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

NCT07028788 | Not Yet Recruiting

• 1 other identifier: TSGH-PH_E_114018
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Cognitive Dysfunction; Shift Work Disorder; Sleep Disturbance; Occupational Burnout; Work-Related Stress

Keywords

breathing training; burnout; cognitive function; mindfulness meditation; mobile health; perceived stress; physiological arousal; rotating-shift nurse; sleep quality; virtual reality

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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.

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

Secondary Outcomes (6)

• 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).

Other Outcomes (1)

• Blood Pressure Monitoring Device - Omron HEM-907XL

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

Study Arms (4)

Health Education Control Group(CG)

OTHER

Participants 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.

Other: Health Education Material

Mobile-based Mindfulness Group (MMG)

EXPERIMENTAL

Participants 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.

Behavioral: Mobile-Based Mindfulness

mobile-based mindfulness combined with brief structured breathing training group (MMBG)

EXPERIMENTAL

Participants 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.

Behavioral: Mobile-Based Mindfulness combined with Breathing

Virtual reality-assisted mindfulness combined with brief structured breathing training group (VMBG)

EXPERIMENTAL

Participants 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.

Behavioral: VR-Based Mindfulness combined with Breathing

Interventions

Health Education Material OTHER

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

Health Education Control Group(CG)

Mobile-Based Mindfulness BEHAVIORAL

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

Mobile-based Mindfulness Group (MMG)

Mobile-Based Mindfulness combined with Breathing BEHAVIORAL

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

mobile-based mindfulness combined with brief structured breathing training group (MMBG)

VR-Based Mindfulness combined with Breathing BEHAVIORAL

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

Virtual reality-assisted mindfulness combined with brief structured breathing training group (VMBG)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Shih-Chin: lead

MeSH Terms

Conditions

Burnout, Professional; Occupational Stress; Parasomnias; Cognitive Dysfunction; Burnout, Psychological; Sleep Initiation and Maintenance Disorders

Interventions

Respiration

Condition Hierarchy (Ancestors)

Occupational Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Chia-Hui Lin, Ph.D.

  School of Nursing, National Defense Medical Center

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

+886918507906; ssking0918507906@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, School of Nursing, National Defense Medical Center

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 19, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2025-06