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临床试验/NCT07470697
NCT07470697尚未招募不适用

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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
2
主要终点
Perceived Stress level

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

BAA

Experimental

Low stimulus environment - VR - VR

干预措施: Low Stimulus Environment (Other)

AAB

Experimental

VR - VR - low stimulus environment

干预措施: Virtual Reality intervention (Device)

AAB

Experimental

VR - VR - low stimulus environment

干预措施: Low Stimulus Environment (Other)

ABA

Experimental

VR - low stimulus environment - VR

干预措施: Virtual Reality intervention (Device)

ABA

Experimental

VR - low stimulus environment - VR

干预措施: Low Stimulus Environment (Other)

BAA

Experimental

Low stimulus environment - VR - VR

干预措施: Virtual Reality intervention (Device)

结局指标

主要结局

Perceived Stress level

时间窗: - 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

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marlies P. Schijven

Prof. dr.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (2)

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