Effectiveness of Virtual Mindfulness Combined With Brief Structured Breathing Training on Perceived Stress, Burnout, Sleep Quality, and Cognitive Function Among Rotating-Shift Nurses: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Chinese version of the 10-item Perceived Stress Scale (PSS-10-C )
研究概览
简要总结
This randomized controlled trial aims to evaluate the effectiveness of a mobile- and virtual reality-based mindfulness and breathing intervention on stress, burnout, sleep quality, and cognitive function among Rotating-shift nurses. Participants will be randomly assigned to one of four groups: (1) health education control group, (2) mobile-based mindfulness only, (3) mobile-based mindfulness combined with brief structured breathing, and (4) virtual reality-assisted mindfulness combined with brief structured breathing. The intervention will last for 8 weeks, with participants practicing 5 times per week for 10 minutes per session. Primary outcomes include perceived stress, burnout levels, sleep quality, and cognitive function.
详细描述
Rotating-shift nurses often experience high levels of chronic stress, occupational burnout, and disrupted sleep patterns, which can negatively affect their cognitive function and well-being. This study aims to investigate the effectiveness of technology-assisted mindfulness and breathing interventions in addressing these issues.
A total of four groups will be included in this randomized controlled trial:
- Control Group (CG): Participants will receive a weekly electronic health education manual for 8 weeks. Topics include healthy eating habits, balanced nutrition, the physiological impact of shift work, sleep hygiene for shift workers, the effects of electronic devices on sleep, and identifying sources of stress. No mindfulness or breathing content is included.
- Mobile-based Mindfulness Group (MMG): Participants will engage in guided mindfulness practice via a smartphone application, using a pre-recorded 360-degree nature video.
- Mobile-based Mindfulness with Breathing Group (MMBG): Participants will follow a similar protocol as MMG, with the addition of brief structured breathing exercises embedded in the training.
- Virtual Reality-based Mindfulness with Breathing Group (VMBG): Participants will wear a VR headset and immerse themselves in a virtual nature setting while engaging in combined mindfulness and structured breathing training. All intervention groups will complete 10-minute sessions, five times per week, for a total of eight weeks.
Primary outcome measures include: Perceived stress (Perceived Stress Scale, PSS-10-C), Occupational burnout (Nursing Burnout Scale), Sleep quality (Pittsburgh Sleep Quality Index, PSQI) and Cognitive function (including attention and memory tasks). Assessments will be conducted at baseline, immediately post-intervention, and at follow-up. This study will provide insights into the comparative effectiveness of mobile and immersive digital interventions for improving mental health and physiological functioning in Rotating-shift nurses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label trial. Due to the nature of the behavioral interventions and the use of virtual reality or mobile devices, participants and implementers are aware of the assigned group. However, outcome assessors and data analysts will be blinded to group allocation to reduce assessment bias.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 20 and 65 years.
- •Able to understand spoken or written Mandarin or Taiwanese.
- •Employed full-time for at least 3 months with a signed employment contract.
- •Has worked rotating shifts (including day, evening, and/or night shifts) in the past 3 months.
- •Willing to participate and sign informed consent.
- •Registered nurse.
- •A perceived stress score greater than or equal to 50 based on a standardized scale.
排除标准
- •Pregnant or breastfeeding individuals.
- •History of substance abuse (e.g., tobacco, illicit drugs).
- •Alcohol consumption ≥350 ml/week with alcohol content ≥3.5%.
- •Diagnosed or suspected autonomic nervous system disorders.
- •History of severe or unstable cardiovascular disease, cerebrovascular disease, cancer, or end-stage organ failure within the past 6 months.
- •Current diagnosis of psychiatric disorders (e.g., major depressive disorder, schizophrenia), or use of psychiatric or sleep medications (e.g., antidepressants, sedatives).
- •Reported discomfort (e.g., dizziness, nausea) when using virtual reality devices.
- •Engaged in other regular exercise programs, light therapy, or mind-body interventions during the study period.
- •Participating in other clinical trials simultaneously.
结局指标
主要结局
Chinese version of the 10-item Perceived Stress Scale (PSS-10-C )
时间窗: Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up)
This scale assesses how unpredictable, uncontrollable, and overloaded individuals perceive their lives to be. It contains two subscales: perceived helplessness and perceived self-efficacy. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (very often). The scale has demonstrated high internal consistency (Cronbach's α = 0.85) and good test-retest reliability (r = 0.66, p \< 0.001) over three months in Chinese-speaking nursing samples.
Perceived Stress -Safety Culture Subscale.
时间窗: Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up)
This measure uses the "Perception of Stress" subscale from the Taiwan version of the Safety Attitudes Questionnaire (SAQ), which includes four items that assess healthcare professionals' awareness of stress and its effects on performance. One item is reverse-coded. Items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Subscale scores are transformed to a 0-100 scale using the formula: Transformed score = (mean score - 1) × 25. Higher scores indicate greater perceived stress. This transformation supports standardization and enables comparison across domains.
Nursing Burnout Scale (NBS)
时间窗: Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up)
This scale was developed for clinical nurses and evaluates emotional exhaustion, reduced personal accomplishment, and depersonalization. It includes 12 items across three subscales, with four items per subscale. Each item is rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The total scale has demonstrated high internal consistency (Cronbach's α = 0.92) and acceptable subscale reliability (Cronbach's α = 0.64-0.86), indicating good psychometric properties for use among nursing professionals.
次要结局
- Actigraphy-Based Sleep Quality Index(Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up).)
- Sleep quality. Taiwanese version of the Pittsburgh Sleep Quality Index (PSQI-TC )(Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up))
- Cognitive Function - Visual Pursuit Test (VTS-LVT)(Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up).)
- Cognitive Function - Determination Test (VTS-DT)(Data will be collected at baseline, 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up).)
- Cognitive Function - Signal Detection Test (VTS-SDT)(Data will be collected at baseline, 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up).)
- Heart Rate Variability (HRV) Measured via BVP using Thought Technology System(Baseline (Week 0), Week 4, Week 8, Week 12)
研究者
Chang Shih-Chin
Principal Investigator, School of Nursing, National Defense Medical Center
National Defense Medical Center, Taiwan