Clinical trial NCT05239065: Personalized Stress Management With Application of Portable Devices in Occupational Populations
Official title: Knowledge Translation of Personalized Stress Management in Occupational Populations With Application of HUAWEI Portable Devices
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress, Psychological
Autonomic Nervous System Diseases
Emotional Stress
Keywords: Stress at work
Stress management
Autonomic system
Physical exercise
Relaxation
Knowledge translation
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Wuhan No.1 Hospital
First posted: 2022-02-14
Enrollment: 400
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Hospital setting is a stressful environment to the hospital staff due to work shifts, high level of responsibility, stressful challenging situations, as well as work and emotional pressures. The rate of burnout among hospital staff is high, as well as the risk of depression and suicide. The association between chronic work stress in hospital and the development of metabolic syndrome, cardiovascular complications and cancer is well established. However, it is actually not easy for the hospital staff to establish a healthier life habit and stress management skills by themselves due to the busy work schedule and the lack of persistence of building up new habits. We hypothesized that conduction of the personalized stress management coaching with the assistance of portable device could be beneficial for the hospital staff to adopt a few healthy behaviors for daily practice, which could reduce stress and the related consequences. The current study will be conducted in two separate hospitals from Wuhan (China) with different intervention strategies and conduction teams. Each institution will recruit 200 participants and complete the full set of biographic information collections at recruitment. Clinical score evaluations, biosample collections as well as 24 h Holter monitoring will be both collected at the recruitment and after 3-month intervention phase. Tongji hospital will receive the active stress-management intervention; the health educator will group the participants together and provide on a weekly basis: stress knowledge and stress-related hazards online, stress management necessities and skills. Meanwhile, weekly data of exercises, cardiac health and sleep condition generated from HUAWEI portable devices will be summarized and sent to the participants together with personalized suggestions and encouragement by trained nurses. Participants from Tongji hospital will be involved in a social network to share their experience and gain insight from the discussions. Finally, they will also complete an electronic diary that covers elements of daily life and stress management activity. The Control institution will be Wuhan No1 hospital, the participants will receive minimum information regarding stress and stress management; they will not receive personalized intervention and will not be involved in group chat. They will be asked to fill in a simplified questionnaire biweekly. The outcome parameters will be the stress relief evaluated by clinical forms and questionnaires, heart rate variability (HRV) parameters, and the establishments of healthier life habits. The current study design would propose a novel strategic stress management plan for the hospital administrates in order to improve the hospital staff health.


Eligibility criteria: Inclusion Criteria:

* Working as night-shift staff in Tongji hospital
* Need to keep this position for at least 6 months (no plan to leave)
* Selection will ensure a good balance of age and gender
* Willing to participate in the study and sign the consent form

Exclusion Criteria:

* Planning to leave the hospital or the units for any reason
* Not a good medical condition or context for reliable follow-up
* Having a serious medical condition (for instance cancer, stroke)
* Living in a special life context that is source of stress

Primary outcomes:
measure: Change of the frequency of applications of stress-relieving strategies compared to the baseline
timeFrame: Baseline (The first week of participating the program) , endpoint time point (The last week of participating the program), and every week between these 2 time points during the 3-month intervention
measure: Change of the Chinese version of Perceived Stress Scale (PSS score) for evaluation of stress compared to the baseline
timeFrame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
measure: Change of depression Anxiety Stress Scale (DASS score) for assessing stress, depression and anxiety compared to the baseline
timeFrame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
measure: Change of trier work-stress scale (TICS-9 scale) for evaluating the sources of chronic stress in daily life compared to the baseline
timeFrame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
measure: Change of the Fatigue Scale (FAS) for evaluating fatigue compared to the baseline
timeFrame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
measure: Change of the Epworth Sleepiness Scale for sleep quality compared to the baseline
timeFrame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
measure: Change of the Subjective Happiness Scale (SHS) for evaluating subjective global happiness compared to the baseline
timeFrame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
measure: Change of heart rate variability (HRV) parameters (time-domain analysis:SDNN, SDNN index, SDANN index, RMMSD) for assessing the autonomic nervous system compared to the baseline
timeFrame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
measure: Change of heart rate variability (HRV) parameters (time-domain analysis: pNN50) for assessing the autonomic nervous system compared to the baseline
timeFrame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
measure: Change of heart rate variability (HRV) parameters (frequency-domain analysis: VLF power, LF power, HF power) for assessing the autonomic nervous system compared to the baseline
timeFrame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
measure: Change of heart rate variability (HRV) parameters (frequency-domain analysis: LF/HF) for assessing the autonomic nervous system compared to the baseline
timeFrame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Secondary outcomes:
measure: Change of the daily travel distance as evaluated by portable device compared to the baseline
timeFrame: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
measure: Change of medium-to-high level exercise time duration as evaluated by portable device compared to the baseline
timeFrame: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
measure: Change of the total steps traveled daily as evaluated by portable device compared to the baseline
timeFrame: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
measure: Change of the daily duration for wearing portable device compared to the baseline
timeFrame: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
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