Effect of Virtual Reality and Trans Auricular X-Vagus Nerve Stimulation for Anxiety and Depressio… (NCT07198737) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Virtual Reality and Trans Auricular X-Vagus Nerve Stimulation for Anxiety and Depression in Chronic Shoulder Pain Patients
United Kingdom10 participantsStarted 2025-11-01
Plain-language summary
Chronic shoulder pain is a debilitating condition that significantly impacts quality of life, daily functioning, and mental well-being. For individuals awaiting surgical intervention for a long period, prolonged pain often leads to heightened psychological distress, poor sleep quality, and reduced overall health outcomes. Innovative approaches are urgently needed to address these challenges and improve preoperative management.
This study will combine 2 technologies which have both been shown to help relax and calm users.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is
* a gentle non-invasive therapy that uses a small device to send tiny electrical pulses to a spot on your outer ear. The principle of using electrical pulses are similar to pacemaker or TENS machines.
* These pulses help stimulate a special nerve called the vagus nerve, which is like a superhighway between your brain and your body
Your vagus nerve helps control:
* Your mood and anxiety levels
* Healing of nerves and other organs in the body
* How your body handles pain
* Digestion, heart rate, and more By stimulating the vagus nerve, taVNS can help your body relax, reset, and feel better.
While virtual reality (VR) has demonstrated effectiveness in distracting from pain and improving psychological resilience.
These two will be combined so that the participant experiences a relaxing VR environment that helps them control their breathing while receiving taVNS. With the aim of managing chronic pain by targeting both physical and psychological dimensions.
This study aims to evaluate the feasibility and safety, of a trial of taVNS paired with VR looking at trial recruitment, retention and compliance. Secondary to this the study will look to see if there is evidence of taVNS +VR in reducing pain, enhancing psychological well-being, and improving quality of life for individuals with chronic shoulder pain awaiting surgery. It will provide critical insights into the potential of this combined intervention as a preoperative and potentially post operative pain management strategy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged over 18.
* Ability to understand English
* Ability to provide informed consent and attend in-person sessions
* Chronic shoulder pain (pain lasting for at least 6 months) waiting on surgical pathway.
* Comorbid mild-to-moderate anxiety or depression
* Referred by a consultant orthopaedic surgeon.
* Unresponsive to conventional treatment for 6 months including antidepressants, physiotherapy, and/ or oral analgesics
* Mean NRS pain score ≥ 5 on most or all days either continuously or in motion
Exclusion Criteria:● Inability to understand English and consent process
* History of significant neurological or psychiatric conditions unrelated to chronic pain (e.g., epilepsy, psychosis, schizophrenia).
* Skin lesions or piercing or extensive tattooing of the concha or Skin disease: infection, eczema or cancer of the ears or skin in region where VR headset or taVNS would sit
* Presence of active implants (e.g. cochlear implant, implanted vagus nerve stimulator, cardiac pacemaker, implantable cardioverter defibrillator (ICD) deep brain stimulations or spinal cord stimulators, ventriculoperitoneal (VP) shunt).
* Inability to tolerate VR (e.g., severe motion sickness, vertigo or balance issues, claustrophobia).
* Fear of heights
* Active infections, significant trauma, or other acute conditions affecting the shoulder.
* Pregnancy and women trying actively to conceive
* Pre-existing Persistent post-surgical pain-(\>6 months) from surgeries other than shoulder …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment and retention rates
Timeframe: from enrolment to the end of treatment at 5 weeks
Trial details
NCT IDNCT07198737
SponsorEast Kent Hospitals University NHS Foundation Trust