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Occupational BurnoutNCT07028788

Virtual Mindfulness and Breathing Training for Stress, Burnout, Sleep, and Cognition in Rotating-Shift Nurses

A study testing Health Education Material, Mobile-Based Mindfulness and Mobile-Based Mindfulness combined with Breathing in people with Occupational Burnout and Work-Related Stress, run by Chang Shih-Chin.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 65 yearsHealthy volunteers can take part
What is being tested?
Health Education Material, Mobile-Based Mindfulness and Mobile-Based Mindfulness combined with Breathing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
Jul 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Shin-Chin Chang, M.S., Ph.D. Student contact

+886918507906

ssking0918507906@gmail.com

About this study

Official title: 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

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.

Read the detailed description

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:

  1. 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.
  2. Mobile-based Mindfulness Group (MMG): Participants will engage in guided mindfulness practice via a smartphone application, using a pre-recorded 360-degree nature video.
  3. 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.
  4. 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.

Being tested
Health Education Material, Mobile-Based Mindfulness, Mobile-Based Mindfulness combined with Breathing, VR-Based Mindfulness combined with Breathing
Keywords
breathing training, burnout, cognitive function, mindfulness meditation, mobile health, perceived stress, physiological arousal, rotating-shift nurse, sleep quality, virtual reality
Medical subject headings
Burnout, Professional, Occupational Stress, Parasomnias, Cognitive Dysfunction, Burnout, Psychological, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health Education MaterialOther

    Weekly electronic health education handbooks covering nutrition, sleep, shift work, stress awareness, and digital device use.

  • Mobile-Based MindfulnessBehavioural

    Guided mindfulness practice via mobile app using pre-recorded 360° natural environment video.

  • Mobile-Based Mindfulness combined with BreathingBehavioural

    Mindfulness training combined with brief structured breathing exercises via mobile app using 360° nature video.

  • VR-Based Mindfulness combined with BreathingBehavioural

    Virtual reality-delivered mindfulness and structured breathing training using immersive 360° natural environment video.

Study groups in NCT07028788
Study groupRoleWhat they receive
Health Education Control Group(CG)OtherParticipants will receive an 8-week electronic health education handbook covering topics such as healthy eating habits, balanced nutrition, the physiological impact of shift work, sleep schedules for shift workers, the effects of electronic device use on sleep, and identifying sources of stress. The content does not include any components related to mindfulness or breathing exercises.
Receives: Other: Health Education Material
Mobile-based Mindfulness Group (MMG)ExperimentalParticipants will be guided through mindfulness exercises using a pre-recorded 360-degree natural environment video accessed via a mobile application. Participants in the intervention groups will engage in an 8-week program, practicing five times per week, with each session lasting 10 minutes.
Receives: Behavioral: Mobile-Based Mindfulness
mobile-based mindfulness combined with brief structured breathing training group (MMBG)ExperimentalParticipants will be guided through mindfulness combined with brief structured breathing exercises, using a pre-recorded 360-degree nature video delivered through a mobile application. Participants in the intervention groups will engage in an 8-week program, practicing five times per week, with each session lasting 10 minutes.
Receives: Behavioral: Mobile-Based Mindfulness combined with Breathing
Virtual reality-assisted mindfulness combined with brief structured breathing training group (VMBG)ExperimentalParticipants will wear a VR headset and immerse themselves in a natural virtual environment while engaging in mindfulness combined with brief structured breathing exercises. Participants in the intervention groups will engage in an 8-week program, practicing five times per week, with each session lasting 10 minutes.
Receives: Behavioral: VR-Based Mindfulness combined with Breathing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Chinese version of the 10-item Perceived Stress Scale (PSS-10-C )

    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.

    Measured: Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up)

  2. Perceived Stress -Safety Culture Subscale.

    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.

    Measured: Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up)

  3. Nursing Burnout Scale (NBS)

    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.

    Measured: Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up)

Secondary outcomes (6)
  1. Actigraphy-Based Sleep Quality Index

    A composite sleep quality score derived from multiple actigraphy-based parameters including total sleep time, sleep efficiency, number of awakenings, and sleep onset latency. Each parameter will be normalized and weighted based on validated sleep scoring algorithms (e.g., Sadeh algorithm), and then aggregated into a composite index to represent overall sleep quality. Higher scores indicate better sleep.

    Measured: Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up).

  2. Sleep quality. Taiwanese version of the Pittsburgh Sleep Quality Index (PSQI-TC )

    This outcome measure uses the Taiwanese version of the Pittsburgh Sleep Quality Index (PSQI-TC) to evaluate participants' sleep quality. The PSQI-TC includes 19 items across seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is scored from 0 to 3, and total scores range from 0 to 21, with higher scores indicating poorer sleep quality. The scale has demonstrated strong internal consistency, with Cronbach's α ranging from 0.83 to 0.85, and is culturally adapted for use among shift-working nurses in Taiwan.

    Measured: Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up)

  3. Cognitive Function - Visual Pursuit Test (VTS-LVT)

    This test evaluates visual orientation performance and spatial scanning ability under time pressure. The outcome will include accuracy rate and average reaction time (in milliseconds).

    Measured: Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up).

  4. Cognitive Function - Determination Test (VTS-DT)

    This test assesses reactive stress tolerance and decision-making performance under time constraints. The outcome measures include number of errors and average reaction time (in milliseconds).

    Measured: Data will be collected at baseline, 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up).

  5. Cognitive Function - Signal Detection Test (VTS-SDT)

    This test measures sustained attention and the ability to distinguish relevant signals from distractors. Key outcome variables include hit rate, false alarm rate, and attentional stability.

    Measured: Data will be collected at baseline, 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up).

  6. Heart Rate Variability (HRV) Measured via BVP using Thought Technology System

    Heart rate variability (HRV) will be measured non-invasively using the Blood Volume Pulse (BVP) sensor of the Thought Technology system (ProComp Infiniti hardware and BioGraph Infiniti software). HRV data will be collected using photoplethysmography (PPG), and derived from inter-beat intervals (IBI). Analysis will include both time-domain indices (e.g., SDNN, RMSSD) and frequency-domain indices (e.g., LF, HF, LF/HF ratio). The assessment will be conducted in accordance with international standards for HRV evaluation and will reflect both sympathetic and parasympathetic autonomic activity. Participants will undergo HRV assessment at Weeks 0 (baseline), 4, 8, and 12 as part of their stress and recovery evaluation.

    Measured: Baseline (Week 0), Week 4, Week 8, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2025
  2. Study startJul 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of four parallel groups: (1) health education control group, (2) mobile-based mindfulness group, (3) mobile-based mindfulness combined with brief structured breathing group, and (4) virtual reality-assisted mindfulness combined with brief structured breathing group. Each group receives a different non-pharmacologic intervention over an 8-week period. The study follows a parallel assignment model without crossover.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07028788
Sponsor's protocol ID
TSGH-PH_E_114018
Status last verified
Jun 2025
First submitted
18 May 2025
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Health Education Material, Mobile-Based Mindfulness and Mobile-Based Mindfulness combined with Breathing in people with Occupational Burnout and Work-Related Stress, run by Chang Shih-Chin.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shin-Chin Chang, M.S., Ph.D. Student (+886918507906, ssking0918507906@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chinese version of the 10-item Perceived Stress Scale (PSS-10-C ) (time frame: Data will be collected at baseline (pre-intervention), 4 weeks, 8 weeks (post-intervention), and 12 weeks (follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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