Effect of Virtual Reality and Trans Auricular X-Vagus Nerve Stimulation for Anxiety and Depression in Chronic Shoulder Pain Patients
If you have ongoing shoulder pain and are waiting for surgery, this study might be for you. It's testing a new approach that combines two calming techniques: virtual reality (VR) and transcutaneous auricular vagus nerve stimulation (taVNS). VR helps distract from pain and makes you feel more relaxed, while taVNS uses gentle electrical pulses on your ear to stimulate a special nerve that helps control mood, pain, and how your body reacts to stress. The study wants to see if this combination can reduce your pain, improve your mood, and help you feel better overall while you wait for your operation. It will also check if the treatment is safe and easy for people to use.
At a glance
What is this study about?
Living with ongoing shoulder pain can be really tough, affecting your daily life, sleep, and even your mood. If you're waiting a long time for surgery, this can make feelings of anxiety and depression even worse. Doctors are always looking for better ways to help people in this situation feel more comfortable and improve their well-being before an operation. That's where this study comes in.
This study is exploring a new way to help by combining two calming methods. One is called Transcutaneous Auricular Vagus Nerve Stimulation (taVNS). It's a gentle, non-invasive treatment where a small device sends tiny electrical pulses to a specific spot on your outer ear. Think of it a bit like a TENS machine, but it targets a special nerve called the vagus nerve. This nerve is like a main road connecting your brain to many parts of your body. It plays a big role in controlling your mood, how your body handles pain, and your stress levels, helping you to relax and feel better. The other method is virtual reality (VR). VR has already shown promise in helping people feel distracted from pain and improve their ability to cope with difficult situations. The idea is that the VR will create a relaxing environment and guide your breathing, while the taVNS works to calm your nervous system.
The main goals of this study are to make sure this combined approach is safe and that people can easily take part. It will also look at whether this combination of VR and taVNS can help reduce your pain, lift your mood, and improve your overall quality of life while you're waiting for shoulder surgery. By understanding more about this treatment, the researchers hope to offer new ways to manage pain and well-being, not just before surgery, but possibly afterwards too.
Key takeaways
- This study combines virtual reality (VR) and nerve stimulation (taVNS) for ongoing shoulder pain.
- It aims to reduce pain, anxiety, and depression in people waiting for surgery.
- taVNS uses gentle electrical pulses on the ear to calm the vagus nerve.
- VR helps with distraction from pain and promotes relaxation.
- The study assesses safety and how well people can use the combined treatment.
- Potential benefits include improved well-being before your operation.
Who may be eligible?
This study is looking for adults aged 18 and over who have been living with ongoing shoulder pain for at least six months and are currently waiting for shoulder surgery. You should also be able to understand English and attend study visits in person. Importantly, the study is for people who also experience mild to moderate anxiety or depression alongside their pain, and whose pain hasn't improved with usual treatments like physiotherapy or painkillers for the past six months.
There are also some reasons why you might not be able to join. For example, if you have certain medical conditions like epilepsy, severe motion sickness from VR, or if you have an implanted device like a pacemaker or a cochlear implant. Skin conditions on your ears or where the VR headset sits might also prevent you from taking part. If you are pregnant or trying to get pregnant, or if you have widespread pain conditions like fibromyalgia, this study won't be suitable for you.
- Are you 18 years old or older?
- Have you had chronic shoulder pain for at least 6 months and are waiting for surgery?
- Do you also experience mild to moderate anxiety or depression?
- Has your pain not improved with standard treatments for 6 months?
- Do you not have a pacemaker or similar implanted device?
- Are you comfortable trying virtual reality without severe motion sickness?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you'll be trying out a combination of virtual reality (VR) and transcutaneous auricular vagus nerve stimulation (taVNS). The study doesn't involve any new medications. You'll have regular appointments where you'll use the VR headset and the taVNS device. During these sessions, you might be asked to fill out questionnaires or talk about your pain levels, mood, and how you're feeling. The researchers will be checking things like how often you use the equipment and what you think of it. The total duration of your involvement will be explained to you, including any follow-up appointments after the main treatment period. You'll receive full details about what to expect at each stage and how many visits are involved.
Potential risks and benefits
Locations (1)
- East kent Clinical trials UnitMargate, United Kingdom
Common questions
What is the vagus nerve?
It's a really important nerve that connects your brain to many parts of your body, helping to control your mood, how you feel pain, and your stress levels.
How does taVNS work?
A small device sends gentle electrical pulses to a specific spot on your outer ear, which then stimulates your vagus nerve to help you relax and feel better.
Will the VR make me feel sick?
Some people can experience motion sickness with VR, and if you're prone to it or have severe vertigo, this study might not be suitable for you. This will be checked carefully.
Will I have to stop my current pain treatments?
You'll need to discuss this with the study team. Some treatments might need to be paused during the study, but not usually antidepressants unless there's a specific reason.
What happens if I decide I don't want to continue?
You are free to leave the study at any time, for any reason, without it affecting your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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