VR Based Simulation in the Preparation of Children for MRI - MRVR
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: VR, Booklet.
- Кому может быть актуально
- Состояния в реестре: Children, Only, Anesthesia. Базовые параметры: 4 лет — 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
- Венгрия
- 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
Efficacy of Virtual Reality Based Simulation in the Preparation of Children for Magnetic Resonance Imaging Examinations: a Randomized Clinical Trial (MRVR)
Обзор
The goal of this randomized controlled trial is to evaluate whether a virtual reality based preparation method can efficiently decrease the proportion of children requiring general anesthesia during MRI examinations. Participants will take part in a virtual reality environment resembling an MRI before their scheduled MRI examination. Researchers will compare these children to usual care and a booklet based preparation method to see if less children need anesthesia for completing the MRI examination.
Подробное описание
Study Description:
Our study investigates the efficacy of a custom-made virtual reality experience in the preparation of children for MRI examinations. We hypothesise that preparation with VR can significantly reduce the need for anesthesia in children during MRI examinations, or if anesthesia is needed less doses of anesthetics are required.
Objectives:
Primary Objective:
To evaluate whether the VR based preparation decreases the need for anesthesia and sedation during MRI examinations.
Secondary Objectives:
To evaluate whether fear, mood, anxiety, familiarity with the MRI examination of the children and willingness to take part again change as a result of the intervention.
Endpoints:
Primary Endpoint:
The need for any anesthetic or sedative medication during MRI examination.
Secondary Endpoints:
Visual analogue scales related to fear, mood and familiarity, willingness to take part in an MRI examination again.
Study Population: 288 children aged 4-18 years who are in- or outpatients at the Pediatric Center of the Semmelweis University and are scheduled for MRI examination with anesthesia will be enrolled.
Description of Sites/Facilities Enrolling Participants:
The study takes place in the two Departments of the Pediatric Centre of the Semmelweis University
Description of Study Intervention/Experimental Manipulation:
Our research will be conducted as a three arm randomized controlled trial (VR, booklet, usual care). Participants in the VR condition are immersed in a unique 360° VR experience specifically designed for this study.
Children in the booklet condition will be prepared by using an educational booklet containing colorful illustrations about the MRI examination.
In the usual care condition children are prepared by the healthcare staff without using any specific equipment or standardized methods.
Study Duration:
36 months
Participant Duration:
All participants need a single visit intervention to complete all study related tasks.
Вмешательства
- Другое VR
The virtual environment is provided by the Oculus Quest 2 or 3 VR headset, providing a high-quality and immersive visual experience. - Другое Booklet
Children in the booklet condition will be prepared by using an educational booklet containing colorful illustrations of the MRI examination room and about the procedure.
Первичные конечные точки
- proportion of children requiring anesthesia [Срок оценки: during the MRI examination, assessed directly after the MRI from anesthesiology documentation]
Вторичные конечные точки (6)
- fear [Срок оценки: assessed directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination]
- mood [Срок оценки: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination]
- nervousness [Срок оценки: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination]
- familiarity [Срок оценки: directly before the intervention, directly before the MRI examination, no later than 4 hours after the MRI examination]
- willingness to take part again [Срок оценки: no later than 4 hours after the MRI examination]
- helpfulness [Срок оценки: directly before the MRI examination]
Критерии участия
Критерии включения
- Informed assent and parental informed consent to participate in the study.
- Stated willingness to participate in the intervention and to complete study questionnaires.
- Inpatient or outpatient at the Pediatric Center.
- Age 4-18 years
- Scheduled for MRI examination under anesthesia at the Semmelweis University.
- Fluent in Hungarian language
Критерии исключения
- Severe visual impairment or hearing loss that would hinder the participation of the VR and booklet experience.
- In case of epilepsy, if the treating physician recommend against participation.
- Children with severe intellectual disability which would hinder participation in the VR group e.g. not able to follow simple instructions.
- Inpatients, if the treating physician indicates that the child is too unwell for the study.
- Face or cranial deformities, wounds on the face and head which would hinder wearing the VR headset.
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
- Тройное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Венгрия · 1 центр
- Pediatric Center, Semmelweis University — Budapest
Идентификаторы
NCT: NCT06132854 · SE RKEB 202/2021