Virtual Reality, Music, and Education to Reduce Anxiety in Patients Undergoing Ingrown Toenail Surgery

Summary

The main objective of this clinical trial is to evaluate whether watching an educational video before surgery, combined with the use of virtual reality or music during surgery, can reduce anxiety and pain in people undergoing ingrown toenail (onychocryptosis) surgery.

The main questions the study aims to answer are:

Are the educational video, virtual reality, and music effective in controlling and reducing pain and anxiety during surgery compared to traditional surgery?

As a distraction technique, is virtual reality or music more effective in reducing pain and anxiety during surgery?

Do these interventions produce changes in patients' physiological parameters during surgery?

Is there a relationship between patients' sociodemographic characteristics and their level of anxiety when undergoing surgery?

Three study groups will be compared to determine the effect of each intervention:

Experimental Group 1: watch a 5-minute educational video before entering the operating room and use virtual reality glasses with a 360° immersive video of a relaxing walk in the forest during surgery.

Experimental Group 2: watch the 5-minute educational video before surgery and listen to carefully selected instrumental music through noise-canceling headphones during surgery.

Control Group: surgery performed in the traditional way, without an educational video, virtual reality, or music.

All participants will complete questionnaires to assess anxiety, pain, and satisfaction before and after surgery.

Conditions

• Ingrown Toenail

Interventions

BEHAVIORAL

Educational Video

The educational video will last 5 minutes and is designed to inform participants about the onychocryptosis surgical procedure. The principal investigator will clearly and accessibly explain what the surgery involves, the steps to follow, and what participants can expect before, during, and after the procedure.

DEVICE

Virtual Reality

Participants will use Meta Quest 3 VR glasses during the onychocryptosis surgery. The device features adjustable straps, interpupillary distance settings, and built-in headphones with spatial sound, allowing immersive visualization and audio tailored to patient preferences. Disposable masks will be used for hygiene. The immersive content will be a 360-degree video of a relaxing walk through a forest accompanied by gentle music, starting 5 minutes before the procedure. Patients may remove the glasses or stop the VR experience at any time if desired.

BEHAVIORAL

Music Therapy

Participants will wear over-ear headphones with disposable covers and noise-cancellation (Bose® QuietComfort 25) connected to an Apple® iPod. Music will start 5 minutes before the ingrown toenail surgery and continue throughout the procedure. Only instrumental classical music, royalty-free and from Musopen.org, will be played in a 1-hour playlist. The same playlist will be used for all participants. Participants can adjust the volume at any time. Music will be temporarily paused if communication with the patient is needed and resumed afterward.

Sponsors & Collaborators

• University of Seville

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-31

Primary Completion

2027-01-31

Completion

2027-01-31