Personalized Stress Management With Application of Portable Devices in Occupational Populations

Stress, Psychological Clinical Trial

— PSMPD  

Official title:

Knowledge Translation of Personalized Stress Management in Occupational Populations With Application of HUAWEI Portable Devices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05239065
• Other study ID #: HWTJ2019085075
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: Huazhong University of Science and Technology
• Contact: Fengfei Ding, MD
• Phone: 13476255813
• Email: francesding2016[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Emotional Stress
• Nervous System Diseases
• Primary Dysautonomias
• Stress, Psychological

Intervention

Behavioral:
• The basic intervention
The participants will receive a paper-printed booklet introducing stress and stress management strategies, regular exercise, deep breathing and mediation, etc, as well as a HUAWEI portable device at the recruitment. During the following 3-month intervention phase, there is not informational materials, portable device data feedback, online group discussion or interpersonal communications with the participants. The participants will only need to fill in a simplified questionnaire biweekly.
• The personalized interventions
The participants will receive a paper-printed booklet introducing stress and stress management strategies and a HUAWEI portable device at the recruitment. A neurologist will be the health educator to host an online group for free communications. The typical stress-relieving methods and the strategies of using portable device will be explained by providing small videos, online article links and nursing coaching in person. The health educator will give regular knowledge educations about the stress hazards, stress management necessities and skills on weekly basis. The weekly data of HUAWEI portable devices will be sent to the participants along with personalized suggestions by trained nurses. At certain occasions, gifts and rewards will be sent out for encouragement and keeping attachment to the program. The participants will be required to fill in the weekly questionnaires online for feedback.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Wuhan No.1 Hospital

Country where clinical trial is conducted

China, 

References & Publications (20)

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* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the frequency of applications of stress-relieving strategies compared to the baseline	The frequency of applications of stress-relieving strategies, including daily physical activity, deep slow breathing activity, relaxation or mindfulness meditation, which would be conducted by the participants voluntarily, will be summarized on weekly basis.	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
Primary	Change of the Chinese version of Perceived Stress Scale (PSS score) for evaluation of stress compared to the baseline	Perceived Stress Scale (PSS score) assess the extent of feeling of nervousness and loss of control, including 14 questions. For each question, "1" for "Never", "2" for "Once in a while", "3" for "Sometimes", "4" for "Often", "5" for "Always". The total score is between 14-70.A higher score indicates a higher level of perceived stress.	Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Primary	Change of depression Anxiety Stress Scale (DASS score) for assessing stress, depression and anxiety compared to the baseline	The Depression Anxiety Stress Scale (DASS-12) has been demonstrated to be a reliable and valid measure in assessing mental health in the Chinese population. Questions 3, 5, 10, 13, 16, 17 and 21 formed the depression subscale. The total depression subscale score was divided into normal (0-9), mild depression (10-12), moderate depression (13-20), severe depression (21-27), and extremely severe depression (28-42). Questions 2, 4, 7, 9, 15, 19, and 20 formed the anxiety subscale. The total anxiety subscale score was divided into normal (0-6), mild anxiety (7-9), moderate anxiety (10-14), severe anxiety (15-19), and extremely severe anxiety (20-42). Questions 1, 6, 8, 11, 12, 14, and 18 formed the stress subscale. The total stress subscale score was divided into normal (0-10), mild stress (11-18), moderate stress (19-26), severe stress (27-34), and extremely severe stress (35-42).	Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Primary	Change of trier work-stress scale (TICS-9 scale) for evaluating the sources of chronic stress in daily life compared to the baseline	The Trier Inventory for Chronic Stress (TICS) is a standardized questionnaire for assessing nine interrelated factors of chronic stress from 9 dimensions: Work Overload, Social Overload, Pressure to Perform, Work Discontent, Excessive Demands from Work, Lack of Social Recognition, Social Tensions, Social Isolation, and Chronic Worrying. The TICS-9 is a short version of the original 57-item TICS. This version includes nine items reflecting all dimensions of the long version. The items can be rated from 0 to 5 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = very often). Higher values suggest greater stress. Satisfactory psychometrics have been evidenced in several studies, with Cronbach's Alpha ranging from a = 0.88-0.91.	Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Primary	Change of the Fatigue Scale (FAS) for evaluating fatigue compared to the baseline	The Fatigue Scale (FAS) was used to measure total fatigue, and includes 10 items rated on a 5-point rating scale (1=never~ 5=always). This scale has good reliability and content validity for measuring fatigue in a general or worker population.	Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Primary	Change of the Epworth Sleepiness Scale for sleep quality compared to the baseline	The Epworth Sleepiness Scale (ESS) includes 8 items and assesses the general level of daytime sleepiness. Scores range from 0-24 where higher scores indicate greater sleepiness. Following the developer's suggestion, a score greater than 10 was classified as high daytime sleepiness.	Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Primary	Change of the Subjective Happiness Scale (SHS) for evaluating subjective global happiness compared to the baseline	The Subjective Happiness Scale (SHS) is a four-item measure of subjective global happiness rated on a seven-point Likert scale. A single SHS score is the mean of the responses to the four items. SHS scores can range from 1 to 7, where a higher score indicates a higher level of happiness.	Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Primary	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	Heart rate variability (HRV) to assess the autonomic nervous system using different parameters from time-domain analysis (SDNN, SDNN index, SDANN index, RMMSD), the unit for these parameters are all "millisecond". The participants will have 24 hr cardiac holter monitoring at the recruitment and the last day of 3-month intervention.; SDNN: Standard deviation of NN intervals, NN interval is the time (normalized) between two detected heartbeat detections. (unit: ms) SDANN: Standard deviation of the average NN intervals for each 5 min segment of a 24 h HRV recording. (unit: ms) SDNN index: Mean of the standard deviations of all the NN intervals for each 5 min segment of a 24 h HRV recording. (unit: ms) RMMSD: Root mean square of successive RR interval differences. (unit: ms)	Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Primary	Change of heart rate variability (HRV) parameters (time-domain analysis: pNN50) for assessing the autonomic nervous system compared to the baseline	Heart rate variability (HRV) to assess the autonomic nervous system using different parameters from time-domain analysis (pNN50), the unit for these parameters are all "percentage %". The participants will have 24 hr cardiac holter monitoring at the recruitment and the last day of 3-month intervention.; pNN50: Percentage of successive RR intervals that differ by more than 50 ms. (unit: %)	Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Primary	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	Heart rate variability (HRV) to assess the autonomic nervous system using different parameters from frequency-domain analysis (VLF power, LF power, HF power), all the units are "ms2". The participants will have 24 hr cardiac holter monitoring at the recruitment and the last day of 3-month intervention.; VLF (very-low-frequency) power: Absolute power of the very-low-frequency band (0.0033-0.04 Hz) (unit: ms2).; LF (low-frequency) power: Absolute power of the low-frequency band (0.04-0.15 Hz)(unit: ms2).; HF (high-frequency) power: Absolute power of the high-frequency band (0.15-0.4 Hz) (unit: ms2).	Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Primary	Change of heart rate variability (HRV) parameters (frequency-domain analysis: LF/HF) for assessing the autonomic nervous system compared to the baseline	Heart rate variability (HRV) to assess the autonomic nervous system using different parameters from frequency-domain analysis (LF/HF), the unit is "percentage %". The participants will have 24 hr cardiac holter monitoring at the recruitment and the last day of 3-month intervention.; LF/HF: Ratio of LF(low-frequency)-to-HF(high-frequency) power.(unit: %).	Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Secondary	Change of the daily travel distance as evaluated by portable device compared to the baseline	The participants will be encouraged to wear HUAWEI bracelet on daily basis to monitor the amount of exercise. The daily travel distance recorded by the bracelet will be summarized to reveal the difference along with the time of interventions.	Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
Secondary	Change of medium-to-high level exercise time duration as evaluated by portable device compared to the baseline	The participants will be encouraged to wear HUAWEI bracelet on daily basis to monitor the amount of exercise. The time duration of conducting medium-to-high level exercise recorded by the bracelet will be summarized to reveal the difference along with the time of interventions.	Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
Secondary	Change of the total steps traveled daily as evaluated by portable device compared to the baseline	The participants will be encouraged to wear HUAWEI bracelet on daily basis to monitor the amount of exercise. The total steps traveled daily recorded by the bracelet will be summarized to reveal the difference along with the time of interventions.	Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
Secondary	Change of the daily duration for wearing portable device compared to the baseline	The participants will be encouraged to wear HUAWEI bracelet on daily basis. The daily duration for wearing HUAWEI bracelet will be summarized to reveal the difference along with the time of interventions to reflect the establishment of the habit of wearing portable device.	Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)