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ID
Source
Brief title
Health condition
Burn-out
Sponsors and support
Intervention
Outcome measures
Primary outcome
As the primary outcome data has a multilevel structure (multiple VAS session scores within participants), VAS scores are analyzed with mixed model multilevel regression analyses (MIXED command), including factor time (length of baseline and before vs. after session). Models have a random intercept for participant. The estimation method is set to restricted maximum likelihood and the covariance structure to unstructured. The immediate effects of VRelax is analyzed by comparing mean VAS scores between multiple baseline and intervention periods, and before and after sessions. Covariates include sociodemographic characteristics and baseline level of stress, symptoms and functioning.
Secondary outcome
Mean scores on the questionnaires will be compared between baseline and end of treatment, using repeated measures ANOVA. Use of medication and substances will be compared between baseline and end of treatment with repeated measures ANOVA. Other parameters used as covariates in analyses of primary and secondary outcomes.
Background summary
Rationale: Work-related stress is highly prevalent among workers in the Netherlands. Stress is a key factor in development and unfavourable course of burn-out problems. Societal costs as a result of work production loss are € 2.8 billion for work-related stress. Mental and occupational healthcare resources are lacking to meet all treatment demands. Effective and easy self-management stress reduction interventions are urgently needed to increase well-being and reduce mental health problems of workers. Virtual Reality (VR) relaxation may provide a solution.
Objective: Primary Objective: to evaluate the immediate and short-term effect of a self-management immersive VR relaxation application on perceived stress and burn-out problems in workers presenting to occupational health services with work-related stress. Secondary Objective(s): to explore level of functioning, work absenteeism and work engagement before and after use of VR relaxation.
Study design: Non concurrent multiple baseline (randomized to 3, 6 or 9 days baseline measures) intervention study.
Study population: Employees of companies affiliated with insurance company Zilveren Kruis, who present with psychosocial stress and burn-out symptoms at occupational health services.
Intervention: Daily 20-minute use of self-management VR relaxation tool at home during three weeks.
Main study parameters/endpoints: the immediate effect on level of psychological stress, measured with two Visual Analogue Scales (VAS; range 0-100) once daily during 3, 6 or 9 days before start of the VRelax intervention, and before and after each VRelax session: “I feel relaxed” and “I feel calm”. Secondary outcomes include level of perceived stress, burn-out symptoms, functioning, work engagement and absenteeism.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants are randomized to 3, 6 or 9 days baseline measure of once daily two VAS items (2 minutes). They will fill in a digital questionnaire before and after the intervention period (20 minutes each). They complete two VAS items before and after each of the daily 20-minute VR relaxation sessions during three weeks. Risks are negligible; some people will experience mild and transient discomfort (nausea, dizziness) caused by the VR Head Mounted Display. Expected benefits include immediate relaxation, reduction of perceived stress and burn-out symptoms and improved functioning. As there is no control group, all participants will receive the VR relaxation intervention.
Study objective
Expected benefits include immediate relaxation, reduction of perceived stress and burn-out symptoms and improved functioning.
Study design
1. A potential participant is informed about the study by the occupational healthcare service he/she attends. It should be noted that the use of VRelax is regular practice; the study only concerns the evaluation of VRelax in the companies’ occupational healthcare setting.
2. If the potential participants agrees, the occupational health service worker sends his/her contact details to the VRelax study team by email.
3. Additional information will be provided by a return email, including the document ‘proefpersoneninformatie’ and informed consent form.
4. If a person decides to participate, he/she signs the informed consent form digitally. This process cannot be done in person, given the anticipated large number of companies and participants across the entire country.
5. Next, the participant will receive the baseline digital questionnaire. After completion he/she is randomized to 3, 6 or 9 days baseline VAS item measures.
6. During the baseline days, participants receive links to the VAS items via sms on their smartphone. After completing the last day of VAS items, a user code is automatically sent, by which VRelax can be activated. VAS items will continue during intervention and 6 days after intervention.
6. The participant has received a HMD with the VRelax application from the occupational health services he/she attends. He/she is instructed to use VRelax (at least) once daily for 20 minutes. Before and after each session, two VAS items are completed within the VRelax application. Scores are automatically uploaded to the study database.
7. After three weeks, the participant returns the HMD to the occupational health service. The VRelax study team sends a link to the follow-up digital questionnaire by email to the participant. After three and ten days, a reminder email is sent to the participant if the questionnaire has not been completed.
Intervention
Daily 20-minute use of self-management VR relaxation tool at home during three weeks.
Inclusion criteria
- >18 years of age.
- Parttime or fulltime employed.
- At least moderate level of self-reported psychosocial stress.
- At least mild burn-out symptoms, judgement of occupational health service worker.
Exclusion criteria
- IQ <70.
- Poor vision.
- Actual epilepsy (convulsion during past 12 months).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL9316 |
CCMO | NL74671.042.20 |