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Effect of Virtual Reality and Trans Auricular X-Vagus Nerve Stimulation for Anxiety and Depression in Chronic Shoulder Pain Patients

NCT07198737 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-30

No results posted yet for this study

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.

Conditions

  • Chronic Pain (Back / Neck)

Interventions

DEVICE

VR and VNS

Participants will have Vagus nerve stimulation at the same time as a relaxing VR experience

Sponsors & Collaborators

  • East Kent Hospitals University NHS Foundation Trust

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-07-01
Completion
2026-08-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07198737 on ClinicalTrials.gov