included person with dementia outcomes (cognition, well-being, quality of life) and caregiver-reported outcomes (behavioural and psychiatric symptom severity and related distress). Dyads' descriptions of experiences were also recorded. Results: MBI A was associated with superior delayed recall compared to MBI B (MBI A- B: 1.04 [95% CI: 0.16, 1.92], p = .028, Hedge's gav = 0.70). Dyads' descriptions highlight 'in-the-moment' effects of the MBIs. Positive effects of MBI A included heightened mood and movement (e.g. clapping), MBI B was associated with relaxation. Conclusions: The positive effect of MBI A on delayed recall performance suggests that fast, positively valenced music may be explored further to support cognition in people with dementia. Dyads' reports underline the value of music listening to the momentary well-being of people with dementia.

Mixed reality training for medical first responders: system evaluation and recommendations

This study assesses the integration of mixed reality (MR) technologies in medical first responder (MFR) training, focusing on identifying key factors influencing behavioral intention to use MR systems and practical implications for technology acceptance and enhanced realism through haptic feedback. Through a user-centered design approach, involving co-creation workshops, iterative development, and evaluations in pilot and field trials across six countries, this study evaluated technology acceptance, presence, user experience, and workload among MFRs. Both quantitative measures and qualitative feedback were collected to analyze the determinants of technology acceptance and user engagement. The MED1stMR training system, developed as a result, demonstrates that performance expectancy, effort expectancy, and social presence are significant predictors of behavioral intention to use MR training systems among MFRs. High technology acceptance and positive user experience were reported, with specific emphasis on the educational value of haptic feedback in skill training. Trainer feedback highlighted the importance of real-time performance metrics and openness to AI-driven training assistance for enhancing training outcomes. The study underscores the critical role of realistic patient interaction and the importance of aligning training challenges with users’ skills to create engaging MR training environments for MFRs. Identifying factors influencing behavioral intention offers valuable insights for the development of MR training systems, suggesting a focus on social presence and interactive capabilities to improve realism and educational value. The findings advocate for the integration of adaptive training features and further exploration of AI support in scenario optimization and performance enhancement.

Feasibility Testing a Meditation App for Professionals Working With Youth in the Legal System: Protocol for a Hybrid Type 2 Effectiveness-Implementation Pilot Randomized Controlled Trial.

Probation officers and other professionals who work with youth in the legal system often experience high chronic workplace stress, which can contribute over time to elevations in anxiety, depression, and workplace burnout. Emotion dysregulation appears to function as a common mechanism underlying these elevations, and growing evidence suggests it can be improved with mindfulness meditation. Implemented successfully, app-based meditation programs could provide professionals with real-time tools for mitigating the effects of chronic workplace stress. This paper describes the protocol for a hybrid type 2 effectiveness-implementation pilot randomized controlled trial (RCT) of Bodhi AIM+, a meditation app adapted with and for professionals who work with youth in the legal system. The adaptation process and implementation plan, as well as the pilot RCT design, were guided by theoretically driven implementation science frameworks. The primary outcome of the pilot RCT is app adherence (ie, ongoing app usage per objective analytics data). The RCT will be fully remote. Officers and other professionals who work with youth in the legal system (N=50) will be individually randomized to use the meditation app or an active control app matched for time and structure. All participants will be asked to follow a 30-day path of brief audio- or video-guided content and invited to use additional app features as desired. In-app analytics will capture the objective usage of each feature. An adaptive engagement design will be employed to engage nonusers of both apps, whereby analytics data indicating nonuse will trigger additional support (eg, text messages promoting engagement). Mental health outcomes and potential moderators and covariates will be self-reported at baseline, posttest, and 6 months. Participants will also complete 1-week bursts of ecological momentary assessment (EMA) at baseline and over the last week of the intervention to capture the mechanistic target (ie, emotion regulation) in real time. All participants will be invited to complete qualitative posttest interviews. Descriptive statistics will be calculated for quantitative data. Qualitative data will be analyzed using a combined deductive-inductive approach. The quantitative and qualitative data will be incorporated into a mixed methods triangulation design, allowing for the evaluation of app adherence and other implementation outcomes as well as related barriers and facilitators to implementation. Enrollment into the trial started in December 2024 and is currently underway. Study results are anticipated to be available in 2026. Completion of this pilot trial will inform a future, fully powered RCT to formally evaluate the effectiveness and implementation of Bodhi AIM+. Its use of implementation science methods, coupled with digital technology, positions the present study not only to help make meditation tools available to an important workforce at scale but also to inform broader efforts at implementing and evaluating health apps within workplace settings. ClincialTrials.gov NCT06555172; https://clinicaltrials.gov/study/NCT06555172. DERR1-10.2196/71867.