NCT07666633

Brief Summary

Newly graduated nurses often experience high levels of psychological stress, sleep disturbance, fatigue, and burnout during the early transition into clinical practice. Early identification of burnout and retention risk may help improve mental well-being, workforce stability, and quality of patient care. This longitudinal observational study aims to develop a non-invasive sleep-based prediction platform for assessing burnout and retention risk among postgraduate nurses. Participants will undergo repeated psychological assessments and non-contact sleep monitoring during the study period. Sleep-related physiological parameters, including sleep efficiency, sleep structure, heart rate variability, and respiratory variability, will be collected together with validated psychological questionnaires. The study will further apply machine learning and artificial intelligence approaches to integrate longitudinal physiological and psychological data for risk prediction and early identification of burnout-related conditions. The findings may support future development of precision mental health monitoring and supportive management strategies for high-stress healthcare workers.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Aug 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Aug 2026Apr 2027

First Submitted

Initial submission to the registry

May 18, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2027

Last Updated

June 24, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 18, 2026

Last Update Submit

June 18, 2026

Conditions

Keywords

Postgraduate NursesNon-Invasive Sleep MonitoringBurnout RiskRetention RiskArtificial IntelligenceMachine LearningSleep QualityHeart Rate VariabilityShift WorkPsychological Stress

Outcome Measures

Primary Outcomes (5)

  • Copenhagen Burnout Inventory (CBI) Score

    Assessment of burnout severity using the Copenhagen Burnout Inventory (CBI), a validated questionnaire for evaluating personal and work-related burnout symptoms. The CBI score ranges from 0 to 100, with higher scores indicating greater burnout severity.

    Baseline, 3 months, and 6 months

  • Pittsburgh Sleep Quality Index (PSQI) Score

    Assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire for evaluating subjective sleep quality and sleep disturbance. The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

    Baseline, 3 months, and 6 months

  • Brief Symptom Rating Scale-5 (BSRS-5) Score

    Assessment of psychological distress using the Brief Symptom Rating Scale-5 (BSRS-5), a validated questionnaire for evaluating anxiety, depression, hostility, interpersonal sensitivity, and insomnia symptoms. The BSRS-5 total score ranges from 0 to 20, with higher scores indicating greater psychological distress.

    Baseline, 3 months, and 6 months

  • Chinese Health Questionnaire-12 (CHQ-12) Score

    Assessment of mental health status using the Chinese Health Questionnaire-12 (CHQ-12), a validated questionnaire for evaluating psychological well-being and minor psychiatric morbidity. Higher scores indicate poorer mental health status.

    Baseline, 3 months, and 6 months

  • Karolinska Sleepiness Scale (KSS) Score

    Assessment of subjective sleepiness using the Karolinska Sleepiness Scale (KSS). The KSS score ranges from 1 to 9, with higher scores indicating greater subjective sleepiness.

    Baseline, 3 months, and 6 months

Secondary Outcomes (4)

  • Sleep Efficiency

    Baseline, 3 months, and 6 months

  • Deep Sleep Proportion

    Baseline, 3 months, and 6 months

  • REM Sleep Stability

    Baseline, 3 months, and 6 months

  • Heart Rate Variability

    Baseline, 3 months, and 6 months

Study Arms (1)

Postgraduate Nurses (PGNs)

Newly employed postgraduate nurses within the first three months of clinical practice will be enrolled and followed longitudinally. Participants will complete repeated psychological assessments and undergo non-invasive sleep monitoring during the study period. Sleep-related physiological parameters, including sleep efficiency, sleep structure, heart rate variability, and respiratory variability, will be analyzed to evaluate burnout risk, psychological stress, fatigue, and retention risk during the early clinical transition period.

Diagnostic Test: Non-Invasive Sleep Monitoring

Interventions

Participants will undergo non-invasive and non-contact sleep monitoring under natural sleep conditions. The monitoring system will collect sleep-related physiological signals and estimate sleep parameters, including sleep efficiency, sleep stage distribution, deep sleep proportion, REM sleep stability, heart rate variability, and respiratory variability. This procedure is used for observational data collection only and does not involve treatment or changes to clinical work schedules.

Postgraduate Nurses (PGNs)

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of newly employed postgraduate nurses during the early clinical transition period at a medical center in Taiwan. Participants will be followed longitudinally to evaluate sleep-related physiological characteristics, psychological stress, burnout risk, and retention risk using repeated questionnaires and non-invasive sleep monitoring.

You may qualify if:

  • Newly employed postgraduate nurses within the first 3 months of clinical practice
  • Age 20 to 65 years
  • Full-time clinical nursing staff
  • Able to read and complete Chinese questionnaires
  • Willing to participate in repeated psychological assessments and non-invasive sleep monitoring
  • Able to provide written informed consent

You may not qualify if:

  • Diagnosed severe sleep disorders
  • Diagnosed severe psychiatric disorders
  • Current use of medications that significantly affect sleep or autonomic nervous system function
  • Inability to comply with longitudinal follow-up procedures
  • Inability to complete repeated sleep monitoring assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Armed Forces General Hospital

Kaohsiung City, Kaohsiung City, 80284, Taiwan

Location

MeSH Terms

Conditions

Burnout, PsychologicalParasomniasOccupational StressPsychological Well-BeingFatigueSleep Initiation and Maintenance DisordersStress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Wake DisordersNervous System DiseasesMental DisordersOccupational DiseasesPersonal SatisfactionSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomnias

Study Officials

  • Yung-Kuo Lee, PhD

    Kaohsiung Armed Forces General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yung-Kuo Lee, PhD

CONTACT

Chih-Hsuan Chang, MS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

June 24, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

April 23, 2027

Study Completion (Estimated)

April 23, 2027

Last Updated

June 24, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

No individual participant data (IPD) will be shared because the study involves sensitive psychological and physiological data collected from healthcare workers, and data sharing is restricted to protect participant privacy and confidentiality in accordance with institutional research ethics regulations.

Locations