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

Official title

Effectiveness of Educational Intervention, Virtual Reality, and Music Therapy on Anxiety in Onychocryptosis Surgery

Overview

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.

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 gla
• 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

Primary outcome measures

• Generalized Anxiety Disorder Scale (GAD-7) [Time frame: The scale will be completed by patients after viewing the educational video and before entering the operating room.]
• The Amsterdam Preoperative Anxiety and Information Scale (APAIS) [Time frame: The scale will be completed by patients after viewing the educational video and before entering the operating room.]
• Preoperative Visual Analogue Scale for Anxiety (VAS-A pre) [Time frame: Measured once after viewing the educational video and prior to entering the operating room.]
• Intraoperative Visual Analogue Scale for Anxiety (VAS-A intra) [Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.]
• Postoperative Visual Analogue Scale for Anxiety (VAS-A post) [Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.]
• State-Trait Anxiety Inventory - State-Anxiety Subscale (STAI-S) [Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.]
• Visual Analogue Scale for Maximum Pain (VAS-P Max) [Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.]
• Visual Analogue Scale for Average Pain (VAS-P average) [Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.]

Secondary outcome measures (12)

• Preoperative Systolic Blood Pressure [Time frame: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.]
• Preoperative Diastolic Blood Pressure [Time frame: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.]
• Preoperative Heart Rate [Time frame: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.]
• Preoperative Oxygen Saturation [Time frame: Measured once prior to the start of surgery, after 5 minutes of rest while the patient is seated.]
• Intraoperative Systolic Blood Pressure [Time frame: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.]
• Intraoperative Diastolic Blood Pressure [Time frame: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.]
• Intraoperative Heart Rate [Time frame: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.]
• Intraoperative Oxygen Saturation [Time frame: Measured at four specific intraoperative moments: disinfection, anesthesia administration, first incision, and bandaging.]
• Postoperative Systolic Blood Pressure [Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.]
• Postoperative Diastolic Blood Pressure [Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.]
• Postoperative Heart Rate [Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.]
• Postoperative Oxygen Saturation [Time frame: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.]

Eligibility criteria

Inclusion criteria

• Adults aged 18 years or older of any sex.
• Diagnosed with ingrown toenail (onychocryptosis) requiring surgical treatment.
• Cognitive ability to understand study information, follow instructions, and complete questionnaires.

Exclusion criteria

• Patients requiring ingrown toenail surgery associated with another pathology or surgical technique (e.g., subungual exostosis, chondroma, foreign bodies, tenotomies, etc.).
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07214116 · SICEIA-2025-1206

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗