Меню
Идёт набор NCT05440760

Using Virtual Reality Technology to Improve Patient Experience and Quality of Care During Brachytherapy

Без фазы С лечением Endocervical Cancer

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: The Oculus Quest 2 Virtual Reality Headset.
Кому может быть актуально
Состояния в реестре: Endocervical Cancer. Базовые параметры: от 18 лет · Женщины.
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The primary objective is to demonstrate the feasibility of incorporating VR distraction into the brachytherapy and radiotherapy clinical workflow. The secondary objective is to determine if VR distraction during brachytherapy treatment for cervical cancer improves subjects' satisfaction, procedural/acute pain, and need for analgesics or anxiolytics.

Подробное описание

This will be a prospective pilot study conducted at UAMS. All subjects will experience VR distraction using a crossover design in which each subject receives four rounds of brachytherapy: two rounds with VR distraction and two rounds without VR distraction. Brachytherapy will be conducted per SoC workflow. Subjects will be placed into four treatment-sequence groups in a 1:1:1:1 allocation ratio via permuted block randomization with randomized block sizes of four or eight.

The four treatment-sequence groups will follow the four-session treatment schedules outlined below, in which "V" denotes the sessions when VR distraction is used while "N" denotes the sessions when it is not:

* Sequence Group A will be treated according to schedule VVNN. * Sequence Group B will be treated according to schedule VNNV. * Sequence Group C will be treated according to schedule NNVV. * Sequence Group D will be treated according to schedule NVVN.

Вмешательства

  • Устройство The Oculus Quest 2 Virtual Reality Headset
    The hardware includes the wireless headset with integrated headphones which will block the sight and sounds of the clinical setting as well as the hand controllers for the interactive VR experience, which will be delivered through any of three VR software options (subject may choose one or more from the following options): * Titans of Space® PLUS developed by Drash VR, LLC (Murrieta, CA, USA) * TRIPP® developed by TRIPP, Inc. (Los Angeles, CA, USA) * Nature Treks VR published by Greener Games (

Первичные конечные точки

  • The number of eligible subjects who enroll onto the study. [Срок оценки: 3 weeks]
  • The number of subjects who withdraw or are withdrawn from the study. [Срок оценки: 3 weeks]
  • The number of subjects who successfully complete the study questionnaires for satisfaction, procedural pain, and anxiety. [Срок оценки: 3 weeks]
  • The number of times a technical problem occurs with the VR distraction [Срок оценки: 3 weeks]
Вторичные конечные точки (4)
  • Determination of VR distraction during brachytherapy treatment for cervical cancer pain [Срок оценки: 3 weeks]
  • Determination of VR distraction during brachytherapy treatment for cervical cancer on anxiety. [Срок оценки: 3 weeks]
  • Opiod dose [Срок оценки: 3 weeks]
  • Benzodiazepine dose [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

  • Female, ≥ 18 years of age
  • Histopathologic diagnosis of gynecologic cancer (endometrial, cervical, vaginal, vulvar) that requires intracavitary brachytherapy with a tandem or interstitial brachytherapy
  • Able to provide written consent

Критерии исключения

  • Severe vision or hearing problems that may hinder the ability to see or hear clearly through the VR headset or other condition that may interfere with the placement of the VR headset such as a head, ear or facial wound
  • History of seizure disorder, severe motion sickness, dizziness, or migraine headaches precipitated by visual auras
  • Known history of elevated intraocular pressure
  • Claustrophobia, thalassophobia, cleithrophobia or similar phobias
  • Any other significant medical or psychiatric conditions which, in the opinion of the enrolling investigator, may interfere with consent or compliance of the treatment regimen

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
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

США · 1 центр
  • University of Arkansas for Medical Sciences — Little Rock

Идентификаторы

NCT: NCT05440760 · 261231

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗