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| Name | Class |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| Rigshospitalet, Denmark | OTHER |
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The goal of this clinical trials is to primary learn if deep relaxation using Virtual Reality (VR) compared to a low stimulus environment can lower perceived and measured stress in healthcare professionals working in the operating room.
We aim to determine:
Hypothesis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAB | Experimental | VR - VR - low stimulus environment |
|
| ABA | Experimental | VR - low stimulus environment - VR |
|
| BAA | Experimental | Low stimulus environment - VR - VR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality intervention | Device | Participants will receive a VR headset, in which the participant can choose from a number of VR images and sceneries of the HealthyMind® (HM) VR simulation to relax. The software is able to adapt to user's HR and HRV, and developed by Partner HealthyMind (HM). HRV is chosen as prime parameter for biofeedback steering of scenery, as it is highly indicative and considered reliable in measuring a person's stress level. (27-30) Before starting the experience, participants select a VR scenery based on their personal preference. Allowing participants to choose their own VR scenery minimizes the risk of exposing them to an environment that could be stress-inducing rather than stress-reducing.(31, 32) HR and HRV will be measured in real time during the intervention using the POLAR OH1 armband built and registered for the purpose. We chose the POLAR OH1 band because of its accurate HRV measurements, its ability to connect with the VR device, and its user-friendliness. In respo |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress level | NRS score ranging from 0 (not stessed) to 10 (very stressed) | - immediately before each intervention (pre-intervention) - immediately after each intervention (post-intervention) |
| Non invasive biomarkers | Non invasive biomarkers eg heart rate and heart rate variability measured with a polarOH1 armband | immediately before each intervention (pre-intervention) for 5 minutes, during the intervention 10 minutes and immediately after each intervention 1 minute (post-intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| User satisfaction | NRS score ranging from 0 (not satisfied) to 10 (very satisfied) | Immediately after completion of the last intervention of the study (post intervention after the third intervention) |
| Cost-effectiveness analysis (CEA) of the intervention. up to 50 weeks after the last participant has completed all interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Burnout | The Burnout Assessment Tool (BAT-12) is a brief 12-item self-report instrument that measures participant's four core burnout symptoms. Items are rated on a five-point Likert scale ranging from 1 (Never) to 5 (Always). Higher scores indicate the participant's frequency of these symptoms. | Baseline |
| Burnout |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Q Vermeulen, MD | Contact | 0031639012875 | s.q.vermeulen@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marlies p Schijven, Prof. dr. | AmsterdamUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhigshospitalet | Copenhagen | Denmark |
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|
| Low Stimulus Environment | Other | Participants will be brought into an induced low-sensory, low-stimulus environment. This entails wearing the VR headset with a dark-only display, and no sound on headphones. This, to facilitate a calm environment without distractions. Before the start of the intervention, the VR headset will display a short visual and audio message confirming that the participant is in a low-stimulus environment and that the system is functioning properly. |
|
Cost-effectiveness will be assessed using a health economic evaluation framework. Direct and indirect costs of the intervention (e.g. staff time, training costs, materials, healthcare utilization) will be collected and compared against measured outcomes (e.g., reduction in stress/burnout and measured biomarkers) |
| through study completion, an average of 1 year |
Maslach Burnout inventory (MBI) is a validated self-report questionnaire that measures burnout across three dimensions. Items are rated on a seven-point Likert scale ranging from 0 (Never) to 6 (Every day). Higher scores on Emotional Exhaustion and Depersonalization, and lower scores on Personal Accomplishment, indicate higher levels of burnout. |
| Baseline |
| Resilience | The 8-item Resilience Survey for Healthcare Professionals is a brief self-report instrument designed to assess resilience among healthcare workers. Items are rated on a five-point Likert scale ranging from 1 (Strongly disagree) to 5 (Strongly agree). Higher scores indicate greater resilience. | Baseline |
| Resilience | The Connor-Davidson Resilience Scale (CD-RISC) is a validated self-report questionnaire. The scale contains 25 items rated on a five-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). Higher total scores indicate greater resilience. | Baseline |
| Stress | The Perceived Stress Scale (PSS) is a self-report questionnaire. Items are rated on a five-point Likert scale ranging from 0 (Never) to 4 (Very often). Higher scores indicate higher levels of perceived stress. | Baseline |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany |
|
| ID | Term |
|---|---|
| D000077062 | Burnout, Psychological |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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