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NCT Number: NCT07470697

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

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.

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Key information

Conditions

Stress Behavior Behavioral Symptoms Burnout, Psychological Stress Biomarkers Stress and Burnout Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Perceived Stress level

    Time frame: - immediately before each intervention (pre-intervention) - immediately after each intervention (post-intervention)

    NRS score ranging from 0 (not stessed) to 10 (very stressed)

  2. 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)

    Non invasive biomarkers eg heart rate and heart rate variability measured with a polarOH1 armband

Secondary outcomes

  1. User satisfaction

    Time frame: Immediately after completion of the last intervention of the study (post intervention after the third intervention)

    NRS score ranging from 0 (not satisfied) to 10 (very satisfied)

  2. 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

    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)

Other outcomes

  1. Burnout

    Time frame: Baseline

    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.

  2. Burnout

    Time frame: Baseline

    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.

  3. Resilience

    Time frame: Baseline

    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.

  4. Resilience

    Time frame: Baseline

    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.

  5. Stress

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie Q Vermeulen, MD

CONTACT

[email protected]

0031639012875

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Rigshospitalet, Denmark
  • Universitätsklinikum Hamburg-Eppendorf

Registry information

Acronym: DEEP_VR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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