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

NCT07470697 | Not Yet Recruiting

• 1 other identifier: Horizon-HLTH-2023-CARE-04-02-B
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Stress; Stress and Burnout; Stress Biomarkers

Keywords

VR; Virtual Reality; Stress; Non-invasice biomarkers; Heart rate variabillity; Heart rate; Burnout; Resilience; hospital; operating room; healthcare professionals; doctor; operating room nurse; anesthesia nurse; surgeon; low stimulus environment

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (2)

• User satisfaction

  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

  through study completion, an average of 1 year

Other Outcomes (5)

• Burnout

  Baseline

• Burnout

  Baseline

• Resilience

  Baseline

Study Arms (3)

AAB

EXPERIMENTAL

VR - VR - low stimulus environment

Device: Virtual Reality intervention; Other: Low Stimulus Environment

ABA

EXPERIMENTAL

VR - low stimulus environment - VR

Device: Virtual Reality intervention; Other: Low Stimulus Environment

BAA

EXPERIMENTAL

Low stimulus environment - VR - VR

Device: Virtual Reality intervention; Other: Low Stimulus Environment

Interventions

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

AAB; ABA; BAA

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.

AAB; ABA; BAA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (2)

Rhigshospitalet

Copenhagen, Denmark

Location

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Marlies p Schijven, Prof. dr.

  AmsterdamUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Q Vermeulen, MD

CONTACT

0031639012875; s.q.vermeulen@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, drs.

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: March 13, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-02

Locations

DK (1); DE (1)