Virtual Reality, Music, and Education to Reduce Anxiety in Patients Undergoing Ingrown Toenail Surgery
NCT ID: NCT07214116
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
175 participants
INTERVENTIONAL
2025-10-31
2027-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Control group
Participants undergo traditional onychocryptosis surgery without educational video, music, or virtual reality.
No interventions assigned to this group
Experimental group 1
Participants watch an educational video before the surgery and use virtual reality glasses during the onychocryptosis surgery.
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.
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.
Experimental group 2
Participants watch an educational video before the surgery and listen to music through headphones during the onychocryptosis surgery.
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with ingrown toenail (onychocryptosis) requiring surgical treatment.
* Cognitive ability to understand study information, follow instructions, and complete questionnaires.
Exclusion Criteria
* Patients with difficulties understanding Spanish.
* Patients with visual or auditory disabilities preventing full use of the educational video, virtual reality, or headphones.
* Patients with a diagnosis of trait anxiety, depression, or any emotional disorder.
* Patients under psychiatric treatment.
* Patients with chronic foot pain.
* Patients receiving treatment for chronic pain.
* Patients with epilepsy.
* Patients with severe vertigo.
* Patients with current facial injuries or burns.
* Patients under treatment for blood pressure.
* Patients with coagulation disorders.
* Patients with active infections.
* Pregnant women.
18 Years
ALL
No
Sponsors
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University of Seville
OTHER
Responsible Party
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Raquel Prieto Domínguez
University Degree in Podiatry
Other Identifiers
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SICEIA-2025-1206
Identifier Type: -
Identifier Source: org_study_id
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