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ClinicalTrials.gov ID

NCT07470697

Lead Sponsor

Amsterdam UMC, location VUmcOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

80Estimated

Last Update Posted

Mar 13, 2026Actual

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Jul 1, 2026Estimated

Completion Date

Jul 1, 2026Estimated

Official Title

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

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.

• Stress
• Stress and Burnout
• Stress Biomarkers

• Virtual Reality intervention
• Low Stimulus Environment

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

Single

Lead Sponsor

Amsterdam UMC, location VUmcOTHER

Collaborators

Universitätsklinikum Hamburg-EppendorfOTHER

Rigshospitalet, DenmarkOTHER

f.nickel@uke.de+49 40 74100