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

Overview

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.

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 o
• 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.

Primary outcome measures

• Perceived Stress level [Time frame: - immediately before each intervention (pre-intervention) - immediately after each intervention (post-intervention)]
• Non invasive biomarkers [Time frame: immediately before each intervention (pre-intervention) for 5 minutes, during the intervention 10 minutes and immediately after each intervention 1 minute (post-intervention)]

Secondary outcome measures (2)

• User satisfaction [Time frame: 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 [Time frame: through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

• Volunteering and consented healthcare professionals ( ≥ 18 years) working in the operating room
• Circulatory-, scrub-, and anesthesia nurses, anesthesiologists, surgical specialists, residents, medical students, or persons in training for the above mentioned.

Exclusion criteria

• history of epilepsy.
• claustrophobia or nyctophobia.
• experienced VR scenery via a headset including headphones a trigger for headache, migraine, dizziness, drowsiness, nausea or other physical or mental discomfort.
• vestibular nystagmus, otosclerosis, ear infections,
• impaired hearing or deafness of either ear.
• glaucoma, active eye infections or damage to orbital, cornea or lens.
• diagnosed with chronic insomnia .
• latex allergy as VR goggles may contain latex in the lens surround.
• arrythmia, bradycardia or tachycardia, or those using cardiac medication against dysrhythmias.
• All medication that may potentially induce dysrhythmias or of influence on blood pressure levels.
• not able to wear a VR headset and/or noise canceling headphones for any other reason as indicated by themselves.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Denmark · 1 center

• Rhigshospitalet — Copenhagen

Germany · 1 center

• University Medical Center Hamburg-Eppendorf — Hamburg

Identifiers

NCT: NCT07470697 · Horizon-HLTH-2023-CARE-04-02-B

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗