Personalized Stress Management With Application of Portable Devices in Occupational Populations

NCT ID: NCT05239065

Last Updated: 2022-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stress, Psychological Autonomic Nervous System Diseases Emotional Stress

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Personalized stress management nursing coaching with application of portable device

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.

Group Type EXPERIMENTAL

The personalized interventions

Intervention Type BEHAVIORAL

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.

Minimum information transfer and assistance of building up healthy life habits

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.

Group Type SHAM_COMPARATOR

The basic intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wuhan No.1 Hospital

OTHER

Sponsor Role collaborator

Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Wei Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tongji Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fengfei Ding, MD

Role: CONTACT

13476255813

Facility Contacts

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Fengfei Ding, MD

Role: primary

13476255813

References

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Reference Type RESULT
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Wang Q, Collet JP, Mei J, Chen G, Huang S, Yang Y, Wang W, Ding F. Complex interactive multimodal intervention to improve personalized stress management among healthcare workers in China: A knowledge translation protocol. Digit Health. 2023 Jul 24;9:20552076231184052. doi: 10.1177/20552076231184052. eCollection 2023 Jan-Dec.

Reference Type DERIVED
PMID: 37545629 (View on PubMed)

Other Identifiers

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HWTJ2019085075

Identifier Type: -

Identifier Source: org_study_id

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