RecruitingNAINTERVENTIONAL

Evaluation of the Impact of Virtual Reality on Sedation Use in Patients Undergoing Regional Anesthesia for Scheduled Orthopedic Surgery

The VIRTUALR study is exploring a new way to help people feel more relaxed during orthopaedic surgery. If you're having an operation on an arm or leg and will be awake with a regional anaesthetic (meaning only part of your body is numb), this study might be for you. Researchers are comparing two groups: one uses a virtual reality headset with relaxation techniques, and the other receives standard care. The main goal is to see if virtual reality helps lower anxiety and makes patients happier with their experience. They'll ask you to fill out questionnaires to understand how you felt during and after the surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Eure-Seine

Enrolment target

164

Start

18 Jul 2024

Estimated completion

19 Jul 2025

Orthopedic Procedure Anesthesia Sedation

What is this study about?

Imagine you're having surgery on your arm or leg, and the doctors have numbed just that part of your body so you're awake but don't feel pain. Even though you won't feel the operation, it’s normal to feel a bit anxious or nervous. This study, called VIRTUALR, is looking into a comforting new approach to help patients feel more at ease during this time.

Researchers want to see if using a virtual reality (VR) headset during your surgery can help distract you and reduce any worries. The VR headset would show you calming scenes or guided relaxation exercises, almost like a mini-holiday for your mind. They believe this might make the experience more pleasant than simply receiving standard care, which usually involves speaking to the medical team and perhaps having some music playing.

By comparing a group of patients using VR to a group receiving standard care, the study aims to understand if this technology really makes a difference. They'll ask patients about their anxiety levels and how satisfied they were with their experience to see if VR is a good way to improve patient comfort during surgery. It's all about making your time in the operating room as calm and positive as possible.

Key takeaways

The study uses virtual reality (VR) to help patients relax during surgery.
It's for scheduled orthopaedic operations on arms or legs, using regional anaesthesia.
Patients either use VR with relaxation techniques or receive standard care.
The main goal is to reduce anxiety and improve patient satisfaction.
Participation involves questionnaires around your surgery time, with no extra visits.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older, and planning to have an orthopaedic operation on an arm or leg where you'll be awake but the area will be numb from regional anaesthetic. You also need to be able to give your clear agreement to take part and be covered by a social security system, like the NHS.

There are some reasons why you might not be able to join. For example, if you're having emergency surgery, or if you already have certain mental health conditions, communication difficulties, or can't understand the study information. Also, if you need medication to relax before you even get to the operating room, or if the VR equipment would interfere with your surgery, you wouldn't be able to participate. Your care team can help you understand if this study is suitable for you.

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.

Are you 18 years old or older?
Are you having a planned orthopaedic operation on your arm or leg?
Will you be awake during your surgery with regional anaesthesia (numbed body part)?
Can you understand the study information and give your consent?
Do you not have certain serious mental health conditions or communication problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your participation would happen on the day of your surgery. You'd be randomly placed into one of two groups: either you'd use a virtual reality headset during your surgery with some simple relaxation suggestions, or you'd receive the usual care without the headset. You wouldn't know which group you're in until shortly before your surgery.

Throughout the study, you'll be asked to fill out some questionnaires. These will help the researchers understand if you felt anxious during the surgery and how satisfied you were with your experience afterwards. There are no extra hospital visits or long-term follow-up appointments involved; everything happens around the time of your surgery.

Potential risks and benefits

Taking part might help you feel more relaxed and less anxious during your surgery, potentially making your experience more positive. You'd also be helping doctors understand better ways to comfort patients in the future. There are very few risks expected with using a VR headset for a short time; some people might feel a little dizzy or have mild eye strain, but this is uncommon. Remember, you can change your mind and leave the study at any time, for any reason, and this won't affect your medical care.

Locations (1)

Centre Hospitalier Eure-Seine
Verified postcode
Évreux, France· Recruiting

Common questions

What is 'regional anaesthesia'?

Regional anaesthesia means only a specific part of your body is numbed for surgery, so you stay awake during the operation but won't feel any pain in the treated area.

Will I have to pay to use the VR headset?

No, if you're in the group using the VR headset, it will be provided to you for free as part of the study.

What kind of surgery is this study for?

This study is for planned (scheduled) orthopaedic surgeries of the arm or leg where you'll have regional anaesthesia.

What if I don't like the virtual reality experience?

You can stop using the VR headset at any time if you feel uncomfortable or don't like it. Your comfort is important.

How will my feelings be measured?

You'll be asked to fill out some simple questionnaires about your anxiety levels and how satisfied you feel, both during and after your surgery.

How to find out more

Lydia BEN BEKKOU

arc2.circe@ch-eureseine.fr 02 32 33 86 75 Official trial record

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