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NOT YET RECRUITING
NCT07470697
NA

Deep Relaxation Using Virtual Reality Intervention Before Surgery for Healthcare Professionals Working in the Operating Room

Sponsor: Amsterdam UMC, location VUmc

View on ClinicalTrials.gov

Summary

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: * whether the use of a low-stimulus environment significantly lowers the stress response in OR health care workers just before entering the OR; * whether the use of a responsive VR system environment significantly lowers the stress response in OR health care workers just before entering the OR; * Whether the use of a responsive VR environment is both an effective and cost-effective solution compared to the low-stimulus environment, in terms of significantly mitigating stress in OR team members as measured by their biometrics, just before they enter the OR to do their job. Hypothesis * The use of a 10-minute real-time adaptive VR intervention or a low-stimulus environment intervention administered at least 15 minutes before entering the operating room (OR), significantly reduces stress in OR staff, as measured by a within-person reduction in heart rate of at least 10 beats per minute (BPM) over the 10-minute intervention period * The reduction in heart rate over a 10-minute intervention period is significantly greater for the real-time adaptive VR intervention compared to the low-stimulus environment intervention, with an expected mean difference (delta) of 5 BPM, indicating superior stress-reducing effects of the VR intervention. * The use of a real-time adaptive VR intervention and the use of a low stimulus environment intervention of 10 minutes at least 15 minutes before entering the OR significantly reduces perceived stress for OR staff, as measured by Numeric Rating Scale (NRS) stress scores within person.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-06-01

Completion Date

2026-07-01

Last Updated

2026-03-13

Healthy Volunteers

Yes

Interventions

DEVICE

Virtual Reality intervention

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

OTHER

Low Stimulus Environment

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.

Locations (2)

Rhigshospitalet

Copenhagen, Denmark

University Medical Center Hamburg-Eppendorf

Hamburg, Germany