XR2ESILIENCE - XR-Based Resilience Training for Stress and Mental Health in Healthcare Workers
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: XR-based Resilience Training, Waitlist Control.
- Кому может быть актуально
- Состояния в реестре: Occupational Stress, Work-Related Stress, Mental Health, Burnout. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Австрия, Хорватия, Германия, Португалия, Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Pragmatic Randomized Controlled Trial Study Protocol: XR2ESILIENCE - Pioneering XR Technology for the Promotion of Resilience and Mental Health of the Healthcare Workforce
Обзор
This study investigates the effectiveness of an extended reality (XR) based resilience training program designed to support the mental health and well-being of nurses working in hospital settings. Nurses are exposed to high emotional, cognitive, and organizational demands and show elevated levels of work-related stress and stress-associated mental health problems. Strengthening resilience and coping capacities is therefore an important preventive approach to support nurses' well-being and sustain quality of care. The study is conducted as a pragmatic randomized controlled trial with a waitlist control group and includes approximately 232 nurses from hospitals in several European countries. Participants are randomly assigned either to an XR-based resilience training group or to a waitlist control group that continues with care as usual during the waiting period. The XR-based intervention consists of eight immersive training sessions delivered over approximately ten weeks using a head-mounted display. The training focuses on behavioral, cognitive, and emotional coping strategies and aims to enhance key resilience factors such as problem-solving, cognitive reappraisal, emotion regulation, and positive self-care. The primary outcome is perceived stress, assessed using the Perceived Stress Scale. Secondary outcomes include resilience, occupational self-efficacy, quality of life, psychological distress, burnout symptoms, coping strategies, work-related rumination, and turnover intentions. Assessments are conducted at baseline, post-intervention, and at a 20-week follow-up. In addition, a subgroup of participants will optionally provide physiological data during selected XR sessions to explore digital biomarkers related to stress and recovery. The findings of this study will provide evidence on the effectiveness, feasibility, and acceptance of XR-based resilience training for nurses and inform future implementation of digital mental health interventions in healthcare workplaces.
Подробное описание
This study is part of the XR2ESILIENCE project, a European multicenter research initiative aimed at promoting resilience and mental health among healthcare professionals through innovative extended reality (XR) technologies. The present randomized controlled trial evaluates the effectiveness of a newly developed XR-based resilience training program for nurses working in hospital settings.
Nurses are frequently exposed to high workload, emotional labor, time pressure, and organizational stressors, which are associated with increased stress levels, burnout symptoms, and mental health impairments. Despite the high relevance of resilience promotion in this occupational group, accessible and scalable preventive interventions remain limited. XR technology offers the opportunity to deliver immersive, engaging, and standardized resilience training that can be flexibly integrated into clinical and non-clinical settings.
The study uses a pragmatic, parallel-group, waitlist-controlled randomized design. A total of approximately 232 nurses aged 18 to 65 years will be recruited across multiple hospital sites in Europe. After completion of baseline assessments and provision of informed consent, participants are randomly allocated in a 1:1 ratio either to the XR-based intervention group or to a waitlist control group. The control group continues with care as usual and receives access to the intervention after the waiting period.
The XR-based resilience training consists of eight sessions delivered over approximately ten weeks using a standalone head-mounted display. Each session lasts around 20 to 30 minutes. The training is structured into modules addressing behavioral coping (e.g., problem-solving and proactive coping), cognitive coping (e.g., appraisal and reappraisal of stressors), and emotional coping (e.g., emotion regulation, acceptance, and fostering positive emotions). The intervention is theoretically grounded in contemporary resilience frameworks and the concept of regulatory flexibility. Participants complete the sessions individually, with technical support available if needed.
The primary outcome is perceived stress measured by the 10-item Perceived Stress Scale at post-intervention. Secondary outcomes include resilience, occupational self-efficacy, psychological distress, burnout symptoms, coping strategies, work-related rumination, quality of life, and career-related variables such as turnover intentions. Data are collected at baseline, immediately after the intervention period, and at a 20-week follow-up.
In addition to questionnaire-based outcomes, optional digital biomarker data are collected during selected XR sessions to explore physiological indicators of stress and recovery, such as heart rate variability and other sensor-based measures, depending on study site capabilities. User experience, technology acceptance, satisfaction, and potential side effects of XR use are assessed descriptively after completion of the intervention.
The study follows an intention-to-treat approach for primary analyses. Results are expected to provide robust evidence on whether XR-based resilience training can reduce perceived stress and improve mental health outcomes among nurses. The findings will also inform the feasibility, acceptability, and potential health-economic value of implementing XR-supported resilience interventions in hospital workplaces.
Вмешательства
- Поведенческое XR-based Resilience Training
The XR-based resilience training is delivered via a standalone extended reality head-mounted display and consists of eight immersive sessions over approximately ten weeks. The training addresses behavioral coping strategies such as problem solving, cognitive coping strategies such as appraisal and reappraisal of stressors, and emotional coping strategies including emotion regulation and positive self-care. Sessions last approximately 20 to 30 minutes and are completed individually with technical - Другое Waitlist Control
Participants assigned to the waitlist control condition receive no active intervention during the initial study period and continue with care as usual. After completion of the post-intervention assessment, participants are offered access to the XR-based resilience training.
Первичные конечные точки
- Perceived Stress Assessed by PSS-10 [Срок оценки: Baseline, 10 weeks post-randomization & 20 weeks post-randomization]
Вторичные конечные точки (12)
- Resilience Assessed by BRS [Срок оценки: Baseline, 10 weeks post-randomization & 20 weeks post-randomization]
- Occupational Self-Efficacy Assessed by OSE-SF [Срок оценки: Baseline and 10 weeks post-randomization]
- Psychological Distress Assessed by GHQ-12 [Срок оценки: Baseline and 10 weeks post-randomization]
- Burnout symptoms Assessed by BAT-12 [Срок оценки: Baseline and 10 weeks post-randomization]
- Coping Strategies Assessed by CSI-SF [Срок оценки: Baseline, 10 weeks post-randomization & 20 weeks post-randomization]
- Coping Flexibility Assessed by CFS-R [Срок оценки: Baseline, 10 weeks post-randomization & 20 weeks post-randomization]
- Health-Related Quality of Life Assessed by EQ-5D-5L [Срок оценки: Baseline and 10 weeks post-randomization]
- Turnover intentions [Срок оценки: Baseline and 10 weeks post-randomization]
- User Experience Assessed With the AttrakDiff Mini [Срок оценки: 10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)]
- User Satisfaction Assessed With the Client Satisfaction Questionnaire for Internet-Based Interventions [Срок оценки: 10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)]
- VR-Related Side Effects Assessed With the Virtual Reality Neuroscience Questionnaire [Срок оценки: 10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)]
- Positive Effects Assessed With Adapted Items From the Oxford VR Side Effects Checklist [Срок оценки: 10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group)]
Критерии участия
Критерии включения
- working as a nurse in direct patient care within a clinical setting;
- working at least 10h/week in their profession;
- speaking the language in which the RCT is conducted sufficiently well;
- able and willing to participate in all aspects of the study;
- understanding and signing the appropriate informed consent form.
Критерии исключения
- a diagnosed severe mental disorder associated with alterations in reality perception (e.g., delusions, hallucinations, derealization, depersonalization, or dementia), including in particular schizophrenia, bipolar disorder, severe major depressive disorder, or other psychotic disorders (lifetime);
- a current major depressive episode or a current post-traumatic stress disorder (PTSD);
- an acute or clinically significant medical condition that may interfere with the safe use of an XR headset or study participation, including but not limited to epilepsy, pronounced dizziness, balance disorders, or acute cardiovascular conditions;
- an acute eye infection (e.g., conjunctivitis);
- unstable medication related to a mental health condition, defined as recent changes in dosage or class of psychotropic medication;
- initiation of psychotherapy or any structured stress-management training within the past three months.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Профилактика
Центры проведения
Испания · 4 центра
- Del Henares University Hospital — Coslada
- Summa 112 — Madrid
- Infanta Leonor University Hospital — Madrid
- Infanta Sofía University Hospital — San Sebastián de los Reyes
Австрия · 1 центр
- Medical University of Graz, Clinical Division of Psychiatry and Psychotherapeutic Medicine — Graz
Хорватия · 1 центр
- Klinika za psihijatriju Sveti Ivan — Zagreb
Германия · 1 центр
- University Medical Center of Johannes Gutenberg University Mainz — Mainz
Португалия · 1 центр
- Hospital José Joaquim Fernandes — Beja
Идентификаторы
NCT: NCT07544498 · 101137237 · 101137237