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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Устройство 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
• Поведенческое 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

Первичные конечные точки

• Generalized Anxiety Disorder Scale (GAD-7) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Measured once after viewing the educational video and prior to entering the operating room.]
• Intraoperative Visual Analogue Scale for Anxiety (VAS-A intra) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Measured once postoperatively, after the patient has left the operating room and is in the pre-recovery area.]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07214116 · SICEIA-2025-1206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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