Personalized Virtual Reality Compared With Guided Imagery for Enhancing the Impact of Progressive Muscle Relaxation Training: Pilot Randomized Controlled Trial.

BACKGROUND: Empirical evidence has shown that virtual reality (VR) scenarios can increase the effects of relaxation techniques, reducing anxiety by enabling people to experience emotional conditions in more vivid settings. OBJECTIVE: This pilot randomized controlled study aims to investigate whether the progressive muscle relaxation technique (PMRT) associated with a personalized scenario in VR promotes psychological well-being and facilitates the recall of relaxing images more than the standard complementary intervention that involves the integration of PMRT and guided imagery (GI). METHODS: On the basis of a longitudinal, between-subject design, 72 university students were randomly exposed to one of two experimental conditions: (1) standard complementary procedure (PMRT and GI exposure) and (2) experimental procedure (PMRT and personalized VR exposure). Individuals were assessed by a therapist before and after 7 training sessions based on measures investigating anxiety, depression, quality of life, coping strategies, sense of presence, engagement, and side effects related to VR exposure. Heart rate data were also collected. RESULTS: Differences in changes between the 2 groups after the in vivo PMRT session conducted by the psychotherapist (T1) were statistically significant for state anxiety (F1,67=30.56; P<.001) and heart rate (F1,67=4.87; P=.01). Individuals in the VR group obtained lower scores both before (t67=-2.63; P=.01; Cohen d=0.91) and after (t67=-7.23; P<.001; Cohen d=2.45) the relaxation session when it was self-administered by participants (T2). A significant reduction in perceived state anxiety at T1 and T2 was observed for both groups (P<.001). After the VR experience, individuals reported feeling higher engagement in the experience than what was mentioned by participants in the GI group (F1,67=2.85; P=.03; ηp2=0.15), and they experienced the environment as more realistic (F1,67=4.38; P=.003; ηp2=0.21). No differences between groups regarding sense of presence were found (F1,67=1.99; P=.11; ηp2=0.11). Individuals exposed before to the VR scenario (T1) referred to perceiving the scenario recalled in-imagination at T2 as more realistic than what those in the GI group experienced (F1,67=3.21; P=.02; ηp2=0.12). The VR group had lower trait anxiety levels than the GI group after the relaxation session during session 7 (T2; t67=-2.43; P=.02). CONCLUSIONS: Personalized relaxing VR scenarios can contribute to improving relaxation and decreasing anxiety when integrated with PMRT as a complementary relaxation method. TRIAL REGISTRATION: ClinicalTrials.gov NCT05478941; https://classic.clinicaltrials.gov/ct2/show/NCT05478941. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/44183.

Co-Design of a Virtual Reality Multiplayer Adventure Game for Adolescents With Autism Spectrum Disorder: Mixed Methods Study.

BACKGROUND: Virtual reality (VR) adventure games can offer ideal technological solutions for training social skills in adolescents with autism spectrum disorder (ASD), leveraging their support for multisensory and multiplayer interactions over distance, which may lower barriers to training access and increase user motivation. However, the design of VR-based game environments for social skills training is still understudied and deserves the deployment of an inclusive design approach to ensure its acceptability by target users. OBJECTIVE: We aimed to present the inclusive design process that we had followed to develop the Zentastic VR adventure game to foster social skills training in adolescents with ASD and to investigate its feasibility as a training environment for adolescents. METHODS: The VR game supports multiplayer training sessions involving small groups of adolescents and their therapists, who act as facilitators. Adolescents with ASD and their therapists were involved in the design and in an explorative acceptability study of an initial prototype of the gaming environment, as well as in a later feasibility multisession evaluation of the VR game final release. RESULTS: The feasibility study demonstrated good acceptability of the VR game by adolescents and an enhancement of their social skills from baseline to posttraining. CONCLUSIONS: The findings provide preliminary evidence of the benefits that VR-based games can bring to the training of adolescents with ASD and, potentially, other neurodevelopmental disorders.

Customized virtual reality naturalistic scenarios promoting engagement and relaxation in patients with cognitive impairment: a proof-of-concept mixed-methods study.

Being immersed in a natural context has a beneficial and pervasive impact on well-being. Virtual Reality (VR) is a technology that can help expose people to naturalistic scenarios virtually, overcoming obstacles that prevent them from visiting real natural environments. VR could also increase engagement and relaxation in older adults with and without cognitive impairment. The main aim of this study is to investigate the feasibility of a customized naturalistic VR scenario by assessing motion-sickness effects, engagement, pleasantness, and emotions felt. Twenty-three individuals with a diagnosis of cognitive impairment living in a long-term care home participated in our study. At the end of the entire VR experimental procedure with older adults, five health staff operators took part in a dedicated assessment phase focused on evaluating the VR procedure's usability from their individual perspectives. The tools administered were based on self-reported and observational tools used to obtain information from users and health care staff professionals. Feasibility and acceptance proved to be satisfactory, considering that the VR experience was well-tolerated and no adverse side effects were reported. One of the major advantages emerged was the opportunity to deploy customized environments that users are not able to experience in a real context.Trial Registration: National Institute of Health (NIH) U.S. National Library of Medicine, ClinicalTrials.gov NCT05863065 (17/05/2023).

Personalized, Naturalistic Virtual Reality Scenarios Coupled With Web-Based Progressive Muscle Relaxation Training for the General Population: Protocol for a Proof-of-Principle Randomized Controlled Trial.

BACKGROUND: Virtual reality (VR) is an innovative tool that can facilitate exposure to either stressful or relaxing stimuli and enables individuals who have difficulties visualizing scenes to be involved in a more realistic sensorimotor experience. It also facilitates multisensory stimulation, a sense of presence, and achievement of relaxation. VR scenarios representing visual and auditory elements of natural relaxing environments can facilitate the learning of relaxation techniques such as the progressive muscle relaxation technique (PMRT). A complementary standardized technique deployed to reduce anxiety symptoms is the integration of PMRT and guided imagery (GI). Exposure to a pleasant imaginary environment helps the establishment of an association between a relaxing scenario and the relaxation technique, consequently promoting relaxation. Empirical evidence has shown that VR scenarios can increase the effects of relaxation techniques by enabling people to experience emotional conditions in more vivid settings. OBJECTIVE: The main aim of this pilot study protocol is to investigate the impact on state anxiety of PMRT, associated with a personalized relaxing scenario in VR, and the role of VR scenarios in facilitating the recall of relaxing images and a sense of presence. A secondary aim is to understand if relaxing sessions administered via Zoom are more effective for managing anxiety and stress than a procedural setting based on audio-track guidance. METHODS: Based on a longitudinal, between-subject design, 108 university students will be randomly exposed to one of three experimental conditions: (1) PMRT via Zoom and GI exposure, (2) PMRT via Zoom and personalized VR exposure, and (3) PMRT based on audio-track guidance and personalized VR exposure. Individuals are assessed before and after 7 training sessions based on self-report questionnaires investigating anxiety, depression, quality of life, coping strategies, sense of presence, engagement, and side effects related to VR exposure. Heart rate data are also detected by an Mi Band 2 sensor. RESULTS: The experimental procedure is ongoing. In this paper, preliminary data from a sample of 40 participants will be illustrated. The experimental phase is expected to conclude in May 2023, and the final results of the research will be presented in June 2023. CONCLUSIONS: The results of this study will help shape the experimental design to apply it on a subsequent randomized controlled trial, also considering clinical samples. This work is expected to measure whether VR is a more engaging and helpful technique in promoting relaxation and decreasing anxiety levels than GI, by making the visualization process easier and by helping people to face more realistic sensory experiences. Assessing the efficacy of the PMRT in alternative delivery modes may extend its applications, especially in situations where the standard procedure is more challenging to be administered. To our knowledge, no equivalent study has been published so far on this matter. TRIAL REGISTRATION: ClinicalTrials.gov NCT05478941; https://clinicaltrials.gov/ct2/show/NCT05478941. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44183.

The Role of Personalization in the User Experience, Preferences and Engagement with Virtual Reality Environments for Relaxation.

Virtual Reality Environments (VREs) are widely deployed in mental health treatments, often associated with relaxation techniques. The personalization of natural VR-based scenarios is a key element that can further facilitate users' sense of presence and relaxation. This study explored the role of VREs' personalization in the user experience with an environment supporting relaxation, by deploying mixed methods. METHODS: A non-clinical sample of 20 individuals participated in exposure to a supportive body-scan-guided relaxation VRE. In the personalized conditions, the participants had the option of choosing the context (e.g., sea, mountain, or countryside) and including in the scenario different types of sounds, visual elements, and changing the time of day and weather. In the standard conditions, individuals were exposed to a relaxing VRE, but they could choose neither the context nor the auditory and visual elements. The order of presentation of the personalized vs non-personalized environments was randomized. Measures regarding relaxation, state-anxiety perceived levels, VRE-related symptoms, the usability of the Virtual Reality (VR) setting, sense of presence, pleasure, activation, engagement, and level of immersion experienced were collected before and after exposure to the VR environments. RESULTS: Findings showed that personalized VREs were preferred by users. Participants generally preferred to experience a greater immersivity, pleasure, engagement, and relaxation in the personalized virtual settings. CONCLUSION: The study further confirms the role of personalization as a component positively contributing to relaxation and engagement. Future research may further assess this effect in the context of large-scale controlled studies involving clinical and non-clinical populations.

A Remote Monitoring System to Optimize the Home Management of Oral Anticancer Therapies (ONCO-TreC): Prospective Training-Validation Trial.

BACKGROUND: A platform designed to support the home management of oral anticancer treatments and provide a secure web-based patient-health care professional communication modality, ONCO-TreC, was tested in 3 cancer centers in Italy. OBJECTIVE: The overall aims of the trial are to customize the platform; assess the system's ability to facilitate the shared management of oral anticancer therapies by patients and health professionals; and evaluate system usability and acceptability by patients, caregivers, and health care professionals. METHODS: Patients aged ≥18 years who were candidates for oral anticancer treatment as monotherapy with an Eastern Cooperative Oncology Group performance status score of 0 to 1 and a sufficient level of familiarity with mobile devices were eligible. ONCO-TreC consisted of a mobile app for patients and a web-based dashboard for health care professionals. Adherence to treatment (pill count) and toxicities reported by patients through the app were compared with those reported by physicians in medical records. Usability and acceptability were evaluated using questionnaires. RESULTS: A total of 40 patients were enrolled, 38 (95%) of whom were evaluable for adherence to treatment. The ability of the system to measure adherence to treatment was high, with a concordance of 97.3% (95% CI 86.1%-99.9%) between the investigator and system pill count. Only 60% (3/5) of grade 3, 54% (13/24) of grade 2, and 19% (7/36) of grade 1 adverse events reported by physicians in the case report forms were also reported in the app directly by patients. In total, 94% (33/35) of patients had ≥1 app launch each week, and the median number of daily accesses per patient was 2. Approximately 71% (27/38) and 68% (26/38) of patients used the app for messages and vital sign entering, respectively, at least once during the study period. CONCLUSIONS: ONCO-TreC is an important tool for measuring and monitoring adherence to oral anticancer drugs. System usability and acceptability were very high, whereas its reliability in registering toxicity could be improved. TRIAL REGISTRATION: ClinicalTrials.gov NCT02921724; https://www.clinicaltrials.gov/ct2/show/NCT02921724.

Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial.

INTRODUCTION: ONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours. METHODS AND ANALYSIS: This is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher's exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs. ETHICS AND DISSEMINATION: Ethical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. PROTOCOL VERSION: Version 2, 6 April 2021. TRIAL REGISTRATION NUMBER: NCT04826458.

Enabling teleophthalmology during the COVID-19 pandemic in the Province of Trento, Italy: Design and implementation of a mHealth solution.

BACKGROUND: Due to the many restrictions imposed during the COVID-19 emergency, the normal clinical activities have been stopped abruptly in view of limiting the circulation of the virus. The extraordinary containment measures have had a dramatic impact on the undertaking and follow-up of ophthalmic outpatients. OBJECTIVE: In order to guarantee proper monitoring and routine care, the Pediatric Ophthalmology equipe of Rovereto Hospital (North-East of Italy) supported by the Competence Center on Digital Health TrentinoSalute4.0, designed and implemented a digital platform, TreC Oculistica, enabling teleophthalmology. We report our innovative-albeit restricted-experience aiming at testing and maximizing the efficacy of remote ophthalmic and orthoptic visits. METHODS: A multidisciplinary team created the TreC Oculistica platform and defined a teleophthalmology protocol. The system consists of a clinician web interface and a patient mobile application. Clinicians can prescribe outpatients with the App and some preliminary measurements to be self-collected before the televisit. The App conveys the clinician's requests (i.e. measurements) and eases the share of the collected information in a secure digital environment, promoting a new health care workflow. RESULTS: Four clinicians took part in the testing phase (2 ophthalmologists and 2 orthoptists) and recruited 37 patients (mostly pediatric) in 3 months. Thanks to a continuous feedback between the testing and the technical implementation, it has been possible to identify pros and cons of the implemented functionalities, considering possible improvements. Digital solutions such as TreC Oculistica advance the digitalization of the Italian health care system, promoting a structured and effective reorganization of the workload supported by digital systems. CONCLUSIONS: The study tested an innovative digital solution in the teleophthalmology context and represented the first experience within the Italian healthcare system. This solution opens up new possibilities and scenarios that can be effective not only during the pandemic, but also in the traditional management of public health services.

Using Geocaching to Promote Active Aging: Qualitative Study.

BACKGROUND: Over the past few years, the development of technologies supporting active aging has been increasing. Among the activities that promote physical exercise by using technologies is geocaching-a treasure hunt of sorts in which participants use a receiver GPS to hide or find real or virtual objects. Although this activity is particularly suited to the promotion of healthy lifestyles in older people, geocaching remains to be unexplored in this area. OBJECTIVE: This study aimed to investigate the effectiveness of activities combining geocaching and self-tracking technologies to promote active aging, evaluate the usability of technologies, and explore the ways in which technologies have been integrated in the organizational context under examination to determine the user experience of participants. METHODS: A group of individuals aged 65 years and older (N=14) attending a senior center managed by a social cooperative was involved in the study. Some of them created the geocaching contents, and others, split into 2 teams, participated in the game. Each participant was given a pedometer bracelet and the geocaching app. The steps taken by individual participants along with the number of caches found by each group translated into team scores. RESULTS: The main results of the study were as follows: (1) activities in favor of active aging that involve the use of new technologies can foster the participation of elderly people; in particular, adding gamification to self-tracking can be a valid strategy to promote physical exercise among the elderly; (2) for this to happen, involvement of older people firsthand is crucial, and there must be a focus on their active involvement and empowerment in every phase of the project; and (3) the mediation of conflicts and competition that arise from the gamification could only take place because of the strong support of the organization in the form of social workers. CONCLUSIONS: The results show that promoting active aging through technologies requires more effort than simply using these tools; it requires a wider process that involves an articulated organizational network with heterogeneous actors, technologies, and relations.

Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study.

INTRODUCTION: Despite the growing number of oral agents available for cancer treatment, their efficacy may be reduced due to the lack of adherence, inappropriate adverse event self-management and arbitrary dose adjustment. The management of anticancer therapies could exponentially benefit from the introduction of mobile health technologies in a highly integrated electronic oncology system. METHODS AND ANALYSIS: We plan to customise and fine-tune an existing monitoring TreC platform used in different chronic diseases in the oncology setting. This project follows a multistep approach with two major purposes: 1. participatory design techniques driven by Health Literacy and Patient Reported Outcomes principles in order to adapt the system to the oncology setting involving patients and healthcare providers; 2. a prospective training-validation, interventional, non-pharmacological, multicentre study on a series of consecutive patients with cancer (20 and 60 patients in the training and validation steps, respectively) in order to assess system capability, usability and acceptability. The novel Onco-TreC 2.0 is expected to contribute to improving the adherence and safety of cancer care, promoting patient empowerment and patient-doctor communication. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Independent Ethics Committees of the participating institutions (CEIIAV protocol Number 2549/2015; reference Number 1315-PU). Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT02921724); (Pre-results). Other study ID Number: IRST100.18.

Design of a Mobile App for Nutrition Education (TreC-LifeStyle) and Formative Evaluation With Families of Overweight Children.

BACKGROUND: Nutrition and diet apps represent today a popular area of mobile health (mHealth), offering the possibility of delivering behavior change (BC) interventions for healthy eating and weight management in a scalable and cost-effective way. However, if commercial apps for pediatric weight management fail to retain users because of a lack of theoretical background and evidence-based content, mHealth apps that are more evidence-based are found less engaging and popular among consumers. Approaching the apps development process from a multidisciplinary and user-centered design (UCD) perspective is likely to help overcome these limitations, raising the chances for an easier adoption and integration of nutrition education apps within primary care interventions. OBJECTIVE: The aim of this study was to describe the design and development of the TreC-LifeStyle nutrition education app and the results of a formative evaluation with families. METHODS: The design of the nutrition education intervention was based on a multidisciplinary UCD approach, involving a team of BC experts, working with 2 nutritionists and 3 pediatricians from a primary care center. The app content was derived from evidence-based knowledge founded on the Food Pyramid and Mediterranean Diet guidelines used by pediatricians in primary care. A formative evaluation of the TreC-LifeStyle app involved 6 families of overweight children (aged 7-12 years) self-reporting daily food intake of children for 6 weeks and providing feedback on the user experience with the mHealth intervention. Analysis of the app's usage patterns during the intervention and of participants' feedback informed the refinement of the app design and a tuning of the nutrition education strategies to improve user engagement and compliance with the intervention. RESULTS: Design sessions with the contribution of pediatricians and nutritionists helped define the nutrition education app and intervention, providing an effective human and virtual coaching approach to raise parents' awareness about children's eating behavior and lifestyle. The 6 families participating in the pilot study found the app usable and showed high compliance with the intervention over the 6 weeks, but analysis of their interaction and feedback showed the need for improving some of the app features related to the BC techniques "monitoring of the behavior" and "information provision." CONCLUSIONS: The UCD and formative evaluation of TreC-LifeStyle show that nutrition education apps are feasible and acceptable solutions to support health promotion interventions in primary care.

Integrating mHealth in Oncology: Experience in the Province of Trento.

BACKGROUND: The potential benefits of the introduction of electronic and mobile health (mHealth) information technologies, to support the safe delivery of intravenous chemotherapy or oral anticancer therapies, could be exponential in the context of a highly integrated computerized system. OBJECTIVE: Here we describe a safe therapy mobile (STM) system for the safe delivery of intravenous chemotherapy, and a home monitoring system for monitoring and managing toxicity and improving adherence in patients receiving oral anticancer therapies at home. METHODS: The STM system is fully integrated with the electronic oncological patient record. After the prescription of chemotherapy, specific barcodes are automatically associated with the patient and each drug, and a bedside barcode reader checks the patient, nurse, infusion bag, and drug sequence in order to trace the entire administration process, which is then entered in the patient's record. The usability and acceptability of the system was investigated by means of a modified questionnaire administered to nurses. The home monitoring system consists of a mobile phone or tablet diary app, which allows patients to record their state of health, the medications taken, their side effects, and a Web dashboard that allows health professionals to check the patient data and monitor toxicity and treatment adherence. A built-in rule-based alarm module notifies health care professionals of critical conditions. Initially developed for chronic patients, the system has been subsequently customized in order to monitor home treatments with capecitabine or sunitinib in cancer patients (Onco-TreC). RESULTS: The STM system never failed to match the patient/nurse/drug sequence association correctly, and proved to be accurate and reliable in tracing and recording the entire administration process. The questionnaires revealed that the users were generally satisfied and had a positive perception of the system's usefulness and ease of use, and the quality of their working lives. The pilot studies with the home monitoring system with 43 chronic patients have shown that the approach is reliable and useful for clinicians and patients, but it is also necessary to pay attention to the expectations that mHealth solutions may raise in users. The Onco-TreC version has been successfully laboratory tested, and is now ready for validation. CONCLUSIONS: The STM and Onco-TreC systems are fully integrated with our complex and composite information system, which guarantees privacy, security, interoperability, and real-time communications between patients and health professionals. They need to be validated in order to confirm their positive contribution to the safer administration of anticancer drugs.