Patient Research
Sign in
All studies
RecruitingNAINTERVENTIONAL

Virtual Reality in Awake Surgery : Pilot Study VIRAS

This study, called VIRAS, is investigating whether virtual reality (VR) headsets can be comfortably used during operations where patients need to be awake. Operations like some brain surgeries for tumours or epilepsy often require patients to be conscious so doctors can check their brain function in real-time. Remaining awake can be stressful, so the study wants to see if VR headsets can help reduce anxiety and make the experience better for patients. Initially, the VR equipment was tested on patients having simpler bone surgeries under local anaesthetic to make sure it was safe and well-tolerated. Now, the study will test the same VR setup on patients having awake brain surgery. This next step will also include special software within the VR system to help doctors perform brain function tests tailored to each patient during the operation.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital, Brest
Enrolment target
50
Start
24 May 2022
Estimated completion
01 Aug 2027
Surgery

What is this study about?

Imagine needing an important brain operation, but staying awake during part of it so doctors can make sure they don't harm important brain functions like speech or movement. This can sound quite daunting, and it's understandable that patients might feel anxious or uncomfortable. This research project, called VIRAS, is looking into a clever way to make this experience better: by using virtual reality (VR) headsets.

The main goal of VIRAS is to see if these VR headsets are not only safe and well-tolerated by patients but also if they can help reduce stress and discomfort during these awake surgeries. The idea is that by focusing on an immersive VR experience, patients might feel less anxious and more relaxed while the surgery is happening. Doctors also hope that using VR can help with monitoring brain activity in a supportive way during the operation.

The study is happening in two stages. First, the VR equipment was tested on patients having bone operations under local anaesthetic, which are less complex than brain surgery. This careful first step helped to confirm that the VR headsets were comfortable and that patients tolerated them well. Now, the study is moving on to test the same VR equipment with patients undergoing awake brain surgery. This second stage will also involve special computer programs within the VR system that help doctors carry out specific tests of brain function tailored to each patient during their operation.

Key takeaways

  • This study explores using VR to reduce anxiety during awake surgery.
  • It aims to make awake brain surgery more comfortable for patients.
  • The VR equipment was already tested for safety in other surgeries.
  • Special software in the VR will help doctors monitor brain function during surgery.
  • Patients aged 18-75 might be eligible, depending on their surgery type and health.
  • Participation involves wearing a VR mask and having your comfort monitored.

Who may be eligible?

This study is looking for adults aged between 18 and 75 years old. To take part, you must be well enough for the surgery you are undergoing and be able to give your full consent. For the initial part of the study, you would need to be having an orthopedic (bone) surgery under local anaesthetic that is expected to last at least one hour.

If you are being considered for the second part of the study, you would need to be scheduled for awake brain surgery. This decision is usually made by a team of specialists after several careful checks, including psychological and neurological assessments.

You would not be able to join the study if you have certain existing conditions, such as known brain disorders, significant memory problems, or a history of vertigo (dizziness). If you suffer from claustrophobia, have vision problems that would make a VR mask difficult to use, or if your doctor advises against it for any reason, you wouldn't be able to participate. Also, if you are an outpatient or unable to give your consent, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you between 18 and 75 years old?
  2. Are you scheduled for orthopedic surgery under local anaesthetic or awake brain surgery?
  3. Do you have any known severe brain conditions or memory issues?
  4. Do you suffer from severe vertigo or claustrophobia?
  5. Do you have good enough vision to use a VR mask comfortably?
  6. Are you able to give your full consent to participate?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a training session to get used to the virtual reality (VR) mask before your surgery. During your surgery, you will wear the VR mask, and the study team will be monitoring the device and how you are feeling, including any anxiety you might experience. They will also assess how acceptable and comfortable you find wearing the VR mask throughout the procedure. There are no specific medications involved in the study research itself beyond what you would normally receive for your surgery, and the follow-up will mainly focus on your experience with the VR device during and shortly after the surgery. The total duration of your participation in the study would be mainly focused around your surgical procedure and the immediate recovery period.

Potential risks and benefits

Participating in this study might offer the potential benefit of a more comfortable and less anxious experience during your surgery, thanks to the distraction provided by virtual reality. However, there's always a chance you might find the VR mask uncomfortable, or the VR experience itself might not be to your liking, potentially causing some mild feelings of claustrophobia or dizziness. The researchers have carefully tested the equipment to minimise these risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Pr SEIZEUR Romuald
    Verified postcode
    Brest, France· Recruiting

Common questions

What is 'awake surgery'?

Awake surgery means you are conscious during part of your operation, often so doctors can check your brain functions like movement or speech in real-time.

What is Virtual Reality (VR)?

VR uses a special headset to create an immersive, artificial environment that you can see and interact with, making you feel like you are somewhere else.

Why is VR being used in surgery?

Doctors hope VR can distract patients during awake surgery, making them less anxious and more comfortable during the procedure.

Will I wear the VR mask for the whole operation?

The study will assess how well the VR mask is tolerated and its acceptability, so you might wear it for a significant part of the awake portion of your surgery.

What if I feel uncomfortable with the VR mask?

The study staff will be monitoring you closely. If you feel uncomfortable, you can communicate this, and the VR mask can be adjusted or removed.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Virtual Reality in Awake Surgery : Pilot Study VIRAS…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.