CClinicalTrials.gg
Not yet recruitingNCT07470697DEEP_VRUpdated Sep 3, 2026

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

An interventional study of Virtual Reality intervention and Low Stimulus Environment in Stress, Stress and Burnout and Stress Biomarkers, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    AAB

    VR - VR - low stimulus environment

    Device: Virtual Reality intervention · Other: Low Stimulus Environment

  • Experimental
    ABA

    VR - low stimulus environment - VR

    Device: Virtual Reality intervention · Other: Low Stimulus Environment

  • Experimental
    BAA

    Low stimulus environment - VR - VR

    Device: Virtual Reality intervention · Other: Low Stimulus Environment

Interventions

  • DeviceVirtual 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

  • OtherLow 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.

05

What researchers measure

Primary outcomes

  1. Perceived Stress level

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

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

  2. Non invasive biomarkers

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

    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 outcomes

  1. User satisfaction

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

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

  2. Cost-effectiveness analysis (CEA) of the intervention. up to 50 weeks after the last participant has completed all interventions

    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)

    Time frame: through study completion, an average of 1 year

Other outcomes

  1. 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.

    Time frame: Baseline

  2. Burnout

    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.

    Time frame: Baseline

  3. 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.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

06

Study locations

2 sites
  • Rhigshospitalet
    Copenhagen, Denmark
  • University Medical Center Hamburg-Eppendorf
    Hamburg, Germany
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07470697
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Universitätsklinikum Hamburg-Eppendorf, Rigshospitalet, Denmark
Responsible party
Marlies P. Schijven (Prof. dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
Mar 13, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Sep 3, 2026

Study contacts

Sophie Q Vermeulen, MD
Contact
s.q.vermeulen@amsterdamumc.nl
0031639012875
Marlies p Schijven, Prof. dr.
principal investigator · AmsterdamUMC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion