Stress, PsychologicalPSMPDNCT05239065
Personalized Stress Management With Application of Portable Devices in Occupational Populations
A study testing The basic intervention and The personalized interventions in people with Stress, Psychological and Autonomic Nervous System Diseases, run by Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Autonomic Nervous System Diseases, Emotional Stress
- What is being tested?
- The basic intervention and The personalized interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430000
Fengfei Ding, MD, 13476255813, francesding2016@163.com
About this study
Official title: Knowledge Translation of Personalized Stress Management in Occupational Populations With Application of HUAWEI Portable Devices
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.
- Being tested
- The basic intervention, The personalized interventions
- Keywords
- Stress at work, Stress management, Autonomic system, Physical exercise, Relaxation, Knowledge translation
- Medical subject headings
- Stress, Psychological, Autonomic Nervous System Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The basic interventionBehavioural
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 interventionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized stress management nursing coaching with application of portable device | Experimental | Arm (Tongji Hospital) All the participants will receive a paper-printed brochure introducing stress and stress management strategies and the instruction of using HUAWEI portable device at the recruitment. During the 3-month intervention phase, multiple formats of stress and stress management knowledge educations will be sent by the health educator on weekly basis. The participants will have personalized stress management nursing coaching and assistance of building up new life habits, they will be also encouraged to submit a weekly questionnaire for self-evaluation. Finally, participants from Tongji hospital will be involved in a social network to share their experience anonymously and gain knowledge from the group chat. Receives: Behavioral: The personalized interventions |
| Minimum information transfer and assistance of building up healthy life habits | Sham comparator | Arm2 (Wuhan No1 Hospital) - The participants will only receive a paper-printed brochure introducing stress and stress management strategies and the instruction of using HUAWEI portable device at the recruitment. There is no recurrent knowledge education, interpersonal communications, data feedbacks with the participants during the 3-month intervention phase. Receives: Behavioral: The basic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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).
Measured: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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 α = 0.88-0.91.
Measured: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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.
Measured: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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.
Measured: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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.
Measured: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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)
Measured: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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: %)
Measured: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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).
Measured: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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: %).
Measured: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
Secondary outcomes (4)
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.
Measured: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
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.
Measured: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
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.
Measured: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
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.
Measured: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start1 Oct 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan No.1 Hospital
- Responsible party
- Principal investigator, Wei Wang, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239065
- Sponsor's protocol ID
- HWTJ2019085075
- Acronym
- PSMPD
- Status last verified
- Feb 2022
- First submitted
- 13 Dec 2021
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dziembowska I, Izdebski P, Rasmus A, Brudny J, Grzelczak M, Cysewski P. Effects of Heart Rate Variability Biofeedback on EEG Alpha Asymmetry and Anxiety Symptoms in Male Athletes: A Pilot Study. Appl Psychophysiol Biofeedback. 2016 Jun;41(2):141-50. doi: 10.1007/s10484-015-9319-4.
PubMed 26459346Scherz WD, Seepold R, Madrid NM, Crippa P, Ortega JA. RR interval analysis for the distinction between stress, physical activity and no activity using a portable ECG. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:4522-4526. doi: 10.1109/EMBC44109.2020.9175458.
PubMed 33018999Harvey SB, Epstein RM, Glozier N, Petrie K, Strudwick J, Gayed A, Dean K, Henderson M. Mental illness and suicide among physicians. Lancet. 2021 Sep 4;398(10303):920-930. doi: 10.1016/S0140-6736(21)01596-8.
PubMed 34481571Marchalik D. Physician burnout in the modern era. Lancet. 2019 Mar 2;393(10174):868-869. doi: 10.1016/S0140-6736(19)30399-X. No abstract available.
PubMed 30837137West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28.
PubMed 27692469Debnath S, Levy TJ, Bellehsen M, Schwartz RM, Barnaby DP, Zanos S, Volpe BT, Zanos TP. A method to quantify autonomic nervous system function in healthy, able-bodied individuals. Bioelectron Med. 2021 Aug 27;7(1):13. doi: 10.1186/s42234-021-00075-7.
PubMed 34446089Hamasaki H. Effects of Diaphragmatic Breathing on Health: A Narrative Review. Medicines (Basel). 2020 Oct 15;7(10):65. doi: 10.3390/medicines7100065.
PubMed 33076360De Couck M, Caers R, Musch L, Fliegauf J, Giangreco A, Gidron Y. How breathing can help you make better decisions: Two studies on the effects of breathing patterns on heart rate variability and decision-making in business cases. Int J Psychophysiol. 2019 May;139:1-9. doi: 10.1016/j.ijpsycho.2019.02.011. Epub 2019 Mar 1.
PubMed 30826382Davila MI, Lewis GF, Porges SW. The PhysioCam: A Novel Non-Contact Sensor to Measure Heart Rate Variability in Clinical and Field Applications. Front Public Health. 2017 Nov 22;5:300. doi: 10.3389/fpubh.2017.00300. eCollection 2017.
PubMed 29214150Bonaz B, Sinniger V, Pellissier S. Vagal tone: effects on sensitivity, motility, and inflammation. Neurogastroenterol Motil. 2016 Apr;28(4):455-62. doi: 10.1111/nmo.12817.
PubMed 27010234Prinsloo GE, Derman WE, Lambert MI, Laurie Rauch HG. The effect of a single session of short duration biofeedback-induced deep breathing on measures of heart rate variability during laboratory-induced cognitive stress: a pilot study. Appl Psychophysiol Biofeedback. 2013 Jun;38(2):81-90. doi: 10.1007/s10484-013-9210-0.
PubMed 23435801Aguilar-Raab C, Stoffel M, Hernandez C, Rahn S, Moessner M, Steinhilber B, Ditzen B. Effects of a mindfulness-based intervention on mindfulness, stress, salivary alpha-amylase and cortisol in everyday life. Psychophysiology. 2021 Dec;58(12):e13937. doi: 10.1111/psyp.13937. Epub 2021 Sep 15.
PubMed 34525214Watford TS, O'Brien WH, Koerten HR, Bogusch LM, Moeller MT, Sonia Singh R, Sims TE. The mindful attention and awareness scale is associated with lower levels of high-frequency heart rate variability in a laboratory context. Psychophysiology. 2020 Mar;57(3):e13506. doi: 10.1111/psyp.13506. Epub 2019 Nov 17.
PubMed 31737916Chin MS, Kales SN. Understanding mind-body disciplines: A pilot study of paced breathing and dynamic muscle contraction on autonomic nervous system reactivity. Stress Health. 2019 Oct;35(4):542-548. doi: 10.1002/smi.2887. Epub 2019 Sep 5.
PubMed 31347763Reive C. The Biological Measurements of Mindfulness-based Stress Reduction: A Systematic Review. Explore (NY). 2019 Jul-Aug;15(4):295-307. doi: 10.1016/j.explore.2019.01.001. Epub 2019 Jan 18.
PubMed 30765300
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge Translation of Personalized Stress Management in Occupational Populations With Application of HUAWEI Portable Devices
- ClinicalTrials.gov ID
- NCT05239065
- Acronym / sponsor ID
- PSMPD / HWTJ2019085075
- Keywords
- Stress at work, Stress management, Autonomic system, Physical exercise, Relaxation, Knowledge translation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Wuhan No.1 Hospital
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized stress management nursing coaching with application of portable device | Experimental | Behavioral: The personalized interventionsArm (Tongji Hospital) All the participants will receive a paper-printed brochure introducing stress and stress management strategies and the instruction of using HUAWEI portable device at the recruitment. During the 3-month intervention phase, multiple formats of stress and stress management knowledge educations will be sent by the health educator on weekly basis. The participants will have personalized stress management nursing coaching and assistance of building up new life habits, they will be also encouraged to submit a weekly questionnaire for self-evaluation. Finally, participants from Tongji hospital will be involved in a social network to share their experience anonymously and gain knowledge from the group chat. |
| Minimum information transfer and assistance of building up healthy life habits | Sham comparator | Behavioral: The basic interventionArm2 (Wuhan No1 Hospital) - The participants will only receive a paper-printed brochure introducing stress and stress management strategies and the instruction of using HUAWEI portable device at the recruitment. There is no recurrent knowledge education, interpersonal communications, data feedbacks with the participants during the 3-month intervention phase. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The basic interventionThe 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. | Behavioural | Minimum information transfer and assistance of building up healthy life habits |
| The personalized interventionsThe 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. | Behavioural | Personalized stress management nursing coaching with application of portable device |
Primary outcome
Change of the frequency of applications of stress-relieving strategies compared to the baseline
Time frame: 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
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.
Change of the Chinese version of Perceived Stress Scale (PSS score) for evaluation of stress compared to the baseline
Time frame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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.
Change of depression Anxiety Stress Scale (DASS score) for assessing stress, depression and anxiety compared to the baseline
Time frame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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).
Change of trier work-stress scale (TICS-9 scale) for evaluating the sources of chronic stress in daily life compared to the baseline
Time frame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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 α = 0.88-0.91.
Change of the Fatigue Scale (FAS) for evaluating fatigue compared to the baseline
Time frame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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.
Change of the Epworth Sleepiness Scale for sleep quality compared to the baseline
Time frame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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.
Change of the Subjective Happiness Scale (SHS) for evaluating subjective global happiness compared to the baseline
Time frame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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.
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
Time frame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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)
Change of heart rate variability (HRV) parameters (time-domain analysis: pNN50) for assessing the autonomic nervous system compared to the baseline
Time frame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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: %)
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
Time frame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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).
Change of heart rate variability (HRV) parameters (frequency-domain analysis: LF/HF) for assessing the autonomic nervous system compared to the baseline
Time frame: Baseline (at recruitment) and endpoint (the last day of 3-month intervention)
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: %).
4 secondary outcomes
Change of the daily travel distance as evaluated by portable device compared to the baseline
Time frame: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
Change of medium-to-high level exercise time duration as evaluated by portable device compared to the baseline
Time frame: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
Change of the total steps traveled daily as evaluated by portable device compared to the baseline
Time frame: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
Change of the daily duration for wearing portable device compared to the baseline
Time frame: Daily during the 3-month intervention (during the time of wearing the HUAWEI bracelet)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
- Background: PubMed 26459346Dziembowska I, Izdebski P, Rasmus A, Brudny J, Grzelczak M, Cysewski P. Effects of Heart Rate Variability Biofeedback on EEG Alpha Asymmetry and Anxiety Symptoms in Male Athletes: A Pilot Study. Appl Psychophysiol Biofeedback. 2016 Jun;41(2):141-50. doi: 10.1007/s10484-015-9319-4.
- Background: PubMed 33018999Scherz WD, Seepold R, Madrid NM, Crippa P, Ortega JA. RR interval analysis for the distinction between stress, physical activity and no activity using a portable ECG. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:4522-4526. doi: 10.1109/EMBC44109.2020.9175458.
- Results publication: PubMed 34481571Harvey SB, Epstein RM, Glozier N, Petrie K, Strudwick J, Gayed A, Dean K, Henderson M. Mental illness and suicide among physicians. Lancet. 2021 Sep 4;398(10303):920-930. doi: 10.1016/S0140-6736(21)01596-8.
- Results publication: PubMed 30837137Marchalik D. Physician burnout in the modern era. Lancet. 2019 Mar 2;393(10174):868-869. doi: 10.1016/S0140-6736(19)30399-X. No abstract available.
- Results publication: PubMed 27692469West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28.
- Results publication: PubMed 34446089Debnath S, Levy TJ, Bellehsen M, Schwartz RM, Barnaby DP, Zanos S, Volpe BT, Zanos TP. A method to quantify autonomic nervous system function in healthy, able-bodied individuals. Bioelectron Med. 2021 Aug 27;7(1):13. doi: 10.1186/s42234-021-00075-7.
- Results publication: PubMed 33076360Hamasaki H. Effects of Diaphragmatic Breathing on Health: A Narrative Review. Medicines (Basel). 2020 Oct 15;7(10):65. doi: 10.3390/medicines7100065.
- Results publication: PubMed 30826382De Couck M, Caers R, Musch L, Fliegauf J, Giangreco A, Gidron Y. How breathing can help you make better decisions: Two studies on the effects of breathing patterns on heart rate variability and decision-making in business cases. Int J Psychophysiol. 2019 May;139:1-9. doi: 10.1016/j.ijpsycho.2019.02.011. Epub 2019 Mar 1.
- Results publication: PubMed 29214150Davila MI, Lewis GF, Porges SW. The PhysioCam: A Novel Non-Contact Sensor to Measure Heart Rate Variability in Clinical and Field Applications. Front Public Health. 2017 Nov 22;5:300. doi: 10.3389/fpubh.2017.00300. eCollection 2017.
- Results publication: PubMed 27010234Bonaz B, Sinniger V, Pellissier S. Vagal tone: effects on sensitivity, motility, and inflammation. Neurogastroenterol Motil. 2016 Apr;28(4):455-62. doi: 10.1111/nmo.12817.
- Results publication: PubMed 23435801Prinsloo GE, Derman WE, Lambert MI, Laurie Rauch HG. The effect of a single session of short duration biofeedback-induced deep breathing on measures of heart rate variability during laboratory-induced cognitive stress: a pilot study. Appl Psychophysiol Biofeedback. 2013 Jun;38(2):81-90. doi: 10.1007/s10484-013-9210-0.
- Results publication: PubMed 34525214Aguilar-Raab C, Stoffel M, Hernandez C, Rahn S, Moessner M, Steinhilber B, Ditzen B. Effects of a mindfulness-based intervention on mindfulness, stress, salivary alpha-amylase and cortisol in everyday life. Psychophysiology. 2021 Dec;58(12):e13937. doi: 10.1111/psyp.13937. Epub 2021 Sep 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The basic intervention and The personalized interventions in people with Stress, Psychological and Autonomic Nervous System Diseases, run by Huazhong University of Science and Technology at 1 site in China.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fengfei Ding, MD (13476255813, francesding2016@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the frequency of applications of stress-relieving strategies compared to the baseline (time frame: 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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05239065, which also lists 22 linked publications.
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 14 Feb 2022.