A Pragmatic Randomized Controlled Trial Study Protocol: XR2ESILIENCE - Pioneering XR Technology for the Promotion of Resilience and Mental Health of the Healthcare Workforce
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 232
- 试验地点
- 8
- 主要终点
- Perceived Stress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an open-label trial. Due to the nature of the XR-based intervention and the waitlist control design, blinding of participants and study personnel is not feasible.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
XR-based Resilience Training
Participants in this arm receive an XR-based resilience training consisting of eight immersive sessions delivered over approximately ten weeks using a head-mounted display. The training focuses on behavioral, cognitive, and emotional coping strategies and aims to strengthen resilience and stress management skills. Each session lasts approximately 20 to 30 minutes and is completed individually.
干预措施: Waitlist Control (Other)
XR-based Resilience Training
Participants in this arm receive an XR-based resilience training consisting of eight immersive sessions delivered over approximately ten weeks using a head-mounted display. The training focuses on behavioral, cognitive, and emotional coping strategies and aims to strengthen resilience and stress management skills. Each session lasts approximately 20 to 30 minutes and is completed individually.
干预措施: XR-based Resilience Training (Behavioral)
Waitlist Control
Participants in this arm are assigned to a waitlist control condition and continue with care as usual during the waiting period. They do not receive the XR-based resilience training during the first ten weeks of the study but are offered access to the intervention after completion of the post-intervention assessment.
结局指标
主要结局
Perceived Stress
时间窗: Baseline and 10 weeks post-randomization
Perceived stress measured using the 10-item Perceived Stress Scale (PSS-10). The PSS-10 assesses the degree to which situations in one's life are appraised as stressful during the past month. Scores range from 0 to 40, with higher scores indicating higher perceived stress.
Perceived Stress Assessed by PSS-10
时间窗: Baseline, 10 weeks post-randomization & 20 weeks post-randomization
Perceived stress measured using the 10-item Perceived Stress Scale (PSS-10). The PSS-10 assesses the degree to which situations in one's life are appraised as stressful during the past month. Scores range from 0 to 40, with higher scores indicating higher perceived stress.
次要结局
- Resilience(Baseline, 10 weeks post-randomization and 20 weeks post-randomization)
- Occupational self-efficacy(Baseline and 10 weeks post-randomization)
- Psychological distress(Baseline and 10 weeks post-randomization)
- Burnout symptoms(Baseline 10 weeks post-randomization and 20 weeks post-randomization)
- Coping strategies(Baseline 10 weeks post-randomization and 20 weeks post-randomization)
- Health-related quality of life(Baseline 10 weeks post-randomization and 20 weeks post-randomization)
- Turnover intentions(Baseline 10 weeks post-randomization and 20 weeks post-randomization)
- User Experience and Technology Acceptance(10 weeks post-randomization)
- Resilience Assessed by BRS(Baseline, 10 weeks post-randomization & 20 weeks post-randomization)
- Occupational Self-Efficacy Assessed by OSE-SF(Baseline and 10 weeks post-randomization)
- Psychological Distress Assessed by GHQ-12(Baseline and 10 weeks post-randomization)
- Burnout symptoms Assessed by BAT-12(Baseline and 10 weeks post-randomization)
- Coping Strategies Assessed by CSI-SF(Baseline, 10 weeks post-randomization & 20 weeks post-randomization)
- Coping Flexibility Assessed by CFS-R(Baseline, 10 weeks post-randomization & 20 weeks post-randomization)
- Health-Related Quality of Life Assessed by EQ-5D-5L(Baseline and 10 weeks post-randomization)
- Turnover intentions(Baseline and 10 weeks post-randomization)
- User Experience Assessed With the AttrakDiff Mini(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(10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group))
- VR-Related Side Effects Assessed With the Virtual Reality Neuroscience Questionnaire(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(10 weeks post-randomization (Training Group) or 20 weeks post-randomization (Control Group))