Clinical research announcement: The University of Seville is set to initiate a groundbreaking study examining how virtual reality (VR), educational videos, and music therapy can alleviate anxiety for patients undergoing minor ingrown toenail surgery. Though the study is not yet recruiting, its potential to transform perioperative care models is drawing interest from clinical and regulatory teams worldwide.
What are the study details?
The clinical trial is spearheaded by the University of Seville and focuses exclusively on patients diagnosed with ingrown toenails, a common condition requiring minor surgical intervention. The study will use a combination of non-invasive interventions that include virtual reality devices, music therapy sessions, and an educational video delivered pre-surgery. These strategies aim to reduce preoperative anxiety levels while supporting an overall better patient experience. While recruitment has not yet commenced, the trial could set new standards for the integrated use of behavioral and technological therapies in clinical environments.
Why does this matter?
Perceived stress and anxiety can significantly impact both outcomes and satisfaction rates in minor surgeries. Ingrown toenail procedures, though typically short, can cause notable discomfort for afraid or anxious patients. By combining virtual reality and music therapy with targeted educational tools, investigators hope to create a safer, more reassuring preoperative environment. If successful, this approach could reduce reliance on sedatives and physical restraints in minor procedures, shifting clinical protocols in favor of non-pharmacological techniques.
How will the interventions work?
Virtual Reality
Patients will interact with VR devices to immerse themselves in calming virtual environments tailored specifically for surgical preparation. The goal is relaxation and distraction from procedure-related anxiety triggers.
Music Therapy
Curated playlists featuring soothing melodies will be offered to patients as part of their perioperative experience. Music therapy has long shown promise in reducing cortisol levels and improving heart rate variability during stressful times.
Educational Videos
The educational video will outline the surgical process, address common worries, and emphasize the effectiveness and safety of the intervention. By offering knowledge upfront, patients may experience reduced uncertainty.
Frequently Asked Questions
1. When will the study begin recruiting? Recruitment status is currently “Not Yet Recruiting.” Updates can be tracked on the official clinical trial listing.
2. Who is eligible for participation? The trial targets individuals diagnosed with ingrown toenails slated for surgical removal.
3. Are the interventions FDA-cleared? Virtual reality devices and music therapy tools are not categorized as invasive medical devices and are being implemented as behavioral interventions.
4. Could these techniques be applied to other minor surgeries? While the focus is on ingrown toenail procedures, similar techniques could benefit other outpatient surgical settings depending on trial outcomes.
Key Takeaways
This upcoming clinical trial funded by the University of Seville emphasizes modern, non-invasive tools to address surgical anxiety. Combining patient-centered approaches like virtual reality, music therapy, and educational content could demonstrate new efficiencies in perioperative care while prioritizing safety and effectiveness. Stakeholders in medical technology should watch for further developments.
Disclaimer
This content is informational only and does not constitute legal or medical advice. Consult regulatory or legal experts for professional guidance.
Announcement Source
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07214116?term=medical+device