StressDEEP_VRNCT07470697
Deep Relaxation Using Virtual Reality Intervention Before Surgery for Healthcare Professionals Working in the Operating Room
A study testing Virtual Reality intervention and Low Stimulus Environment in people with Stress and Stress and Burnout, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Stress and Burnout, Stress Biomarkers
- What is being tested?
- Virtual Reality intervention and Low Stimulus Environment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Denmark1 site
Rhigshospitalet
Copenhagen
Jeanett Strandbygaard, MD, PhD, +45 35 45 35 45, jeanett.strandbygaard@regionh.dk
Germany1 site
University Medical Center Hamburg-Eppendorf
Hamburg
Felix Nickel, +49 40 74100, f.nickel@uke.de
About this study
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:
Read more
- 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
- Being tested
- Virtual Reality intervention, Low Stimulus Environment
- 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
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality interventionDevice
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 EnvironmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AAB | Experimental | VR - VR - low stimulus environment Receives: Device: Virtual Reality intervention; Other: Low Stimulus Environment |
| ABA | Experimental | VR - low stimulus environment - VR Receives: Device: Virtual Reality intervention; Other: Low Stimulus Environment |
| BAA | Experimental | Low stimulus environment - VR - VR Receives: Device: Virtual Reality intervention; Other: Low Stimulus Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress level
NRS score ranging from 0 (not stessed) to 10 (very stressed)
Measured: - 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
Measured: 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
NRS score ranging from 0 (not satisfied) to 10 (very satisfied)
Measured: 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
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)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Marlies P. Schijven, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marlies p Schijven, Prof. dr., Principal investigator, AmsterdamUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470697
- Sponsor's protocol ID
- Horizon-HLTH-2023-CARE-04-02-B
- Acronym
- DEEP_VR
- Status last verified
- Sep 2026
- First submitted
- 19 Aug 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Relaxation Using Virtual Reality Intervention Before Surgery for Healthcare Professionals Working in the Operating Room
- ClinicalTrials.gov ID
- NCT07470697
- Acronym / sponsor ID
- DEEP_VR / Horizon-HLTH-2023-CARE-04-02-B
- Conditions
- Stress, Stress and Burnout, Stress Biomarkers
- Keywords
- VR, Virtual Reality, Stress, Non-invasice biomarkers, Heart rate variabillity, Heart rate, Burnout, Resilience
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Universitätsklinikum Hamburg-Eppendorf, Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AAB | Experimental | Device: Virtual Reality intervention, Other: Low Stimulus EnvironmentVR - VR - low stimulus environment |
| ABA | Experimental | Device: Virtual Reality intervention, Other: Low Stimulus EnvironmentVR - low stimulus environment - VR |
| BAA | Experimental | Device: Virtual Reality intervention, Other: Low Stimulus EnvironmentLow stimulus environment - VR - VR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality interventionParticipants 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 | Device | AAB, ABA, BAA |
| Low Stimulus EnvironmentParticipants 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. | Other | AAB, ABA, BAA |
Primary outcome
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)
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marlies p Schijven, Prof. dr. principal investigator
AmsterdamUMC
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality intervention and Low Stimulus Environment in people with Stress and Stress and Burnout, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Q Vermeulen, MD (0031639012875, s.q.vermeulen@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress level (time frame: - immediately before each intervention (pre-intervention) - immediately after each intervention (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.