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Набор скоро начнётся NCT07707726

Virtual Reality in Ingrown Toenail Surgery

Без фазы С лечением Ingrown Toenail Virtual Reality

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Virtual Reality (VR).
Кому может быть актуально
Состояния в реестре: Ingrown Toenail, Virtual Reality. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Effect of Virtual Reality Headset Use on Pain and Anxiety in Patients Undergoing Ingrown Toenail Surgery

Обзор

Ingrown toenail is a common condition that may cause significant pain, functional impairment, and recurrent disease. Although conservative management is appropriate for mild cases, moderate-to-severe or recurrent ingrown toenails are commonly treated surgically under local anesthesia. However, pain associated with the digital nerve block and procedure-related anxiety may negatively affect the patient experience. Virtual reality (VR) has emerged as a promising non-pharmacological intervention for reducing pain and anxiety during a variety of medical procedures by providing an immersive distraction. Nevertheless, evidence regarding its use during ingrown toenail surgery remains limited. The primary objective of this study is to evaluate the effect of VR on procedure-related pain intensity and anxiety in adults undergoing outpatient ingrown toenail surgery under local anesthesia compared with standard care. Secondary objectives include assessing the effects of VR on physiological arousal parameters, patient satisfaction, and safety.

Вмешательства

  • Другое Virtual Reality (VR)
    Participants will wear a virtual reality headset with headphones during outpatient ingrown toenail surgery performed under local anesthesia. The VR intervention consists of immersive nature-based audiovisual content, including forest, ocean, and tropical beach environments accompanied by relaxing natural sounds, and is used as a non-pharmacological distraction technique throughout the procedure.

Первичные конечные точки

  • State anxiety score [Срок оценки: Baseline (before the procedure) and 30 minutes after completion of the procedure.]
  • Pain intensity (Visual Analog Scale, VAS) [Срок оценки: Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after completion of the procedure.]
Вторичные конечные точки (2)
  • Heart rate [Срок оценки: Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after the procedure.]
  • Blood pressure [Срок оценки: Baseline (before the procedure), within 2 minutes after digital nerve block, and 30 minutes after the procedure.]

Критерии участия

Критерии включения

  • Adults aged 18-65 years.
  • Patients presenting to the Dermatology Outpatient Clinic of Ankara Bilkent City Hospital with ingrown toenails who are scheduled for surgical treatment based on the severity and recurrence of the condition.
  • Ability to provide written informed consent.

Критерии исключения

  • Inability to read, understand, or sign the informed consent form.
  • Active infection, including infection at the surgical site.
  • History of epilepsy or seizures of any etiology
  • Hearing impairment or requirement for a hearing aid that would interfere with the VR intervention or study instructions. 6. Presence of a cardiac pacemaker or any implanted medical device.
  • History of neurological disorders (e.g., migraine).
  • Inability to understand or speak Turkish.
  • Active psychiatric disorder, use of anxiolytic or antidepressant medication that may influence anxiety assessment, panic disorder, or claustrophobia.
  • Visual impairment preventing the use of the VR device.
  • Cardiac or metabolic disorders that may affect heart rate.
  • History of vertigo.
  • Cervical spine disorders involving the head or neck region.
  • Known anemia, history of methemoglobinemia, or glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Known allergy to local anesthetics.
  • Previous ingrown toenail surgery.

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
Другое

Центры проведения

Turkey (Türkiye) · 1 центр
  • Ankara Bilkent City Hospital — Ankara

Публикации

  • Wong CL, Choi KC. Effects of an Immersive Virtual Reality Intervention on Pain and Anxiety Among Pediatric Patients Undergoing Venipuncture: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230001. doi: 10.1001/jamanetworkopen.2023.0001. PMID 36795410
  • Goktay F, Altan ZM, Talas A, Akpinar E, Ozdemir EO, Aytekin S. Anxiety Among Patients Undergoing Nail Surgery and Skin Punch Biopsy: Effects of Age, Gender, Educational Status, and Previous Experience. J Cutan Med Surg. 2016 Jan;20(1):35-9. doi: 10.1177/1203475415588645. Epub 2015 Jun 3. PMID 26040581
  • Exley V, Jones K, O'Carroll G, Watson J, Backhouse M. A systematic review and meta-analysis of randomised controlled trials of surgical treatments for ingrown toenails part II: healing time, post-operative complications, pain, and participant satisfaction. J Foot Ankle Res. 2023 Sep 6;16(1):55. doi: 10.1186/s13047-023-00655-7. PMID 37674170

Идентификаторы

NCT: NCT07707726 · 2026-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗