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Набор по приглашению NCT07176013

Immersive Virtual Reality Meditation in Voice Therapy

Без фазы С лечением Voice Disorders

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: Voice therapy, Meditation, Virtual Reality.
Кому может быть актуально
Состояния в реестре: Voice Disorders. Базовые параметры: от 18 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
США
Следующий шаг
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Официальное название

Immediate and Cumulative Effects of Meditation on Voice Therapy Using Immersive Virtual Reality (IVR)

Обзор

This study aims to explore the feasibility of incorporating regular guided meditations via immersive virtual reality (IVR) at the start of voice therapy sessions to facilitate better learning and retention of treatment. The study will involve 30 participants, and use the TRIPP application with the Meta Quest 2 virtual reality headset, known for its immersive meditation experiences designed to calm or focus the user. The objective is to investigate the immediate effects of meditation/mindfulness in IVR on vocal production, with the goal of improving self-regulation, attentional focus, and reducing vocal hyperfunction. IVR has been utilized in mental health settings and exposure therapy for various conditions, but its application in voice therapy, particularly for anxiety reduction through fully immersive meditation, remains unexplored. The study seeks to determine whether IVR can enhance therapy outcomes by improving engagement, attention, and vocal control in individuals undergoing voice therapy, potentially maximizing treatment gains. Through this research, the aim is to assess the efficacy of IVR in enhancing voice therapy interventions and addressing the unique challenges posed by stress and anxiety in voice users.

Вмешательства

  • Поведенческое Voice therapy
    All patients will receive a course of voice therapy as normal.
  • Поведенческое Meditation
    Meditation at the start of each session. (each session is 30 minutes)
  • Устройство Virtual Reality
    TRIPP application in the Meta Quest 2 Virtual Reality Headset.

Первичные конечные точки

  • Maximum Phonation Time (MPT) [Срок оценки: at each therapy session (approximately 1 week apart over 4 weeks)]
  • Noise-to-Harmonic Ratio (NHR) [Срок оценки: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
  • Cepstral Peak Prominence (CPPS) [Срок оценки: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
  • Acoustic Vocal Quality Index (AVQI) [Срок оценки: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
Вторичные конечные точки (7)
  • Voice Handicap Index [Срок оценки: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
  • State Trait Anxiety Inventory Y-1 (STAI-1), long form [Срок оценки: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
  • State Trait Anxiety Inventory Y-1 (STAY Y-1), short form [Срок оценки: Immediately pre- and immediately post-meditation in each therapy session, over approximately 4 weeks]
  • State Trait Anxiety Inventory Y-2 (STAI Y-2), long form [Срок оценки: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
  • Vocal Fatigue Index [Срок оценки: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
  • CAPE-V, Consensus on Auditory-Perceptual Evaluation of Voice [Срок оценки: Pre-intervention (within 1 week before first session) and post-intervention (within 1 week after final session]
  • Heart rate measured in beats per minute [Срок оценки: Immediately pre- and immediately post-meditation in each therapy session, over approximately 4 weeks]

Критерии участия

Критерии включения

  • Patients with voice disorders, difficulties or laryngeal hypersensitivity, and who also have anxiety
  • Must have availability to participate for entire course of 5 consistent weeks

Критерии исключения

  • Anyone not meeting inclusion criteria
  • Presence of any additional medical condition significantly affecting:
  • Respiratory function (e.g., advanced lung disease)
  • Laryngeal function (e.g., status-post deep brain stimulation)
  • Lingual function
  • Velopharyngeal function (e.g., laryngectomy)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Mount Sinai Downtown Union Square — New York

Идентификаторы

NCT: NCT07176013 · STUDY-24-01217

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗